A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome

A Two-Part Study of ZX008 in Children and Adults With Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults With LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults With LGS

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03355209

Enrollment

296

Registered

2017-11-28

Start date

2017-11-27

Completion date

2024-05-23

Last updated

2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lennox Gastaut Syndrome

Keywords

LGS

Brief summary

This is a two-part, multicenter, double-blind, parallel-group, placebo controlled study to evaluate the effect of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with Lennox-Gastaut syndrome (LGS).

Interventions

DRUGZX008 0.2 or 0.8 mg/kg/day

ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free and is intended to be compatible with a Ketogenic Diet.

DRUGMatching Placebo

Placebo will be administered twice a day (BID) in equally divided doses.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Part 1: Double-Blind Part 2: Open-Label

Intervention model description

Part 1: Double-Blind ZX008 - (0.2 mg/kg/day or 0.8mg/kg/day) or Placebo and Part 2: Open-Label

Eligibility

Sex/Gender

ALL

Age

2 Years to 35 Years

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Male or non-pregnant, non-lactating female, age 2 to 35 years, inclusive as of the day of the Screening Visit. * Clinical diagnosis of Lennox-Gastaut syndrome, where seizures that result in drops are not completely controlled by current antiepileptic treatments. * Onset of seizures at 11 years of age or younger. * Abnormal cognitive development. * Must be receiving at least 1 concomitant AED and up to 4 concomitant anti-epileptic treatments. Key

Exclusion criteria

* Etiology of seizures is a degenerative neurological disease. * History of hemiclonic seizures in the first year of life. * Subject only has drop seizures in clusters, where individual seizures cannot be counted reliably. * Pulmonary arterial hypertension. * Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction or stroke. * Receiving concomitant therapy with: centrally-acting anorectic agents; monoamineoxidase inhibitors; any centrally-acting compound with clinically appreciable amount of serotonin agonist or antagonist properties, including serotonin reuptake inhibition; atomoxetine, or other centrally-acting noradrenergic agonist; cyproheptadine. * Taking felbamate for less than 1 year prior to screening and/or does not have stable liver function and hematology laboratory tests, and/or the dose has not been stable for at least 60 days prior to the Screening Visit. * Currently receiving an investigational product. * Institutionalized in a general nursing home (ie, in a facility that does not specialize in epilepsy care). * A clinically significant condition, or has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to the Screening Visit, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the subject.

Design outcomes

Primary

Measure	Time frame	Description
Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC-confirmed) in the Combined Titration and Maintenance Period (T+M) in the ZX008 0.8 mg/kg/Day Group Compared to the Placebo Group	From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]	Percent change in frequency of seizures that result in drops (DSF: drop seizure frequency) per 28 days between the combined Titration and Maintenance (T+M) and Baseline. The percent change from Baseline DSF was calculated as the change in DSF between T+M and Baseline / DSF during Baseline\* 100. The seizure types included in the count were: atonic, tonic, tonic/atonic, generalized tonic-clonic, and secondarily generalized tonic-clonic seizures resulting in drops.
Part 2: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	From Part 2 Baseline until end of the OLE Period (up to 72 months)	An Adverse event (AE) was defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of investigational product, or whether considered related to the investigational product. A TEAE in Part 2 was defined as any AE with an onset on or after the first dose in Part 2. AEs with onset in Part 1 that are ongoing in Part 2 were not included in the count of AEs in Part 2.
Part 2: Percentage of Participants With Serious TEAEs	From Part 2 Baseline until end of the OLE Period (up to 72 months)	A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose: Results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is medically significant.

Secondary

Measure	Time frame	Description
Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC-confirmed) in T+M in the ZX008 0.2 mg/kg/Day Group Compared to the Placebo Group	From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]	Percent change in frequency of seizures that result in drops (DSF: drop seizure frequency) per 28 days between the combined Titration and Maintenance (T+M) and Baseline. The percent change from Baseline DSF was calculated as the change in DSF between T+M and Baseline / DSF during Baseline\* 100. The seizure types included in the count were: atonic, tonic, tonic/atonic, generalized tonic-clonic, and secondarily generalized tonic-clonic seizures resulting in drops.
Part 1: Percentage of Participants Who Achieve a >=50% Reduction From Baseline in the Frequency of Seizures That Result in Drops Comparing the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]	The seizure types included in the count were: atonic, tonic, tonic/atonic, generalized tonic-clonic, and secondarily generalized tonic-clonic seizures resulting in drops. Participants who achieved a \>=50% reduction from Baseline in the DSF, ie, a decrease in DSF of at least 50 percentage points per 28 days during Titration and Maintenance Period.
Part 1: Percentage of Participants Who Achieve Improvement (Minimally, Much or Very Much Improved) in the CGI-I Scale as Assessed by Principal Investigator Comparing ZX008 0.8 and 0.2 mg/kg/Day Groups Independently Versus Placebo	At Day 99 (Visit 12)	Clinical Global Impression - Improvement (CGI-I) scale measures improvement in the participant's condition from Baseline. The severity of a participant's condition was rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), as follows: 1-very much improved,2-much improved, 3-minimally improved, 4- no change, 5-minimally worse, 6-much worse and 7-very much worse.
Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC Confirmed) Between Baseline and the Maintenance Period	During Maintenance Period (12 weeks), compared to Baseline	The frequency of drop seizures during a given interval was derived from the number and type of events recorded in participant electronic diaries. The seizure types included in the count were: atonic, tonic, tonic/atonic, generalized tonic-clonic, and secondarily generalized tonic-clonic seizures resulting in drops.
Part 1: Percent Change From Baseline in Frequency of All Seizures That Typically Result in Drops in T+M, Whether ESC-confirmed as Drop or Not in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]	Seizures that typically result in drops included all: generalized tonic-clonic seizures \[GTC\], secondarily generalized tonic-clonic \[SGTC\], tonic seizures \[TS\], atonic seizures \[AS\], and tonic/atonic seizures \[TA\], whether confirmed by the ESC or not. Seizures that result in a drop were defined as seizures involving the entire body, trunk, or head that led to a fall, injury, slumping in a chair, or the participant's head hitting a surface or that could have led to a fall or injury, depending on the patient's position at the time of the seizure.
Part 1: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]	Countable motor seizures included: GTC, SGTC, TS, AS, TA, clonic seizures \[CS\], hemiclonic seizures \[HS\], and focal seizures \[FS\] with clearly observable signs.
Part 1: Change From Baseline in the Frequency of All Countable Non-motor Seizures in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]	Countable non-motor seizures included: focal seizures \[FS\] without clear observable signs, myoclonic seizures \[MS\], absence/atypical absence, infantile spasms, epileptic spasms, and other seizures. For each participant, the seizure frequency per 28 days was calculated as the number of seizures recorded during the period, divided by the number of days in the period and multiplied by 28.
Part 1: Percent Change From Baseline in the Frequency of All Countable Seizures (Motor and Non-motor) in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]	Countable motor seizures included: GTC, SGTC, TS, AS, TA, CS, HS, and FS with clearly observable signs. Countable non-motor seizures included: FS without clear observable signs, MS, absence/atypical absence, infantile spasms, epileptic spasms, and other seizures.
Part 1: Percent Change From Baseline in the Frequency of Seizures That Typically Result in Drops in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	During Maintenance Period (12 weeks), compared to Baseline	Seizures that typically result in drops included all: GTC, SGTC, TS, AS, and TA, whether confirmed by the ESC or not.
Part 1: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	During Maintenance Period (12 weeks), compared to Baseline	Countable motor seizures included: GTC, SGTC,TS, AS, TA, CS, HS, and FS with clearly observable signs.
Part 1: Change From Baseline in the Frequency of All Countable Non-motor Seizures in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	During Maintenance Period (12 weeks), compared to Baseline	Countable non-motor seizures included: focal seizures \[FS\] without clear observable signs, myoclonic seizures \[MS\], absence/atypical absence, infantile spasms, epileptic spasms, and other seizures. For each participant, the seizure frequency per 28 days was calculated as the number of seizures recorded during the period, divided by the number of days in the period and multiplied by 28.
Part 1: Percent Change From Baseline in the Frequency of All Countable Seizures (Motor and Non-motor) in the Maintenance Period in ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	During Maintenance Period (12 weeks), compared to Baseline	Countable motor seizures included: GTC, SGTC, TS, AS, TA, CS, HS, and FS with clearly observable signs. Countable non-motor seizures included: FS without clear observable signs, MS, absence/atypical absence, infantile spasms, epileptic spasms, and other seizures.
Part 1: Percent Change From Baseline in Frequency of Countable Seizures That do Not Result in Drops (ESC Confirmed)	From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]	Non-drop seizures were defined as any countable seizure types that did not meet the criteria of drop seizures, ie, are classified as CS, HC, FS with or without observable signs, MS, absence/atypical absence, infantile spasms, epileptic spasms, or other; or are seizures of the following classifications that were approved for each participant as non-drop seizure types by the ESC: GTC, SGTC, TS, AS, or TA.
Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]; During Maintenance Period (12 weeks), compared to Baseline	The seizure types included in the count were: atonic, tonic, tonic/atonic, generalized tonic-clonic, and secondarily generalized tonic-clonic seizures resulting in drops. The participants who experienced a worsening or no change from Baseline (ie \<= 0% reduction); \>0%, \>=25%, \>=50%, \>=75%, and 100% reduction (a 100% reduction was equivalent to achieving seizure freedom during T+M); and near seizure freedom, (defined as 0 or 1 seizure leading to a drop) during combined T+M Period and Maintenance Period were reported.
Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]; During Maintenance Period (12 weeks), compared to Baseline	Seizures that typically result in drops included all: GTC, SGTC, TS, AS, and TA, whether confirmed by the ESC or not. The participants who experienced a worsening or no change from Baseline (ie \<= 0% reduction); \>0%, \>=25%, \>=50%, \>=75%, and 100% reduction (a 100% reduction was equivalent to achieving seizure freedom during T+M); and near seizure freedom, (defined as 0 or 1 seizure leading to a drop) during combined T+M Period and Maintenance Period were reported.
Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]; During Maintenance Period (12 weeks), compared to Baseline	Countable motor seizures included: GTC, SGTC, TS, AS, TA, CS, HS, and FS with clearly observable signs. The participants who experienced a worsening or no change from Baseline (ie \<= 0% reduction); \>0%, \>=25%, \>=50%, \>=75%, and 100% reduction (a 100% reduction was equivalent to achieving seizure freedom during T+M); and near seizure freedom, (defined as 0 or 1 seizure leading to a drop) during combined T+M Period and Maintenance Period were reported.
Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]; During Maintenance Period (12 weeks), compared to Baseline	Countable motor seizures included: GTC, SGTC; TS, AS, TA, CS, HS, FS with clearly observable signs. The participants who experienced a worsening or no change from Baseline (ie \<= 0% reduction); \>0%, \>=25%, \>=50%, \>=75%, and 100% reduction (a 100% reduction was equivalent to achieving seizure freedom during T+M); and near seizure freedom, (defined as 0 or 1 seizure leading to a drop) during combined T+M Period and Maintenance Period were reported.
Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]; During Maintenance Period (12 weeks), compared to Baseline	Countable motor seizures included: GTC, SGTC; TS, AS, TA, CS, HS, and FS with clearly observable signs. Countable non-motor seizures included: FS without clear observable signs, MS, absence/atypical absence, infantile spasms, epileptic spasms, and other seizures. The participants who experienced a worsening or no change from Baseline (ie \<= 0% reduction); \>0%, \>=25%, \>=50%, \>=75%, and 100% reduction (a 100% reduction was equivalent to achieving seizure freedom during T+M); and near seizure freedom, (defined as 0 or 1 seizure leading to a drop) during combined T+M Period and Maintenance Period were reported.
Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]; During Maintenance Period (12 weeks), compared to Baseline	Countable non-motor seizures include: FS without clear observable signs, MS, absence/atypical absence, infantile spasms, epileptic spasms, and other seizures. The participants who experienced a worsening or no change from Baseline (ie \<= 0% reduction); \>0%, \>=25%, \>=50%, \>=75%, and 100% reduction (a 100% reduction was equivalent to achieving seizure freedom during T+M); and near seizure freedom, (defined as 0 or 1 seizure leading to a drop) during combined T+M Period and Maintenance Period were reported.
Part 1: Change From Baseline in Number of Seizure-free Days During T+M and M Period	From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]; During Maintenance Period (12 weeks), compared to Baseline	A day with no seizures leading to a drop was defined as a day for which electronic (e) diary data were available and no drop seizures were reported. The total number of drop seizure-free days was calculated per 28 days for Baseline and for T+M.
Part 1: Duration of Longest Interval (Days) Between Seizures That Result in Drops Comparing the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]	The longest interval between seizures leading to drops were obtained from the eDiary entries in Titration and Maintenance Period. The interval was derived as the maximum value of the number of days between consecutive drop seizures.
Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	At Days 15, 43, 71 and 99	CGI-I scale measures improvement in the participant's condition from Baseline. The severity of a participant's condition was rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), as follows: 1-very much improved, 2-much improved, 3-minimally improved, 4- no change, 5-minimally worse, 6-much worse and 7-very much worse.
Part 1: Percentage of Participants With TEAEs	Baseline up to 14 weeks + Taper/Transition (2 weeks)	Adverse events were defined as any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A TEAE in Part 1 was defined as any AE that, based on start date information, occurred after the first dose of study drug in Part 1, but not on or after the first dose of study drug in Part 2.
Part 1: Percentage of Participants With Serious TEAEs	Baseline up to 14 weeks + Taper/Transition (2 weeks)	A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose: Results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is medically significant.
Part 1: Maximum Observed Plasma Concentration of Fenfluramine and Norfenfluramine Determined Directly From the Concentration Time Profile [Cmax] at Steady State	At Visit 8 (Day 43) of the Maintenance Period: pre-dose, 1, 2, and 4-6 hours post-dose	Cmax is the maximum plasma concentration determined directly from the concentration time profile.
Part 1: Minimum Observed Plasma Concentration of Fenfluramine and Norfenfluramine at Steady State Determined Directly From the Concentration-time Profile [Cmin] at Steady State	At Visit 8 (Day 43) of the Maintenance Period: pre-dose, 1, 2, and 4-6 hours post-dose	Cmin is the minimum plasma concentration determined directly from the concentration-time profile.
Part 1: Area Under the Concentration-time Curve of Fenfluramine and Norfenfluramine From Time Zero to Time 24 Hours [AUC0-24hours] at Steady State	At Visit 8 (Day 43) of the Maintenance Period: pre-dose, 1, 2, and 4-6 hours post-dose	AUC0-24 is the area under the concentration-time curve from time 0 to 24 hours.
Part 2: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC Confirmed) in OLE Period	From OLE Month 1 to Month12, compared to Baseline (Part 1)	The frequency of drop seizures during a given interval was derived from the number and type of events recorded in participant electronic diaries. The seizure types included in the count were: atonic, tonic, tonic/atonic, generalized tonic-clonic, and secondarily generalized tonic-clonic seizures resulting in drops.
Part 2: Percent Change From Baseline in the Frequency of All Seizures That Typically Result in Drops Between Baseline and the OLE Period Whether ESC Confirmed as Drop or Not	From OLE Month 1 to Month12, compared to Baseline (Part 1)	Seizures that typically result in drops included all: generalized tonic-clonic seizures \[GTC\], secondarily generalized tonic-clonic \[SGTC\], tonic seizures \[TS\], atonic seizures \[AS\], and tonic/atonic seizures \[TA\], whether confirmed by the ESC or not. Seizures that result in a drop were defined as seizures involving the entire body, trunk, or head that led to a fall, injury, slumping in a chair, or the participant's head hitting a surface or that could have led to a fall or injury, depending on the patient's position at the time of the seizure.
Part 2: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in OLE Period	From OLE Month 1 to Month12, compared to Baseline (Part 1)	Countable motor seizures included: GTC, SGTC, TS, AS, TA, clonic seizures \[CS\], hemiclonic seizures \[HS\], and focal seizures \[FS\] with clearly observable signs.
Part 2: Change From Baseline in the Frequency of All Countable Non-motor Seizures in OLE Period	From OLE Month 1 to Month12, compared to Baseline (Part 1)	Countable non-motor seizures included: focal seizures \[FS\] without clear observable signs, myoclonic seizures \[MS\], absence/atypical absence, infantile spasms, epileptic spasms, and other seizures. For each participant, the seizure frequency per 28 days was calculated as the number of seizures recorded during the period, divided by the number of days in the period and multiplied by 28.
Part 2: Percent Change From Baseline in the Frequency of All Countable Seizures (ESC Confirmed or Not) in OLE Period	From OLE Month 1 to Month12, compared to Baseline (Part 1)	Countable motor seizures included: GTC, SGTC, TS, AS, TA, CS, HS, and FS with clearly observable signs. Countable non-motor seizures included: FS without clear observable signs, MS, absence/atypical absence, infantile spasms, epileptic spasms, and other seizures.
Part 2: Change From Baseline in the Frequency of All Countable Seizures That Did Not Result in Drops (ESC Confirmed) in OLE Period	From OLE Month 1 to Month12, compared to Baseline (Part 1)	Nondrop seizures were defined as any countable seizure types that did not meet the criteria of drop seizures, ie, are classified as CS, HC, FS with or without observable signs, MS, absence/atypical absence, infantile spasms, epileptic spasms, or other; or are seizures of the following classifications that were approved for each subject as non-drop seizure types by the ESC: GTC, SGTC, TS, AS, or TA. For each participant, the seizure frequency per 28 days was calculated as the number of seizures recorded during the period, divided by the number of days in the period and multiplied by 28.
Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Result in Drops (ESC Confirmed)	From OLE Month 1 to Month12, compared to Baseline (Part 1)	The seizure types included in the count were: atonic, tonic, tonic/atonic, generalized tonic-clonic, and secondarily generalized tonic-clonic seizures resulting in drops. The participants who experienced a worsening or no change from Baseline (ie \<= 0% reduction); \>0%, \>=25%, \>=50%, \>=75%, and 100% reduction (a 100% reduction was equivalent to achieving seizure freedom during OLE Period); and near seizure freedom, (defined as 0 or 1 seizure leading to a drop) during OLE Period were reported.
Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Typically Result in Drops	From OLE Month 1 to Month12, compared to Baseline (Part 1)	Seizures that typically result in drops included all: GTC, SGTC, TS, AS, and TA, whether confirmed by the ESC or not. The participants who experienced a worsening or no change from Baseline (ie \<= 0% reduction); \>0%, \>=25%, \>=50%, \>=75%, and 100% reduction (a 100% reduction was equivalent to achieving seizure freedom during OLE Period); and near seizure freedom, (defined as 0 or 1 seizure leading to a drop) during OLE Period were reported.
Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Motor Seizures	From OLE Month 1 to Month12, compared to Baseline (Part 1)	Countable motor seizures included: GTC, SGTC, TS, AS, TA, CS, HS, and FS with clearly observable signs. The participants who experienced a worsening or no change from Baseline (ie \<= 0% reduction); \>0%, \>=25%, \>=50%, \>=75%, and 100% reduction (a 100% reduction was equivalent to achieving seizure freedom during OLE Period); and near seizure freedom, (defined as 0 or 1 seizure leading to a drop) during OLE Period were reported.
Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Non-motor Seizures	From OLE Month 1 to Month12, compared to Baseline (Part 1)	Countable non-motor seizures included: FS without clear observable signs, MS, absence/atypical absence, infantile spasms, epileptic spasms, and other seizures. The participants who experienced a worsening or no change from Baseline (ie \<= 0% reduction); \>0%, \>=25%, \>=50%, \>=75%, and 100% reduction (a 100% reduction was equivalent to achieving seizure freedom during OLE Period); and near seizure freedom, (defined as 0 or 1 seizure leading to a drop) during OLE Period were reported.
Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Seizures	From OLE Month 1 to Month12, compared to Baseline (Part 1)	Countable motor seizures included: GTC, SGTC; TS, AS, TA, CS, HS, and FS with clearly observable signs. Countable non-motor seizures included: FS without clear observable signs, MS, absence/atypical absence, infantile spasms, epileptic spasms, and other seizures. The participants who experienced a worsening or no change from Baseline (ie \<= 0% reduction); \>0%, \>=25%, \>=50%, \>=75%, and 100% reduction (a 100% reduction was equivalent to achieving seizure freedom during OLE Period); and near seizure freedom, (defined as 0 or 1 seizure leading to a drop) during OLE Period were reported.
Part 2: Change From Baseline in Number of Seizure-free Days Per 28 Days (ESC Confirmed) in OLE Period	From Part 2 Baseline until end of OLE Period (up to 72 months)	A day with no seizures leading to a drop was defined as a day for which ediary data were available and no drop seizures were reported.
Part 2: Change From Baseline in Duration of Longest Interval Between Seizures That Result in Drops (ESC Confirmed) in OLE Period	From Part 2 Baseline until end of the OLE Period (up to 72 months)	The longest interval between seizures leading to drops were obtained from the eDiary entries in OLE Period. The interval was derived as the maximum value of the number of days between consecutive drop seizures.
Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	At OLE Day 1, OLE Months (M) 1, 2, 3, 6, 9, 12, and Last Assessment (up to 72 months)	CGI-I scale measures improvement in the participant's condition from Baseline. The severity of a participant's condition was rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), as follows: 1-very much improved,2-much improved, 3-minimally improved, 4- no change, 5-minimally worse, 6-much worse and 7-very much worse.
Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	At OLE Day 1, OLE Months (M) 1, 2, 3, 6, 9, 12, and Last Assessment (up to 72 months)	CGI-I scale measures improvement in the participant's condition from Baseline. The severity of a participant's condition was rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), as follows: 1-very much improved,2-much improved, 3-minimally improved, 4- no change, 5-minimally worse, 6-much worse and 7-very much worse.

Countries

Australia, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Mexico, Netherlands, Poland, Spain, Sweden, United States

Participant flow

Recruitment details

The study started to enroll participants in November 2017 and concluded in May 2024. Cohort A included participants enrolled at sites in North America, Europe, and Australia. Cohort B included participants enrolled at sites in Japan only.

Pre-assignment details

The Participant Flow refers to the All Enrolled Participants Set for Part 1 and OLE Safety Population for Part 2 of the study. As planned, Part 2 summaries were presented by the participant's Part 1 treatment groups (placebo, ZX008 0.2 mg/kg/day, ZX008 0.8 mg/kg/day).

Participants by arm

Arm	Count
Cohort A: Placebo Part 1: Participants received matching placebo as an oral solution, twice a day (bid) over 2 weeks of Titration Period and an additional 12 weeks of Maintenance Period. Participants who completed the Maintenance Period and did not continue in Part 2, and participants who discontinued from Part 1 early, were tapered off study medication over 8 days. In Part 2 (OLE Period): Participants initially received ZX008 0.2 mg/kg/day for 1 month. After 1 month, the Investigator could adjust the dose if needed. Participants received ZX008 for up to 12 months in OLE Period.	87
Cohort A: ZX008 0.2 mg/kg/Day Part 1: Participants received ZX008 0.2 milligram per kilogram per day (mg/kg/day) during the 2-week Titration. Following titration, participants received ZX008 0.2 mg/kg/day as an oral solution, bid for an additional 12 weeks during Maintenance Period. Participants who completed the Maintenance Period and did not continue in Part 2, and participants who discontinued from Part 1 early, were tapered off study medication over 8 days. In Part 2 (OLE Period): Participants initially received ZX008 0.2 mg/kg/day for 1 month. After 1 month at a dose of ZX008 0.2 mg/kg/day, the Investigator could adjust the dose if needed. Participants received ZX008 for up to 12 months in OLE Period.	89
Cohort A: ZX008 0.8 mg/kg/Day Part 1: Participants were titrated to their blinded randomized dose of ZX008 over the 2-week Titration from 0.2 mg/kg/day to ZX008 0.8 mg/kg/day (or a maximum dose of 30 mg/day or 20 mg/day for participants taking concomitant stiripentol \[STP\]). Following titration, participants continued to receive the randomized dose of ZX008 as an oral solution, bid for an additional 12 weeks during Maintenance Period. Participants who completed the Maintenance Period and did not continue in Part 2, and participants who discontinued from Part 1 early, were tapered off study medication over 8 days. In Part 2 (OLE Period): Participants initially received ZX008 0.2 mg/kg/day for 1 month. After 1 month at a dose of ZX008 0.2 mg/kg/day, the Investigator could adjust the dose if needed. Participants received ZX008 for up to 12 months in OLE Period.	87
Cohort B: Placebo Part 1: Participants received matching placebo as an oral solution, bid over 2 weeks of Titration Period and an additional 12 weeks of Maintenance Period. Participants who completed the Maintenance Period and did not continue in Part 2, and participants who discontinued from Part 1 early, were tapered off study medication over 8 days. In Part 2 (OLE Period): Participants initially received ZX008 0.2 mg/kg/day for 1 month. After 1 month at a dose of ZX008 0.2 mg/kg/day, the Investigator could adjust the dose if needed. Participants received ZX008 for up to 12 months in OLE Period. Participants who completed 12 months OLE Period had option to receive ZX008 for up to 72 months, or until ZX008 is approved in the participant's country.	11
Cohort B: ZX008 0.2 mg/kg/Day Part 1: Participants received ZX008 0.2 mg/kg/day during the 2-week Titration. Following titration, participants received ZX008 0.2 mg/kg/day as an oral solution, bid for an additional 12 weeks during Maintenance Period. Participants who completed the Maintenance Period and did not continue in Part 2, and participants who discontinued from Part 1 early, were tapered off study medication over 8 days. In Part 2 (OLE Period): Participants initially received ZX008 0.2 mg/kg/day for 1 month. After 1 month at a dose of ZX008 0.2 mg/kg/day, the Investigator could adjust the dose if needed. Participants received ZX008 for up to 12 months in OLE Period. Participants who completed 12 months OLE Period had option to receive ZX008 for up to 72 months, or until ZX008 is approved in the participant's country.	11
Cohort B: ZX008 0.8 mg/kg/Day Part 1: Participants were titrated to their blinded randomized dose of ZX008 over the 2-week Titration from 0.2 mg/kg/day to ZX008 0.8 mg/kg/day (or a maximum dose of 30 mg/day or 20 mg/day for participants taking concomitant STP). Following titration, participants continued to receive the randomized dose of ZX008 as an oral solution, bid for an additional 12 weeks during Maintenance Period. Participants who completed the Maintenance Period and did not continue in Part 2, and participants who discontinued from Part 1 early, were tapered off study medication over 8 days. In Part 2 (OLE Period): Participants initially received ZX008 0.2 mg/kg/day for 1 month. After 1 month at a dose of ZX008 0.2 mg/kg/day, the Investigator could adjust the dose if needed. Participants received ZX008 for up to 12 months in OLE Period. Participants who completed 12 months OLE Period had option to receive ZX008 for up to 72 months, or until ZX008 is approved in the participant's country.	11
Total	296

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005
Part 1: Double-Blind Period	Adverse Event	0	4	4	0	1	0
Part 1: Double-Blind Period	Death	0	0	1	0	0	0
Part 1: Double-Blind Period	Physician Decision	0	1	0	0	0	0
Part 1: Double-Blind Period	Withdrawal by Subject	1	1	1	0	0	0
Part 2:Open-Label Extension (OLE) Period	Adverse Event	5	5	3	0	1	1
Part 2:Open-Label Extension (OLE) Period	Death	0	1	0	0	0	0
Part 2:Open-Label Extension (OLE) Period	Lack of Efficacy	13	21	23	0	0	1
Part 2:Open-Label Extension (OLE) Period	Physician Decision	0	0	0	1	0	1
Part 2:Open-Label Extension (OLE) Period	Rollover into ZX008-1900	1	0	2	0	0	0
Part 2:Open-Label Extension (OLE) Period	Switching to commercial ZX008	0	0	0	5	6	3
Part 2:Open-Label Extension (OLE) Period	Withdrawal by Subject	6	5	4	0	2	0

Baseline characteristics

Characteristic	Cohort A: ZX008 0.2 mg/kg/Day	Cohort A: ZX008 0.8 mg/kg/Day	Cohort B: Placebo	Cohort B: ZX008 0.2 mg/kg/Day	Cohort B: ZX008 0.8 mg/kg/Day	Total	Cohort A: Placebo
Age, Continuous	13.4 years STANDARD_DEVIATION 7.79	13.4 years STANDARD_DEVIATION 7.28	18.5 years STANDARD_DEVIATION 7.78	20.1 years STANDARD_DEVIATION 7.79	18.5 years STANDARD_DEVIATION 7.94	14.3 years STANDARD_DEVIATION 7.76	14.4 years STANDARD_DEVIATION 7.71
Age, Customized 12 - < 18 years	23 Participants	25 Participants	5 Participants	2 Participants	3 Participants	87 Participants	29 Participants
Age, Customized 18 - 35 years	25 Participants	25 Participants	4 Participants	6 Participants	6 Participants	92 Participants	26 Participants
Age, Customized 2 - < 12 years	41 Participants	37 Participants	2 Participants	3 Participants	2 Participants	117 Participants	32 Participants
Race/Ethnicity, Customized Asian	3 Participants	4 Participants	11 Participants	11 Participants	11 Participants	42 Participants	2 Participants
Race/Ethnicity, Customized Black or African American	5 Participants	3 Participants	0 Participants	0 Participants	0 Participants	12 Participants	4 Participants
Race/Ethnicity, Customized Hispanic or Latino	21 Participants	14 Participants	0 Participants	0 Participants	0 Participants	51 Participants	16 Participants
Race/Ethnicity, Customized Multiple	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	3 Participants	2 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	58 Participants	66 Participants	11 Participants	11 Participants	11 Participants	222 Participants	65 Participants
Race/Ethnicity, Customized Not Reported	10 Participants	7 Participants	0 Participants	0 Participants	0 Participants	24 Participants	6 Participants
Race/Ethnicity, Customized Unknown	2 Participants	2 Participants	0 Participants	0 Participants	0 Participants	6 Participants	2 Participants
Race/Ethnicity, Customized White	67 Participants	70 Participants	0 Participants	0 Participants	0 Participants	208 Participants	71 Participants
Sex: Female, Male Female	43 Participants	33 Participants	5 Participants	2 Participants	2 Participants	126 Participants	41 Participants
Sex: Female, Male Male	46 Participants	54 Participants	6 Participants	9 Participants	9 Participants	170 Participants	46 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk
deaths Total, all-cause mortality	0 / 87	0 / 89	1 / 87	1 / 247	0 / 11	0 / 11	0 / 11	0 / 32
other Total, other adverse events	60 / 87	64 / 89	68 / 87	166 / 247	8 / 11	10 / 11	7 / 11	30 / 32
serious Total, serious adverse events	4 / 87	4 / 89	10 / 87	41 / 247	1 / 11	1 / 11	0 / 11	6 / 32

Outcome results

Primary

Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC-confirmed) in the Combined Titration and Maintenance Period (T+M) in the ZX008 0.8 mg/kg/Day Group Compared to the Placebo Group

Percent change in frequency of seizures that result in drops (DSF: drop seizure frequency) per 28 days between the combined Titration and Maintenance (T+M) and Baseline. The percent change from Baseline DSF was calculated as the change in DSF between T+M and Baseline / DSF during Baseline\* 100. The seizure types included in the count were: atonic, tonic, tonic/atonic, generalized tonic-clonic, and secondarily generalized tonic-clonic seizures resulting in drops.

Time frame: From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]

Population: The Modified Intent-to-Treat (mITT) Population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

Arm	Measure	Value (MEDIAN)
Cohort A: Placebo	Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC-confirmed) in the Combined Titration and Maintenance Period (T+M) in the ZX008 0.8 mg/kg/Day Group Compared to the Placebo Group	-7.59 percent change
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC-confirmed) in the Combined Titration and Maintenance Period (T+M) in the ZX008 0.8 mg/kg/Day Group Compared to the Placebo Group	-26.49 percent change
Cohort B: Placebo	Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC-confirmed) in the Combined Titration and Maintenance Period (T+M) in the ZX008 0.8 mg/kg/Day Group Compared to the Placebo Group	-17.89 percent change
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC-confirmed) in the Combined Titration and Maintenance Period (T+M) in the ZX008 0.8 mg/kg/Day Group Compared to the Placebo Group	-34.52 percent change

p-value: 0.000895% CI: [-31.02, -8.74]Wilcoxon (Mann-Whitney)

Primary

Part 2: Percentage of Participants With Serious TEAEs

A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose: Results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is medically significant.

Time frame: From Part 2 Baseline until end of the OLE Period (up to 72 months)

Population: The OLE Safety Population included all participants who received at least 1 dose of ZX008 during the OLE. As pre-specified in study design, participants in Part 2 received individualized optimized treatment (0.2 mg/kg/day to 0.8 mg/kg/day) based on Investigator discretion. Hence overall data for Part 2 is reported.

Arm	Measure	Value (NUMBER)
Cohort A: Placebo	Part 2: Percentage of Participants With Serious TEAEs	16.6 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants With Serious TEAEs	18.8 percentage of participants

Primary

Part 2: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

An Adverse event (AE) was defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of investigational product, or whether considered related to the investigational product. A TEAE in Part 2 was defined as any AE with an onset on or after the first dose in Part 2. AEs with onset in Part 1 that are ongoing in Part 2 were not included in the count of AEs in Part 2.

Time frame: From Part 2 Baseline until end of the OLE Period (up to 72 months)

Arm	Measure	Value (NUMBER)
Cohort A: Placebo	Part 2: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	83.0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	96.9 percentage of participants

Secondary

Part 1: Area Under the Concentration-time Curve of Fenfluramine and Norfenfluramine From Time Zero to Time 24 Hours [AUC0-24hours] at Steady State

AUC0-24 is the area under the concentration-time curve from time 0 to 24 hours.

Time frame: At Visit 8 (Day 43) of the Maintenance Period: pre-dose, 1, 2, and 4-6 hours post-dose

Population: The PK analysis set included those participants who received at least one dose of ZX008 and at least one plasma concentration measurement in Study ZX008-1601.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Cohort A: Placebo	Part 1: Area Under the Concentration-time Curve of Fenfluramine and Norfenfluramine From Time Zero to Time 24 Hours [AUC0-24hours] at Steady State	Fenfluramine	246 nanogramshour per milliliter (ngh/mL)	Geometric Coefficient of Variation 63
Cohort A: Placebo	Part 1: Area Under the Concentration-time Curve of Fenfluramine and Norfenfluramine From Time Zero to Time 24 Hours [AUC0-24hours] at Steady State	Norfenfluramine	209 nanogramshour per milliliter (ngh/mL)	Geometric Coefficient of Variation 56.3
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Area Under the Concentration-time Curve of Fenfluramine and Norfenfluramine From Time Zero to Time 24 Hours [AUC0-24hours] at Steady State	Fenfluramine	933 nanogramshour per milliliter (ngh/mL)	Geometric Coefficient of Variation 52.1
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Area Under the Concentration-time Curve of Fenfluramine and Norfenfluramine From Time Zero to Time 24 Hours [AUC0-24hours] at Steady State	Norfenfluramine	667 nanogramshour per milliliter (ngh/mL)	Geometric Coefficient of Variation 55.1

Secondary

Part 1: Change From Baseline in Number of Seizure-free Days During T+M and M Period

A day with no seizures leading to a drop was defined as a day for which electronic (e) diary data were available and no drop seizures were reported. The total number of drop seizure-free days was calculated per 28 days for Baseline and for T+M.

Time frame: From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]; During Maintenance Period (12 weeks), compared to Baseline

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number analyzed included those participants who were evaluable for specified category.

Arm	Measure	Group	Value (MEDIAN)
Cohort A: Placebo	Part 1: Change From Baseline in Number of Seizure-free Days During T+M and M Period	T+M Period	0.27 seizure free days per 28 days
Cohort A: Placebo	Part 1: Change From Baseline in Number of Seizure-free Days During T+M and M Period	M Period	0.31 seizure free days per 28 days
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Change From Baseline in Number of Seizure-free Days During T+M and M Period	T+M Period	0.00 seizure free days per 28 days
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Change From Baseline in Number of Seizure-free Days During T+M and M Period	M Period	0.00 seizure free days per 28 days
Cohort B: Placebo	Part 1: Change From Baseline in Number of Seizure-free Days During T+M and M Period	T+M Period	0.29 seizure free days per 28 days
Cohort B: Placebo	Part 1: Change From Baseline in Number of Seizure-free Days During T+M and M Period	M Period	0.16 seizure free days per 28 days
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Change From Baseline in Number of Seizure-free Days During T+M and M Period	T+M Period	0.00 seizure free days per 28 days
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Change From Baseline in Number of Seizure-free Days During T+M and M Period	M Period	-0.65 seizure free days per 28 days
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Change From Baseline in Number of Seizure-free Days During T+M and M Period	M Period	0.33 seizure free days per 28 days
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Change From Baseline in Number of Seizure-free Days During T+M and M Period	T+M Period	0.38 seizure free days per 28 days
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Change From Baseline in Number of Seizure-free Days During T+M and M Period	T+M Period	6.65 seizure free days per 28 days
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Change From Baseline in Number of Seizure-free Days During T+M and M Period	M Period	7.72 seizure free days per 28 days

Secondary

Part 1: Change From Baseline in the Frequency of All Countable Non-motor Seizures in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo

Countable non-motor seizures included: focal seizures \[FS\] without clear observable signs, myoclonic seizures \[MS\], absence/atypical absence, infantile spasms, epileptic spasms, and other seizures. For each participant, the seizure frequency per 28 days was calculated as the number of seizures recorded during the period, divided by the number of days in the period and multiplied by 28.

Time frame: During Maintenance Period (12 weeks), compared to Baseline

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number of participants analyzed included those participants who were evaluable for the assessment.

Arm	Measure	Value (MEDIAN)
Cohort A: Placebo	Part 1: Change From Baseline in the Frequency of All Countable Non-motor Seizures in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-0.04 seizure frequency per 28 days
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Change From Baseline in the Frequency of All Countable Non-motor Seizures in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-0.13 seizure frequency per 28 days
Cohort B: Placebo	Part 1: Change From Baseline in the Frequency of All Countable Non-motor Seizures in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	0.00 seizure frequency per 28 days
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Change From Baseline in the Frequency of All Countable Non-motor Seizures in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-4.00 seizure frequency per 28 days
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Change From Baseline in the Frequency of All Countable Non-motor Seizures in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	0.00 seizure frequency per 28 days
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Change From Baseline in the Frequency of All Countable Non-motor Seizures in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	0.00 seizure frequency per 28 days

Secondary

Part 1: Change From Baseline in the Frequency of All Countable Non-motor Seizures in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo

Time frame: From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

Arm	Measure	Value (MEDIAN)
Cohort A: Placebo	Part 1: Change From Baseline in the Frequency of All Countable Non-motor Seizures in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	0.00 seizure frequency per 28 days
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Change From Baseline in the Frequency of All Countable Non-motor Seizures in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	0.00 seizure frequency per 28 days
Cohort B: Placebo	Part 1: Change From Baseline in the Frequency of All Countable Non-motor Seizures in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	0.00 seizure frequency per 28 days
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Change From Baseline in the Frequency of All Countable Non-motor Seizures in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-7.16 seizure frequency per 28 days
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Change From Baseline in the Frequency of All Countable Non-motor Seizures in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	0.00 seizure frequency per 28 days
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Change From Baseline in the Frequency of All Countable Non-motor Seizures in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	0.00 seizure frequency per 28 days

Secondary

Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver

CGI-I scale measures improvement in the participant's condition from Baseline. The severity of a participant's condition was rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), as follows: 1-very much improved, 2-much improved, 3-minimally improved, 4- no change, 5-minimally worse, 6-much worse and 7-very much worse.

Time frame: At Days 15, 43, 71 and 99

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number of participants analyzed included those participants who were evaluable for the assessment. Number analyzed included those participants who were evaluable at specified time point.

Arm	Measure	Group	Value (NUMBER)
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D99)	7.4 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D99)	0 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D15)	4.7 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D71)	24.4 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D43)	20.0 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D15)	4.7 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D71)	6.1 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D99)	53.1 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D15)	0 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D71)	0 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D99)	3.7 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D99)	2.5 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D71)	2.4 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D71)	6.1 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D43)	1.2 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D71)	53.7 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D43)	9.4 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D99)	32.1 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D15)	51.8 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D43)	1.2 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D15)	31.8 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D43)	5.9 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D99)	1.2 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D71)	7.3 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D15)	4.7 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D15)	2.4 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D43)	60.0 percentage of participants
Cohort A: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D43)	2.4 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D99)	18.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D71)	4.0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D15)	5.9 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D71)	8.0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D71)	20.0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D99)	7.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D71)	16.0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D71)	48.0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D15)	42.4 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D99)	8.2 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D15)	5.9 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D99)	3.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D15)	3.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D99)	37.6 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D15)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D15)	15.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D99)	16.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D43)	7.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D43)	19.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D43)	18.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D99)	8.2 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D43)	39.0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D43)	11.0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D71)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D43)	4.9 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D15)	27.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D71)	4.0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D43)	0 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D43)	33.8 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D99)	27.5 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D99)	10.0 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D71)	2.7 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D15)	7.4 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D71)	10.7 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D43)	17.5 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D99)	5.0 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D99)	5.0 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D71)	0 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D99)	1.3 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D71)	28.0 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D43)	5.0 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D15)	18.5 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D71)	1.3 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D71)	33.3 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D71)	24.0 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D43)	0 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D15)	21.0 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D99)	23.8 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D43)	13.8 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D43)	5.0 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D43)	25.0 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D15)	9.9 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D99)	27.5 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D15)	1.2 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D15)	2.5 percentage of participants
Cohort B: Placebo	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D15)	39.5 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D71)	63.6 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D15)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D15)	18.2 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D15)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D15)	63.6 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D15)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D15)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D15)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D43)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D43)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D43)	18.2 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D43)	63.6 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D43)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D43)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D43)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D71)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D71)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D71)	18.2 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D71)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D71)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D71)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D99)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D99)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D99)	18.2 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D99)	63.6 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D99)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D99)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D99)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D71)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D43)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D43)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D99)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D71)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D43)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D99)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D71)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D43)	33.3 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D43)	44.4 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D99)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D43)	22.2 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D15)	10.0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D99)	18.2 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D43)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D15)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D99)	27.3 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D15)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D15)	10.0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D99)	45.5 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D15)	20.0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D15)	30.0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D99)	9.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D15)	30.0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D71)	22.2 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D71)	22.2 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D71)	55.6 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D71)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D99)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D71)	11.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D15)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D43)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D15)	27.3 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D99)	36.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D15)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D71)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D43)	20.0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D71)	22.2 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D43)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (D15)	18.2 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D71)	55.6 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D71)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D71)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (D43)	30.0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D99)	27.3 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (D99)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D71)	11.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D99)	18.2 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D43)	40.0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (D15)	27.3 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (D43)	10.0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D15)	18.2 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D99)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (D99)	18.2 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D43)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (D15)	0 percentage of participants

Secondary

Part 1: Duration of Longest Interval (Days) Between Seizures That Result in Drops Comparing the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo

The longest interval between seizures leading to drops were obtained from the eDiary entries in Titration and Maintenance Period. The interval was derived as the maximum value of the number of days between consecutive drop seizures.

Time frame: From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

Arm	Measure	Value (MEDIAN)
Cohort A: Placebo	Part 1: Duration of Longest Interval (Days) Between Seizures That Result in Drops Comparing the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	5.00 days
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Duration of Longest Interval (Days) Between Seizures That Result in Drops Comparing the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	4.00 days
Cohort B: Placebo	Part 1: Duration of Longest Interval (Days) Between Seizures That Result in Drops Comparing the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	5.00 days
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Duration of Longest Interval (Days) Between Seizures That Result in Drops Comparing the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	4.00 days
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Duration of Longest Interval (Days) Between Seizures That Result in Drops Comparing the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	4.00 days
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Duration of Longest Interval (Days) Between Seizures That Result in Drops Comparing the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	6.00 days

Secondary

Part 1: Maximum Observed Plasma Concentration of Fenfluramine and Norfenfluramine Determined Directly From the Concentration Time Profile [Cmax] at Steady State

Cmax is the maximum plasma concentration determined directly from the concentration time profile.

Time frame: At Visit 8 (Day 43) of the Maintenance Period: pre-dose, 1, 2, and 4-6 hours post-dose

Population: The Pharmacokinetic (PK) analysis set included those participants who received at least one dose of ZX008 and at least one plasma concentration measurement in Study ZX008-1601.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Cohort A: Placebo	Part 1: Maximum Observed Plasma Concentration of Fenfluramine and Norfenfluramine Determined Directly From the Concentration Time Profile [Cmax] at Steady State	Fenfluramine	11.9 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 56.1
Cohort A: Placebo	Part 1: Maximum Observed Plasma Concentration of Fenfluramine and Norfenfluramine Determined Directly From the Concentration Time Profile [Cmax] at Steady State	Norfenfluramine	9.04 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 53.4
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Maximum Observed Plasma Concentration of Fenfluramine and Norfenfluramine Determined Directly From the Concentration Time Profile [Cmax] at Steady State	Fenfluramine	44.8 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 47
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Maximum Observed Plasma Concentration of Fenfluramine and Norfenfluramine Determined Directly From the Concentration Time Profile [Cmax] at Steady State	Norfenfluramine	28.9 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 52.9

Secondary

Part 1: Minimum Observed Plasma Concentration of Fenfluramine and Norfenfluramine at Steady State Determined Directly From the Concentration-time Profile [Cmin] at Steady State

Cmin is the minimum plasma concentration determined directly from the concentration-time profile.

Time frame: At Visit 8 (Day 43) of the Maintenance Period: pre-dose, 1, 2, and 4-6 hours post-dose

Population: The PK analysis set included those participants who received at least one dose of ZX008 and at least one plasma concentration measurement in Study ZX008-1601.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Cohort A: Placebo	Part 1: Minimum Observed Plasma Concentration of Fenfluramine and Norfenfluramine at Steady State Determined Directly From the Concentration-time Profile [Cmin] at Steady State	Fenfluramine	8.19 ng/mL	Geometric Coefficient of Variation 75.6
Cohort A: Placebo	Part 1: Minimum Observed Plasma Concentration of Fenfluramine and Norfenfluramine at Steady State Determined Directly From the Concentration-time Profile [Cmin] at Steady State	Norfenfluramine	8.23 ng/mL	Geometric Coefficient of Variation 61.3
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Minimum Observed Plasma Concentration of Fenfluramine and Norfenfluramine at Steady State Determined Directly From the Concentration-time Profile [Cmin] at Steady State	Fenfluramine	31.8 ng/mL	Geometric Coefficient of Variation 60.8
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Minimum Observed Plasma Concentration of Fenfluramine and Norfenfluramine at Steady State Determined Directly From the Concentration-time Profile [Cmin] at Steady State	Norfenfluramine	26.2 ng/mL	Geometric Coefficient of Variation 58.9

Secondary

Part 1: Percentage of Participants Who Achieve a >=50% Reduction From Baseline in the Frequency of Seizures That Result in Drops Comparing the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo

The seizure types included in the count were: atonic, tonic, tonic/atonic, generalized tonic-clonic, and secondarily generalized tonic-clonic seizures resulting in drops. Participants who achieved a \>=50% reduction from Baseline in the DSF, ie, a decrease in DSF of at least 50 percentage points per 28 days during Titration and Maintenance Period.

Time frame: From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

Arm	Measure	Value (NUMBER)
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieve a >=50% Reduction From Baseline in the Frequency of Seizures That Result in Drops Comparing the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	10.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieve a >=50% Reduction From Baseline in the Frequency of Seizures That Result in Drops Comparing the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	28.1 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieve a >=50% Reduction From Baseline in the Frequency of Seizures That Result in Drops Comparing the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	25.3 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieve a >=50% Reduction From Baseline in the Frequency of Seizures That Result in Drops Comparing the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	9.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieve a >=50% Reduction From Baseline in the Frequency of Seizures That Result in Drops Comparing the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	36.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieve a >=50% Reduction From Baseline in the Frequency of Seizures That Result in Drops Comparing the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	36.4 percentage of participants

p-value: 0.005195% CI: [1.43, 7.59]Regression, Logistic

p-value: 0.01595% CI: [1.23, 6.7]Regression, Logistic

Secondary

Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures

Countable motor seizures included: GTC, SGTC; TS, AS, TA, CS, HS, and FS with clearly observable signs. Countable non-motor seizures included: FS without clear observable signs, MS, absence/atypical absence, infantile spasms, epileptic spasms, and other seizures. The participants who experienced a worsening or no change from Baseline (ie \<= 0% reduction); \>0%, \>=25%, \>=50%, \>=75%, and 100% reduction (a 100% reduction was equivalent to achieving seizure freedom during T+M); and near seizure freedom, (defined as 0 or 1 seizure leading to a drop) during combined T+M Period and Maintenance Period were reported.

Time frame: From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]; During Maintenance Period (12 weeks), compared to Baseline

Arm	Measure	Group	Value (NUMBER)
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	> 0% reduction (T+M)	63.2 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Worsening or No Change (T+M)	36.8 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Near Seizure free (M)	0 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 50% reduction (M)	13.8 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Near Seizure free (T+M)	0 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 50% reduction (T+M)	11.5 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	100% reduction (M)	0 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 25% reduction (M)	34.5 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	100% reduction (T+M)	0 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	> 0% reduction (M)	65.5 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 75% reduction (T+M)	3.4 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 75% reduction (M)	3.4 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 25% reduction (T+M)	35.6 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Worsening or No Change (M)	34.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Worsening or No Change (M)	33.0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Near Seizure free (T+M)	1.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	100% reduction (T+M)	1.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	100% reduction (M)	1.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	> 0% reduction (T+M)	67.4 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Worsening or No Change (T+M)	32.6 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 75% reduction (M)	9.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 25% reduction (T+M)	48.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 50% reduction (M)	28.4 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 25% reduction (M)	51.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 50% reduction (T+M)	22.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	> 0% reduction (M)	67.0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 75% reduction (T+M)	6.7 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Near Seizure free (M)	1.1 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 50% reduction (T+M)	20.7 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Worsening or No Change (T+M)	28.7 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	> 0% reduction (T+M)	71.3 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 25% reduction (T+M)	46.0 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 75% reduction (T+M)	4.6 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	100% reduction (T+M)	0 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Near Seizure free (T+M)	0 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Worsening or No Change (M)	27.9 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	> 0% reduction (M)	72.1 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 25% reduction (M)	47.7 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 50% reduction (M)	24.4 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 75% reduction (M)	7.0 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	100% reduction (M)	1.2 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Near Seizure free (M)	1.2 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Worsening or No Change (T+M)	27.3 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 25% reduction (M)	27.3 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	100% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Near Seizure free (M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	100% reduction (M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 25% reduction (T+M)	27.3 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 50% reduction (M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Near Seizure free (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Worsening or No Change (M)	27.3 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	> 0% reduction (M)	72.7 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 75% reduction (T+M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	> 0% reduction (T+M)	72.7 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 50% reduction (T+M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 75% reduction (M)	9.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 75% reduction (T+M)	9.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Worsening or No Change (M)	27.3 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 50% reduction (T+M)	27.3 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Worsening or No Change (T+M)	27.3 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	> 0% reduction (M)	72.7 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 25% reduction (M)	27.3 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 25% reduction (T+M)	27.3 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 50% reduction (M)	27.3 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	> 0% reduction (T+M)	72.7 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 75% reduction (M)	9.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Near Seizure free (M)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	100% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	100% reduction (M)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Near Seizure free (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 75% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 75% reduction (M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	> 0% reduction (M)	72.7 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Worsening or No Change (T+M)	36.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Near Seizure free (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 50% reduction (T+M)	27.3 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	100% reduction (M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Near Seizure free (M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	100% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 50% reduction (M)	27.3 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	> 0% reduction (T+M)	63.6 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	Worsening or No Change (M)	27.3 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 25% reduction (M)	45.5 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures	>= 25% reduction (T+M)	45.5 percentage of participants

Secondary

Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops

The seizure types included in the count were: atonic, tonic, tonic/atonic, generalized tonic-clonic, and secondarily generalized tonic-clonic seizures resulting in drops. The participants who experienced a worsening or no change from Baseline (ie \<= 0% reduction); \>0%, \>=25%, \>=50%, \>=75%, and 100% reduction (a 100% reduction was equivalent to achieving seizure freedom during T+M); and near seizure freedom, (defined as 0 or 1 seizure leading to a drop) during combined T+M Period and Maintenance Period were reported.

Time frame: From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]; During Maintenance Period (12 weeks), compared to Baseline

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, Number Analyzed included those participants who were evaluable at specified time point.

Arm	Measure	Group	Value (NUMBER)
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	100% reduction (M)	1.1 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Worsening or No Change (T+M)	37.9 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Near Seizure free (T+M)	1.1 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Worsening or No Change (M)	40.2 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 75% reduction (T+M)	4.6 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 75% reduction (M)	3.4 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 50% reduction (T+M)	10.3 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	> 0% reduction (T+M)	62.1 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 50% reduction (M)	12.6 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 25% reduction (M)	33.3 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	> 0% reduction (M)	59.8 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	100% reduction (T+M)	1.1 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Near Seizure free (M)	1.1 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 25% reduction (T+M)	31.0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	> 0% reduction (M)	64.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	100% reduction (M)	3.4 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 50% reduction (T+M)	28.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 75% reduction (M)	11.4 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 75% reduction (T+M)	10.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Near Seizure free (T+M)	2.2 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 25% reduction (T+M)	47.2 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Worsening or No Change (T+M)	34.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 50% reduction (M)	31.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Worsening or No Change (M)	35.2 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 25% reduction (M)	46.6 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Near Seizure free (M)	4.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	> 0% reduction (T+M)	65.2 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	100% reduction (T+M)	1.1 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 75% reduction (T+M)	8.0 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Worsening or No Change (M)	20.9 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 75% reduction (M)	14.0 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 50% reduction (M)	31.4 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Near Seizure free (M)	2.3 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Worsening or No Change (T+M)	21.8 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Near Seizure free (T+M)	1.1 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	> 0% reduction (T+M)	78.2 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 25% reduction (T+M)	51.7 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 50% reduction (T+M)	25.3 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	100% reduction (M)	2.3 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 25% reduction (M)	53.5 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	100% reduction (T+M)	0 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	> 0% reduction (M)	79.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 75% reduction (T+M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	100% reduction (M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 25% reduction (T+M)	36.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Near Seizure free (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	> 0% reduction (T+M)	63.6 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 50% reduction (M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	100% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Worsening or No Change (T+M)	36.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 25% reduction (M)	36.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	> 0% reduction (M)	63.6 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Worsening or No Change (M)	36.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Near Seizure free (M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 50% reduction (T+M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 75% reduction (M)	9.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	> 0% reduction (M)	72.7 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Near Seizure free (T+M)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Worsening or No Change (M)	27.3 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Worsening or No Change (T+M)	27.3 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	> 0% reduction (T+M)	72.7 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 25% reduction (T+M)	36.4 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 50% reduction (T+M)	36.4 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 75% reduction (T+M)	9.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	100% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 25% reduction (M)	36.4 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 50% reduction (M)	36.4 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 75% reduction (M)	9.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	100% reduction (M)	9.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Near Seizure free (M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Near Seizure free (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 75% reduction (M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	100% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 75% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 50% reduction (T+M)	36.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 25% reduction (T+M)	63.6 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Near Seizure free (M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	100% reduction (M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	> 0% reduction (T+M)	90.9 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Worsening or No Change (T+M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	Worsening or No Change (M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 50% reduction (M)	36.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	>= 25% reduction (M)	72.7 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops	> 0% reduction (M)	90.9 percentage of participants

Secondary

Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures

Countable motor seizures included: GTC, SGTC, TS, AS, TA, CS, HS, and FS with clearly observable signs. The participants who experienced a worsening or no change from Baseline (ie \<= 0% reduction); \>0%, \>=25%, \>=50%, \>=75%, and 100% reduction (a 100% reduction was equivalent to achieving seizure freedom during T+M); and near seizure freedom, (defined as 0 or 1 seizure leading to a drop) during combined T+M Period and Maintenance Period were reported.

Time frame: From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]; During Maintenance Period (12 weeks), compared to Baseline

Arm	Measure	Group	Value (NUMBER)
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Near Seizure free (T+M)	0 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	100% reduction (M)	0 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 50% reduction (M)	10.3 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	> 0% reduction (T+M)	65.5 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 50% reduction (T+M)	9.2 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 75% reduction (M)	1.1 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Worsening or No Change (T+M)	34.5 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 25% reduction (M)	34.5 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 25% reduction (T+M)	33.3 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	> 0% reduction (M)	63.2 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 75% reduction (T+M)	2.3 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	100% reduction (T+M)	0 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Near Seizure free (M)	0 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Worsening or No Change (M)	36.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Worsening or No Change (M)	38.6 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Near Seizure free (T+M)	1.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	100% reduction (T+M)	1.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	100% reduction (M)	2.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	> 0% reduction (T+M)	61.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Worsening or No Change (T+M)	38.2 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 75% reduction (M)	11.4 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 25% reduction (T+M)	44.9 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Near Seizure free (M)	2.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 50% reduction (M)	28.4 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 25% reduction (M)	45.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 50% reduction (T+M)	24.7 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	> 0% reduction (M)	61.4 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 75% reduction (T+M)	9.0 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 50% reduction (T+M)	25.3 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Worsening or No Change (T+M)	20.7 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	> 0% reduction (T+M)	79.3 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 25% reduction (T+M)	50.6 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 75% reduction (T+M)	6.9 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	100% reduction (T+M)	0 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Near Seizure free (T+M)	0 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Worsening or No Change (M)	18.6 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	> 0% reduction (M)	81.4 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 25% reduction (M)	53.5 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 50% reduction (M)	26.7 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 75% reduction (M)	10.5 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	100% reduction (M)	1.2 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Near Seizure free (M)	1.2 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Worsening or No Change (T+M)	36.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 25% reduction (M)	36.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	100% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Near Seizure free (M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	100% reduction (M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 25% reduction (T+M)	36.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 50% reduction (M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Near Seizure free (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Worsening or No Change (M)	36.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	> 0% reduction (M)	63.6 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 75% reduction (T+M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	> 0% reduction (T+M)	63.6 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 50% reduction (T+M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 75% reduction (M)	9.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 75% reduction (T+M)	9.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Worsening or No Change (M)	27.3 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 50% reduction (T+M)	36.4 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Worsening or No Change (T+M)	27.3 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	> 0% reduction (M)	72.7 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 25% reduction (M)	36.4 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 25% reduction (T+M)	36.4 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 50% reduction (M)	36.4 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	> 0% reduction (T+M)	72.7 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 75% reduction (M)	9.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Near Seizure free (M)	9.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	100% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	100% reduction (M)	9.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Near Seizure free (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 75% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 75% reduction (M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	> 0% reduction (M)	90.9 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Worsening or No Change (T+M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Near Seizure free (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 50% reduction (T+M)	36.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	100% reduction (M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Near Seizure free (M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	100% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 50% reduction (M)	36.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	> 0% reduction (T+M)	90.9 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	Worsening or No Change (M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 25% reduction (M)	72.7 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures	>= 25% reduction (T+M)	63.6 percentage of participants

Secondary

Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures

Countable non-motor seizures include: FS without clear observable signs, MS, absence/atypical absence, infantile spasms, epileptic spasms, and other seizures. The participants who experienced a worsening or no change from Baseline (ie \<= 0% reduction); \>0%, \>=25%, \>=50%, \>=75%, and 100% reduction (a 100% reduction was equivalent to achieving seizure freedom during T+M); and near seizure freedom, (defined as 0 or 1 seizure leading to a drop) during combined T+M Period and Maintenance Period were reported.

Time frame: From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]; During Maintenance Period (12 weeks), compared to Baseline

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number of participants analyzed included those participants who were evaluable for the assessment. Number analyzed included those participants who were evaluable at specified time point.

Arm	Measure	Group	Value (NUMBER)
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Near Seizure free (T+M)	3.2 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	100% reduction (M)	6.3 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 50% reduction (M)	34.9 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	> 0% reduction (T+M)	66.7 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 50% reduction (T+M)	30.2 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 75% reduction (M)	17.5 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Worsening or No Change (T+M)	33.3 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 25% reduction (M)	54.0 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 25% reduction (T+M)	52.4 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	> 0% reduction (M)	69.8 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 75% reduction (T+M)	14.3 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	100% reduction (T+M)	3.2 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Near Seizure free (M)	7.9 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Worsening or No Change (M)	30.2 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Worsening or No Change (M)	30.2 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Near Seizure free (T+M)	14.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	100% reduction (T+M)	6.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	100% reduction (M)	9.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	> 0% reduction (T+M)	65.6 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Worsening or No Change (T+M)	34.4 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 75% reduction (M)	31.7 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 25% reduction (T+M)	56.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Near Seizure free (M)	15.9 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 50% reduction (M)	49.2 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 25% reduction (M)	60.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 50% reduction (T+M)	48.4 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	> 0% reduction (M)	69.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 75% reduction (T+M)	32.8 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 50% reduction (T+M)	35.1 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Worsening or No Change (T+M)	36.8 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	> 0% reduction (T+M)	63.2 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 25% reduction (T+M)	43.9 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 75% reduction (T+M)	12.3 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	100% reduction (T+M)	3.5 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Near Seizure free (T+M)	5.3 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Worsening or No Change (M)	33.9 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	> 0% reduction (M)	66.1 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 25% reduction (M)	48.2 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 50% reduction (M)	33.9 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 75% reduction (M)	17.9 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	100% reduction (M)	8.9 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Near Seizure free (M)	10.7 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Worsening or No Change (T+M)	25.0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 25% reduction (M)	50.0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	100% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Near Seizure free (M)	12.5 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	100% reduction (M)	12.5 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 25% reduction (T+M)	50.0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 50% reduction (M)	25.0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Near Seizure free (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Worsening or No Change (M)	12.5 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	> 0% reduction (M)	87.5 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 75% reduction (T+M)	12.5 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	> 0% reduction (T+M)	75.0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 50% reduction (T+M)	25.0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 75% reduction (M)	12.5 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 75% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Worsening or No Change (M)	57.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 50% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Worsening or No Change (T+M)	57.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	> 0% reduction (M)	42.9 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 25% reduction (M)	14.3 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 25% reduction (T+M)	14.3 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 50% reduction (M)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	> 0% reduction (T+M)	42.9 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 75% reduction (M)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Near Seizure free (M)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	100% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	100% reduction (M)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Near Seizure free (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 75% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 75% reduction (M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	> 0% reduction (M)	62.5 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Worsening or No Change (T+M)	37.5 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Near Seizure free (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 50% reduction (T+M)	25.0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	100% reduction (M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Near Seizure free (M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	100% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 50% reduction (M)	37.5 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	> 0% reduction (T+M)	62.5 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	Worsening or No Change (M)	37.5 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 25% reduction (M)	37.5 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures	>= 25% reduction (T+M)	37.5 percentage of participants

Secondary

Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops

Countable motor seizures included: GTC, SGTC; TS, AS, TA, CS, HS, FS with clearly observable signs. The participants who experienced a worsening or no change from Baseline (ie \<= 0% reduction); \>0%, \>=25%, \>=50%, \>=75%, and 100% reduction (a 100% reduction was equivalent to achieving seizure freedom during T+M); and near seizure freedom, (defined as 0 or 1 seizure leading to a drop) during combined T+M Period and Maintenance Period were reported.

Time frame: From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]; During Maintenance Period (12 weeks), compared to Baseline

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number of participants analyzed included those participants who were evaluable for the assessment. Number analyzed included those participants who were evaluable at specified time point.

Arm	Measure	Group	Value (NUMBER)
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Near Seizure free (T+M)	2.9 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	100% reduction (M)	5.7 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 50% reduction (M)	31.4 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	> 0% reduction (T+M)	64.3 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 50% reduction (T+M)	30.0 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 75% reduction (M)	17.1 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Worsening or No Change (T+M)	35.7 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 25% reduction (M)	54.3 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 25% reduction (T+M)	51.4 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	> 0% reduction (M)	68.6 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 75% reduction (T+M)	12.9 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	100% reduction (T+M)	2.9 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Near Seizure free (M)	7.1 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Worsening or No Change (M)	31.4 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Worsening or No Change (M)	33.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Near Seizure free (T+M)	9.6 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	100% reduction (T+M)	5.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	100% reduction (M)	9.7 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	> 0% reduction (T+M)	65.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Worsening or No Change (T+M)	34.2 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 75% reduction (M)	29.2 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 25% reduction (T+M)	53.4 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Near Seizure free (M)	13.9 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 50% reduction (M)	44.4 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 25% reduction (M)	56.9 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 50% reduction (T+M)	43.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	> 0% reduction (M)	66.7 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 75% reduction (T+M)	26.0 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 50% reduction (T+M)	32.8 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Worsening or No Change (T+M)	34.4 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	> 0% reduction (T+M)	65.6 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 25% reduction (T+M)	46.9 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 75% reduction (T+M)	12.5 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	100% reduction (T+M)	4.7 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Near Seizure free (T+M)	7.8 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Worsening or No Change (M)	34.9 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	> 0% reduction (M)	65.1 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 25% reduction (M)	49.2 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 50% reduction (M)	33.3 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 75% reduction (M)	17.5 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	100% reduction (M)	6.3 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Near Seizure free (M)	9.5 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Worsening or No Change (T+M)	25.0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 25% reduction (M)	50.0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	100% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Near Seizure free (M)	12.5 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	100% reduction (M)	12.5 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 25% reduction (T+M)	50.0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 50% reduction (M)	25.0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Near Seizure free (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Worsening or No Change (M)	25.0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	> 0% reduction (M)	75.0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 75% reduction (T+M)	12.5 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	> 0% reduction (T+M)	75.0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 50% reduction (T+M)	25.0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 75% reduction (M)	12.5 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 75% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Worsening or No Change (M)	57.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 50% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Worsening or No Change (T+M)	57.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	> 0% reduction (M)	42.9 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 25% reduction (M)	14.3 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 25% reduction (T+M)	14.3 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 50% reduction (M)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	> 0% reduction (T+M)	42.9 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 75% reduction (M)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Near Seizure free (M)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	100% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	100% reduction (M)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Near Seizure free (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 75% reduction (T+M)	11.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 75% reduction (M)	11.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	> 0% reduction (M)	55.6 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Worsening or No Change (T+M)	44.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Near Seizure free (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 50% reduction (T+M)	22.2 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	100% reduction (M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Near Seizure free (M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	100% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 50% reduction (M)	22.2 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	> 0% reduction (T+M)	55.6 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	Worsening or No Change (M)	44.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 25% reduction (M)	44.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops	>= 25% reduction (T+M)	44.4 percentage of participants

Secondary

Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops

Seizures that typically result in drops included all: GTC, SGTC, TS, AS, and TA, whether confirmed by the ESC or not. The participants who experienced a worsening or no change from Baseline (ie \<= 0% reduction); \>0%, \>=25%, \>=50%, \>=75%, and 100% reduction (a 100% reduction was equivalent to achieving seizure freedom during T+M); and near seizure freedom, (defined as 0 or 1 seizure leading to a drop) during combined T+M Period and Maintenance Period were reported.

Time frame: From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]; During Maintenance Period (12 weeks), compared to Baseline

Arm	Measure	Group	Value (NUMBER)
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Near Seizure free (T+M)	1.1 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	100% reduction (M)	1.1 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 50% reduction (M)	10.3 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	> 0% reduction (T+M)	64.4 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 50% reduction (T+M)	9.2 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 75% reduction (M)	2.3 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Worsening or No Change (T+M)	35.6 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 25% reduction (M)	33.3 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 25% reduction (T+M)	31.0 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	> 0% reduction (M)	62.1 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 75% reduction (T+M)	3.4 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	100% reduction (T+M)	1.1 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Near Seizure free (M)	1.1 percentage of participants
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Worsening or No Change (M)	37.9 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Worsening or No Change (M)	37.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Near Seizure free (T+M)	1.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	100% reduction (T+M)	1.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	100% reduction (M)	2.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	> 0% reduction (T+M)	64.0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Worsening or No Change (T+M)	36.0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 75% reduction (M)	10.2 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 25% reduction (T+M)	46.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Near Seizure free (M)	2.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 50% reduction (M)	30.7 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 25% reduction (M)	45.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 50% reduction (T+M)	27.0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	> 0% reduction (M)	62.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 75% reduction (T+M)	9.0 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 50% reduction (T+M)	26.4 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Worsening or No Change (T+M)	20.7 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	> 0% reduction (T+M)	79.3 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 25% reduction (T+M)	50.6 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 75% reduction (T+M)	8.0 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	100% reduction (T+M)	0 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Near Seizure free (T+M)	1.1 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Worsening or No Change (M)	19.8 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	> 0% reduction (M)	80.2 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 25% reduction (M)	52.3 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 50% reduction (M)	31.4 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 75% reduction (M)	12.8 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	100% reduction (M)	2.3 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Near Seizure free (M)	2.3 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Worsening or No Change (T+M)	36.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 25% reduction (M)	36.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	100% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Near Seizure free (M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	100% reduction (M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 25% reduction (T+M)	36.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 50% reduction (M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Near Seizure free (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Worsening or No Change (M)	36.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	> 0% reduction (M)	63.6 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 75% reduction (T+M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	> 0% reduction (T+M)	63.6 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 50% reduction (T+M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 75% reduction (M)	9.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 75% reduction (T+M)	9.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Worsening or No Change (M)	27.3 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 50% reduction (T+M)	36.4 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Worsening or No Change (T+M)	27.3 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	> 0% reduction (M)	72.7 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 25% reduction (M)	36.4 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 25% reduction (T+M)	36.4 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 50% reduction (M)	36.4 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	> 0% reduction (T+M)	72.7 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 75% reduction (M)	9.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Near Seizure free (M)	9.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	100% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	100% reduction (M)	9.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Near Seizure free (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 75% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 75% reduction (M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	> 0% reduction (M)	90.9 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Worsening or No Change (T+M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Near Seizure free (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 50% reduction (T+M)	36.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	100% reduction (M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Near Seizure free (M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	100% reduction (T+M)	0 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 50% reduction (M)	36.4 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	> 0% reduction (T+M)	90.9 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	Worsening or No Change (M)	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 25% reduction (M)	72.7 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops	>= 25% reduction (T+M)	63.6 percentage of participants

Secondary

Part 1: Percentage of Participants Who Achieve Improvement (Minimally, Much or Very Much Improved) in the CGI-I Scale as Assessed by Principal Investigator Comparing ZX008 0.8 and 0.2 mg/kg/Day Groups Independently Versus Placebo

Clinical Global Impression - Improvement (CGI-I) scale measures improvement in the participant's condition from Baseline. The severity of a participant's condition was rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), as follows: 1-very much improved,2-much improved, 3-minimally improved, 4- no change, 5-minimally worse, 6-much worse and 7-very much worse.

Time frame: At Day 99 (Visit 12)

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number of participants analyzed included those participants who were evaluable for the assessment.

Arm	Measure	Value (NUMBER)
Cohort A: Placebo	Part 1: Percentage of Participants Who Achieve Improvement (Minimally, Much or Very Much Improved) in the CGI-I Scale as Assessed by Principal Investigator Comparing ZX008 0.8 and 0.2 mg/kg/Day Groups Independently Versus Placebo	33.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieve Improvement (Minimally, Much or Very Much Improved) in the CGI-I Scale as Assessed by Principal Investigator Comparing ZX008 0.8 and 0.2 mg/kg/Day Groups Independently Versus Placebo	44.7 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants Who Achieve Improvement (Minimally, Much or Very Much Improved) in the CGI-I Scale as Assessed by Principal Investigator Comparing ZX008 0.8 and 0.2 mg/kg/Day Groups Independently Versus Placebo	48.8 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieve Improvement (Minimally, Much or Very Much Improved) in the CGI-I Scale as Assessed by Principal Investigator Comparing ZX008 0.8 and 0.2 mg/kg/Day Groups Independently Versus Placebo	9.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants Who Achieve Improvement (Minimally, Much or Very Much Improved) in the CGI-I Scale as Assessed by Principal Investigator Comparing ZX008 0.8 and 0.2 mg/kg/Day Groups Independently Versus Placebo	45.5 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants Who Achieve Improvement (Minimally, Much or Very Much Improved) in the CGI-I Scale as Assessed by Principal Investigator Comparing ZX008 0.8 and 0.2 mg/kg/Day Groups Independently Versus Placebo	72.7 percentage of participants

Comparison: Visit 12p-value: 0.156595% CI: [0.84, 2.97]Cochran-Mantel-Haenszel

Comparison: Visit 12p-value: 0.056795% CI: [0.98, 3.52]Cochran-Mantel-Haenszel

Secondary

Part 1: Percentage of Participants With Serious TEAEs

Time frame: Baseline up to 14 weeks + Taper/Transition (2 weeks)

Population: The Safety Population included all randomized participants who received at least 1 dose of study drug.

Arm	Measure	Value (NUMBER)
Cohort A: Placebo	Part 1: Percentage of Participants With Serious TEAEs	4.6 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants With Serious TEAEs	4.5 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants With Serious TEAEs	11.5 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants With Serious TEAEs	9.1 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants With Serious TEAEs	9.1 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants With Serious TEAEs	0 percentage of participants

Secondary

Part 1: Percentage of Participants With TEAEs

Adverse events were defined as any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A TEAE in Part 1 was defined as any AE that, based on start date information, occurred after the first dose of study drug in Part 1, but not on or after the first dose of study drug in Part 2.

Time frame: Baseline up to 14 weeks + Taper/Transition (2 weeks)

Population: The Safety Population included all randomized participants who received at least 1 dose of study drug.

Arm	Measure	Value (NUMBER)
Cohort A: Placebo	Part 1: Percentage of Participants With TEAEs	80.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants With TEAEs	78.7 percentage of participants
Cohort B: Placebo	Part 1: Percentage of Participants With TEAEs	89.7 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants With TEAEs	72.7 percentage of participants
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percentage of Participants With TEAEs	90.9 percentage of participants
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percentage of Participants With TEAEs	63.6 percentage of participants

Secondary

Part 1: Percent Change From Baseline in Frequency of All Seizures That Typically Result in Drops in T+M, Whether ESC-confirmed as Drop or Not in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo

Seizures that typically result in drops included all: generalized tonic-clonic seizures \[GTC\], secondarily generalized tonic-clonic \[SGTC\], tonic seizures \[TS\], atonic seizures \[AS\], and tonic/atonic seizures \[TA\], whether confirmed by the ESC or not. Seizures that result in a drop were defined as seizures involving the entire body, trunk, or head that led to a fall, injury, slumping in a chair, or the participant's head hitting a surface or that could have led to a fall or injury, depending on the patient's position at the time of the seizure.

Time frame: From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

Arm	Measure	Value (MEDIAN)
Cohort A: Placebo	Part 1: Percent Change From Baseline in Frequency of All Seizures That Typically Result in Drops in T+M, Whether ESC-confirmed as Drop or Not in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-8.43 percent change
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in Frequency of All Seizures That Typically Result in Drops in T+M, Whether ESC-confirmed as Drop or Not in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-11.75 percent change
Cohort B: Placebo	Part 1: Percent Change From Baseline in Frequency of All Seizures That Typically Result in Drops in T+M, Whether ESC-confirmed as Drop or Not in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-26.28 percent change
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in Frequency of All Seizures That Typically Result in Drops in T+M, Whether ESC-confirmed as Drop or Not in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-17.89 percent change
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percent Change From Baseline in Frequency of All Seizures That Typically Result in Drops in T+M, Whether ESC-confirmed as Drop or Not in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-14.12 percent change
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in Frequency of All Seizures That Typically Result in Drops in T+M, Whether ESC-confirmed as Drop or Not in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-34.04 percent change

Secondary

Part 1: Percent Change From Baseline in Frequency of Countable Seizures That do Not Result in Drops (ESC Confirmed)

Non-drop seizures were defined as any countable seizure types that did not meet the criteria of drop seizures, ie, are classified as CS, HC, FS with or without observable signs, MS, absence/atypical absence, infantile spasms, epileptic spasms, or other; or are seizures of the following classifications that were approved for each participant as non-drop seizure types by the ESC: GTC, SGTC, TS, AS, or TA.

Time frame: From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number of participants analyzed included those participants who were evaluable for the assessment.

Arm	Measure	Value (MEDIAN)
Cohort A: Placebo	Part 1: Percent Change From Baseline in Frequency of Countable Seizures That do Not Result in Drops (ESC Confirmed)	-26.92 percent change
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in Frequency of Countable Seizures That do Not Result in Drops (ESC Confirmed)	-31.32 percent change
Cohort B: Placebo	Part 1: Percent Change From Baseline in Frequency of Countable Seizures That do Not Result in Drops (ESC Confirmed)	-22.68 percent change
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in Frequency of Countable Seizures That do Not Result in Drops (ESC Confirmed)	-23.38 percent change
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percent Change From Baseline in Frequency of Countable Seizures That do Not Result in Drops (ESC Confirmed)	0.27 percent change
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in Frequency of Countable Seizures That do Not Result in Drops (ESC Confirmed)	-22.99 percent change

Secondary

Part 1: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo

Countable motor seizures included: GTC, SGTC,TS, AS, TA, CS, HS, and FS with clearly observable signs.

Time frame: During Maintenance Period (12 weeks), compared to Baseline

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number of participants analyzed included those participants who were evaluable for the assessment.

Arm	Measure	Value (MEDIAN)
Cohort A: Placebo	Part 1: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-10.21 percent change
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-17.30 percent change
Cohort B: Placebo	Part 1: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-28.33 percent change
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-18.18 percent change
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-12.88 percent change
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-46.88 percent change

Secondary

Part 1: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo

Countable motor seizures included: GTC, SGTC, TS, AS, TA, clonic seizures \[CS\], hemiclonic seizures \[HS\], and focal seizures \[FS\] with clearly observable signs.

Time frame: From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

Arm	Measure	Value (MEDIAN)
Cohort A: Placebo	Part 1: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-8.43 percent change
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-11.75 percent change
Cohort B: Placebo	Part 1: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-26.28 percent change
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-17.89 percent change
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-14.12 percent change
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-34.04 percent change

Secondary

Part 1: Percent Change From Baseline in the Frequency of All Countable Seizures (Motor and Non-motor) in the Maintenance Period in ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo

Countable motor seizures included: GTC, SGTC, TS, AS, TA, CS, HS, and FS with clearly observable signs. Countable non-motor seizures included: FS without clear observable signs, MS, absence/atypical absence, infantile spasms, epileptic spasms, and other seizures.

Time frame: During Maintenance Period (12 weeks), compared to Baseline

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number of participants analyzed included those participants who were evaluable for the assessment.

Arm	Measure	Value (MEDIAN)
Cohort A: Placebo	Part 1: Percent Change From Baseline in the Frequency of All Countable Seizures (Motor and Non-motor) in the Maintenance Period in ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-9.49 percent change
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of All Countable Seizures (Motor and Non-motor) in the Maintenance Period in ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-27.63 percent change
Cohort B: Placebo	Part 1: Percent Change From Baseline in the Frequency of All Countable Seizures (Motor and Non-motor) in the Maintenance Period in ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-23.34 percent change
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of All Countable Seizures (Motor and Non-motor) in the Maintenance Period in ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-18.18 percent change
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of All Countable Seizures (Motor and Non-motor) in the Maintenance Period in ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-20.33 percent change
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of All Countable Seizures (Motor and Non-motor) in the Maintenance Period in ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-17.68 percent change

Secondary

Part 1: Percent Change From Baseline in the Frequency of All Countable Seizures (Motor and Non-motor) in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo

Time frame: From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

Arm	Measure	Value (MEDIAN)
Cohort A: Placebo	Part 1: Percent Change From Baseline in the Frequency of All Countable Seizures (Motor and Non-motor) in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-9.40 percent change
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of All Countable Seizures (Motor and Non-motor) in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-23.55 percent change
Cohort B: Placebo	Part 1: Percent Change From Baseline in the Frequency of All Countable Seizures (Motor and Non-motor) in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-21.70 percent change
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of All Countable Seizures (Motor and Non-motor) in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-17.69 percent change
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of All Countable Seizures (Motor and Non-motor) in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-20.41 percent change
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of All Countable Seizures (Motor and Non-motor) in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-13.85 percent change

Secondary

Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC Confirmed) Between Baseline and the Maintenance Period

The frequency of drop seizures during a given interval was derived from the number and type of events recorded in participant electronic diaries. The seizure types included in the count were: atonic, tonic, tonic/atonic, generalized tonic-clonic, and secondarily generalized tonic-clonic seizures resulting in drops.

Time frame: During Maintenance Period (12 weeks), compared to Baseline

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number of participants analyzed included those participants who were evaluable for the assessment.

Arm	Measure	Value (MEDIAN)
Cohort A: Placebo	Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC Confirmed) Between Baseline and the Maintenance Period	-7.28 percent change
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC Confirmed) Between Baseline and the Maintenance Period	-18.63 percent change
Cohort B: Placebo	Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC Confirmed) Between Baseline and the Maintenance Period	-27.16 percent change
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC Confirmed) Between Baseline and the Maintenance Period	-18.18 percent change
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC Confirmed) Between Baseline and the Maintenance Period	-12.88 percent change
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC Confirmed) Between Baseline and the Maintenance Period	-45.07 percent change

Secondary

Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC-confirmed) in T+M in the ZX008 0.2 mg/kg/Day Group Compared to the Placebo Group

Time frame: From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

Arm	Measure	Value (MEDIAN)
Cohort A: Placebo	Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC-confirmed) in T+M in the ZX008 0.2 mg/kg/Day Group Compared to the Placebo Group	-7.59 percent change
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC-confirmed) in T+M in the ZX008 0.2 mg/kg/Day Group Compared to the Placebo Group	-14.16 percent change
Cohort B: Placebo	Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC-confirmed) in T+M in the ZX008 0.2 mg/kg/Day Group Compared to the Placebo Group	-17.89 percent change
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC-confirmed) in T+M in the ZX008 0.2 mg/kg/Day Group Compared to the Placebo Group	-14.12 percent change

p-value: 0.14695% CI: [-24.99, 3.99]Wilcoxon (Mann-Whitney)

Secondary

Part 1: Percent Change From Baseline in the Frequency of Seizures That Typically Result in Drops in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo

Seizures that typically result in drops included all: GTC, SGTC, TS, AS, and TA, whether confirmed by the ESC or not.

Time frame: During Maintenance Period (12 weeks), compared to Baseline

Population: The mITT Population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number of participants analyzed included those participants who were evaluable for the assessment.

Arm	Measure	Value (MEDIAN)
Cohort A: Placebo	Part 1: Percent Change From Baseline in the Frequency of Seizures That Typically Result in Drops in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-9.37 percent change
Cohort A: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of Seizures That Typically Result in Drops in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-17.30 percent change
Cohort B: Placebo	Part 1: Percent Change From Baseline in the Frequency of Seizures That Typically Result in Drops in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-26.30 percent change
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of Seizures That Typically Result in Drops in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-18.18 percent change
Cohort B: ZX008 0.2 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of Seizures That Typically Result in Drops in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-12.88 percent change
Cohort B: ZX008 0.8 mg/kg/Day	Part 1: Percent Change From Baseline in the Frequency of Seizures That Typically Result in Drops in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo	-46.88 percent change

Secondary

Part 2: Change From Baseline in Duration of Longest Interval Between Seizures That Result in Drops (ESC Confirmed) in OLE Period

The longest interval between seizures leading to drops were obtained from the eDiary entries in OLE Period. The interval was derived as the maximum value of the number of days between consecutive drop seizures.

Time frame: From Part 2 Baseline until end of the OLE Period (up to 72 months)

Population: OLE mITT:all participants who received at least 1 dose of ZX008 and had valid estimate of frequency of seizures that resulted in drops from Part 1 and at least 1 month(30 days) of valid seizure data during OLE. Number of participants analyzed=participants who were evaluable for assessment. As pre-specified in study design, participants in Part 2 received individualized optimized treatment(0.2 mg/kg/day to 0.8 mg/kg/day) based on Investigator discretion. Hence overall data for Part 2 is reported.

Arm	Measure	Value (MEDIAN)
Cohort A: Placebo	Part 2: Change From Baseline in Duration of Longest Interval Between Seizures That Result in Drops (ESC Confirmed) in OLE Period	4.0 days
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Change From Baseline in Duration of Longest Interval Between Seizures That Result in Drops (ESC Confirmed) in OLE Period	6.0 days

Secondary

Part 2: Change From Baseline in Number of Seizure-free Days Per 28 Days (ESC Confirmed) in OLE Period

A day with no seizures leading to a drop was defined as a day for which ediary data were available and no drop seizures were reported.

Time frame: From Part 2 Baseline until end of OLE Period (up to 72 months)

Population: The OLE mITT population included all participants who received at least 1 dose of ZX008 and had a valid estimate of the frequency of seizures that resulted in drops from Part 1 and at least 1 month (30 days) of valid seizure data during the OLE. As pre-specified in study design, participants in Part 2 received individualized optimized treatment (0.2 mg/kg/day to 0.8 mg/kg/day) based on Investigator discretion. Hence overall data for Part 2 is reported.

Arm	Measure	Value (MEDIAN)
Cohort A: Placebo	Part 2: Change From Baseline in Number of Seizure-free Days Per 28 Days (ESC Confirmed) in OLE Period	2.16 seizure free days per 28 days
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Change From Baseline in Number of Seizure-free Days Per 28 Days (ESC Confirmed) in OLE Period	4.24 seizure free days per 28 days

Secondary

Part 2: Change From Baseline in the Frequency of All Countable Non-motor Seizures in OLE Period

Time frame: From OLE Month 1 to Month12, compared to Baseline (Part 1)

Arm	Measure	Value (MEDIAN)
Cohort A: Placebo	Part 2: Change From Baseline in the Frequency of All Countable Non-motor Seizures in OLE Period	0.00 seizure frequency per 28 days
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Change From Baseline in the Frequency of All Countable Non-motor Seizures in OLE Period	0.00 seizure frequency per 28 days

Secondary

Part 2: Change From Baseline in the Frequency of All Countable Seizures That Did Not Result in Drops (ESC Confirmed) in OLE Period

Nondrop seizures were defined as any countable seizure types that did not meet the criteria of drop seizures, ie, are classified as CS, HC, FS with or without observable signs, MS, absence/atypical absence, infantile spasms, epileptic spasms, or other; or are seizures of the following classifications that were approved for each subject as non-drop seizure types by the ESC: GTC, SGTC, TS, AS, or TA. For each participant, the seizure frequency per 28 days was calculated as the number of seizures recorded during the period, divided by the number of days in the period and multiplied by 28.

Time frame: From OLE Month 1 to Month12, compared to Baseline (Part 1)

Arm	Measure	Value (MEDIAN)
Cohort A: Placebo	Part 2: Change From Baseline in the Frequency of All Countable Seizures That Did Not Result in Drops (ESC Confirmed) in OLE Period	-0.99 seizure frequency per 28 days
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Change From Baseline in the Frequency of All Countable Seizures That Did Not Result in Drops (ESC Confirmed) in OLE Period	0.00 seizure frequency per 28 days

Secondary

Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver

CGI-I scale measures improvement in the participant's condition from Baseline. The severity of a participant's condition was rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), as follows: 1-very much improved,2-much improved, 3-minimally improved, 4- no change, 5-minimally worse, 6-much worse and 7-very much worse.

Time frame: At OLE Day 1, OLE Months (M) 1, 2, 3, 6, 9, 12, and Last Assessment (up to 72 months)

Population: OLE mITT:all participants who received \>= 1 dose of ZX008, had valid estimate of frequency of seizures that resulted in drops from Part 1 and \>= 1 month(30 days) of valid seizure data during OLE. N: participants evaluable for assessment. n: participants evaluable at specified time point. As pre-specified in study design, participants in Part 2 received individualized optimized treatment (0.2 mg/kg/day to 0.8 mg/kg/day) based on Investigator discretion. Hence overall data for Part 2 is reported.

Arm	Measure	Group	Value (NUMBER)
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (OLE D1)	6.9 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (OLE D1)	16.8 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (OLE D1)	24.6 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (OLE D1)	40.1 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (OLE D1)	6.9 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (OLE D1)	3.9 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (OLE D1)	0.9 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (OLE M1)	7.1 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (OLE M1)	21.4 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (OLE M1)	32.1 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (OLE M1)	29.5 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (Last Assessment)	9.3 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (OLE M1)	5.8 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (Last Assessment)	3.4 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (Last Assessment)	2.1 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (OLE M1)	4.0 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (OLE M1)	0 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (OLE M2)	7.3 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (OLE M2)	25.6 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (OLE M2)	32.0 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (OLE M2)	25.6 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (OLE M2)	6.4 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (OLE M2)	2.3 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (OLE M2)	0.9 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (OLE M3)	9.7 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (OLE M3)	30.0 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (OLE M3)	29.5 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (OLE M3)	19.3 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (OLE M3)	9.7 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (OLE M3)	0.5 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (OLE M3)	1.4 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (OLE M6)	13.4 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (OLE M6)	30.1 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (OLE M6)	27.4 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (OLE M6)	23.1 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (OLE M6)	3.2 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (OLE M6)	2.2 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (OLE M6)	0.5 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (OLE M9)	13.4 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (OLE M9)	37.3 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (OLE M9)	26.1 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (OLE M9)	14.2 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (OLE M9)	8.2 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (OLE M9)	0.7 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (OLE M9)	0 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (OLE M12)	16.8 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (OLE M12)	34.2 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (OLE M12)	26.8 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (OLE M12)	14.8 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (OLE M12)	4.7 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (OLE M12)	2.0 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (OLE M12)	0.7 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (Last Assessment)	11.4 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (Last Assessment)	24.1 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (Last Assessment)	24.5 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (Last Assessment)	25.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (Last Assessment)	12.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (OLE D1)	9.4 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (OLE M3)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (OLE D1)	12.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (OLE M9)	3.6 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (OLE D1)	28.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (OLE M3)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (OLE D1)	43.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (OLE M12)	3.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (OLE D1)	3.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (OLE M3)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (OLE D1)	3.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (OLE M9)	3.6 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (OLE D1)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (OLE M6)	10.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (OLE M1)	12.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (Last Assessment)	18.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (OLE M1)	15.6 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (OLE M6)	31.0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (OLE M1)	31.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (OLE M9)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (OLE M1)	40.6 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (OLE M6)	34.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (OLE M12)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (Last Assessment)	9.4 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (OLE M6)	20.7 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (Last Assessment)	3.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (OLE M12)	19.2 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (Last Assessment)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (OLE M1)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (OLE M6)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (OLE M1)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (Last Assessment)	28.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (OLE M1)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (OLE M6)	3.4 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (OLE M2)	12.9 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (OLE M12)	26.9 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (OLE M2)	16.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (OLE M6)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (OLE M2)	41.9 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (OLE M12)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (OLE M2)	22.6 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (OLE M9)	14.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	5=Minimally worse (OLE M2)	6.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (OLE M12)	46.2 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	6=Much worse (OLE M2)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (OLE M9)	25.0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	7=Very much worse (OLE M2)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (Last Assessment)	28.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	1=Very much improved (OLE M3)	13.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (OLE M9)	21.4 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	2=Much improved (OLE M3)	10.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (OLE M12)	3.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	3=Minimally improved (OLE M3)	37.9 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (OLE M9)	32.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver	4=No Change (OLE M3)	37.9 percentage of participants

Secondary

Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator

CGI-I scale measures improvement in the participant's condition from Baseline. The severity of a participant's condition was rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), as follows: 1-very much improved,2-much improved, 3-minimally improved, 4- no change, 5-minimally worse, 6-much worse and 7-very much worse.

Time frame: At OLE Day 1, OLE Months (M) 1, 2, 3, 6, 9, 12, and Last Assessment (up to 72 months)

Population: OLE mITT:participants who received \>=1 dose of ZX008, had valid estimate of frequency of seizures that resulted in drops from Part 1 and at least 1 month(30 days) of valid seizure data during OLE. N: participants evaluable for assessment. n: participants evaluable at specified time point. As pre-specified in study design, participants in Part 2 received individualized optimized treatment (0.2 mg/kg/day to 0.8 mg/kg/day) based on Investigator discretion. Hence overall data for Part 2 is reported.

Arm	Measure	Group	Value (NUMBER)
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	1=Very much improved (OLE M2)	5.5 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	2=Much improved (OLE D1)	15.3 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	3=Minimally improved (OLE D1)	25.8 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	4=No Change (OLE D1)	48.3 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	5=Minimally worse (OLE D1)	7.2 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	6=Much worse (OLE D1)	0.8 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	7=Very much worse (OLE D1)	0 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	1=Very much improved (OLE M1)	4.4 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	2=Much improved (OLE M1)	20.0 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	3=Minimally improved (OLE M1)	32.4 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	4=No Change (OLE M1)	34.2 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	5=Minimally worse (OLE M1)	7.6 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	6=Much worse (OLE M1)	1.3 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	7=Very much worse (OLE M1)	0 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	1=Very much improved (OLE D1)	2.5 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	2=Much improved (OLE M2)	24.5 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	3=Minimally improved (OLE M2)	34.1 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	4=No Change (OLE M2)	27.7 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	5=Minimally worse (OLE M2)	5.0 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	6=Much worse (OLE M2)	3.2 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	7=Very much worse (OLE M2)	0 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	1=Very much improved (OLE M3)	7.2 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	2=Much improved (OLE M3)	25.1 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	3=Minimally improved (OLE M3)	36.2 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	4=No Change (OLE M3)	21.7 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	5=Minimally worse (OLE M3)	7.2 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	6=Much worse (OLE M3)	2.4 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	7=Very much worse (OLE M3)	0 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	1=Very much improved (OLE M6)	8.2 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	2=Much improved (OLE M6)	33.7 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	3=Minimally improved (OLE M6)	31.0 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	4=No Change (OLE M6)	20.1 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	5=Minimally worse (OLE M6)	3.8 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	6=Much worse (OLE M6)	3.3 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	7=Very much worse (OLE M6)	0 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	1=Very much improved (OLE M9)	9.0 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	2=Much improved (OLE M9)	37.6 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	3=Minimally improved (OLE M9)	27.1 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	4=No Change (OLE M9)	18.8 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	5=Minimally worse (OLE M9)	6.0 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	6=Much worse (OLE M9)	1.5 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	7=Very much worse (OLE M9)	0 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	1=Very much improved (OLE M12)	9.7 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	2=Much improved (OLE M12)	39.3 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	3=Minimally improved (OLE M12)	26.2 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	4=No Change (OLE M12)	18.6 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	5=Minimally worse (OLE M12)	3.4 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	6=Much worse (OLE M12)	2.8 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	7=Very much worse (OLE M12)	0 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	1=Very much improved (Last Assessment)	7.6 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	2=Much improved (Last Assessment)	27.4 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	3=Minimally improved (Last Assessment)	21.9 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	4=No Change (Last Assessment)	28.3 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	5=Minimally worse (Last Assessment)	7.2 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	6=Much worse (Last Assessment)	7.6 percentage of participants
Cohort A: Placebo	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	7=Very much worse (Last Assessment)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	4=No Change (Last Assessment)	40.6 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	1=Very much improved (OLE D1)	3.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	1=Very much improved (OLE M6)	3.4 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	2=Much improved (OLE D1)	18.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	1=Very much improved (OLE M12)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	3=Minimally improved (OLE D1)	18.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	2=Much improved (OLE M6)	27.6 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	4=No Change (OLE D1)	56.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	1=Very much improved (Last Assessment)	6.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	5=Minimally worse (OLE D1)	3.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	3=Minimally improved (OLE M6)	34.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	6=Much worse (OLE D1)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	2=Much improved (OLE M12)	53.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	7=Very much worse (OLE D1)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	4=No Change (OLE M6)	27.6 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	1=Very much improved (OLE M1)	9.4 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	6=Much worse (Last Assessment)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	2=Much improved (OLE M1)	21.9 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	5=Minimally worse (OLE M6)	6.9 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	3=Minimally improved (OLE M1)	37.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	3=Minimally improved (OLE M12)	23.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	4=No Change (OLE M1)	31.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	6=Much worse (OLE M6)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	5=Minimally worse (OLE M1)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	2=Much improved (Last Assessment)	25.0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	6=Much worse (OLE M1)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	7=Very much worse (OLE M6)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	7=Very much worse (OLE M1)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	4=No Change (OLE M12)	19.2 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	1=Very much improved (OLE M2)	6.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	1=Very much improved (OLE M9)	3.6 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	2=Much improved (OLE M2)	19.4 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	5=Minimally worse (Last Assessment)	3.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	3=Minimally improved (OLE M2)	35.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	2=Much improved (OLE M9)	28.6 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	4=No Change (OLE M2)	32.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	5=Minimally worse (OLE M12)	3.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	5=Minimally worse (OLE M2)	6.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	3=Minimally improved (OLE M9)	28.6 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	6=Much worse (OLE M2)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	3=Minimally improved (Last Assessment)	25.0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	7=Very much worse (OLE M2)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	4=No Change (OLE M9)	35.7 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	1=Very much improved (OLE M3)	6.9 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	6=Much worse (OLE M12)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	2=Much improved (OLE M3)	17.2 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	5=Minimally worse (OLE M9)	3.6 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	3=Minimally improved (OLE M3)	55.2 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	7=Very much worse (Last Assessment)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	4=No Change (OLE M3)	20.7 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	6=Much worse (OLE M9)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	5=Minimally worse (OLE M3)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	7=Very much worse (OLE M12)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	6=Much worse (OLE M3)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	7=Very much worse (OLE M9)	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator	7=Very much worse (OLE M3)	0 percentage of participants

Secondary

Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Motor Seizures

Countable motor seizures included: GTC, SGTC, TS, AS, TA, CS, HS, and FS with clearly observable signs. The participants who experienced a worsening or no change from Baseline (ie \<= 0% reduction); \>0%, \>=25%, \>=50%, \>=75%, and 100% reduction (a 100% reduction was equivalent to achieving seizure freedom during OLE Period); and near seizure freedom, (defined as 0 or 1 seizure leading to a drop) during OLE Period were reported.

Time frame: From OLE Month 1 to Month12, compared to Baseline (Part 1)

Arm	Measure	Group	Value (NUMBER)
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Motor Seizures	>= 25%	54.8 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Motor Seizures	>= 75%	9.1 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Motor Seizures	> 0%	70.5 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Motor Seizures	100%	0.4 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Motor Seizures	>= 50%	29.9 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Motor Seizures	Near Seizure free	0.8 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Motor Seizures	Worsening or No Change	29.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Motor Seizures	Near Seizure free	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Motor Seizures	Worsening or No Change	21.9 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Motor Seizures	> 0%	78.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Motor Seizures	>= 25%	62.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Motor Seizures	>= 50%	40.6 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Motor Seizures	>= 75%	21.9 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Motor Seizures	100%	0 percentage of participants

Secondary

Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Non-motor Seizures

Countable non-motor seizures included: FS without clear observable signs, MS, absence/atypical absence, infantile spasms, epileptic spasms, and other seizures. The participants who experienced a worsening or no change from Baseline (ie \<= 0% reduction); \>0%, \>=25%, \>=50%, \>=75%, and 100% reduction (a 100% reduction was equivalent to achieving seizure freedom during OLE Period); and near seizure freedom, (defined as 0 or 1 seizure leading to a drop) during OLE Period were reported.

Time frame: From OLE Month 1 to Month12, compared to Baseline (Part 1)

Arm	Measure	Group	Value (NUMBER)
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Non-motor Seizures	>= 25%	41.9 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Non-motor Seizures	>= 75%	22.8 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Non-motor Seizures	> 0%	46.1 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Non-motor Seizures	100%	4.6 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Non-motor Seizures	>= 50%	34.0 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Non-motor Seizures	Near Seizure free	7.5 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Non-motor Seizures	Worsening or No Change	24.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Non-motor Seizures	Near Seizure free	6.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Non-motor Seizures	Worsening or No Change	37.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Non-motor Seizures	> 0%	31.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Non-motor Seizures	>= 25%	25.0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Non-motor Seizures	>= 50%	18.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Non-motor Seizures	>= 75%	6.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Non-motor Seizures	100%	3.1 percentage of participants

Secondary

Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Seizures

Countable motor seizures included: GTC, SGTC; TS, AS, TA, CS, HS, and FS with clearly observable signs. Countable non-motor seizures included: FS without clear observable signs, MS, absence/atypical absence, infantile spasms, epileptic spasms, and other seizures. The participants who experienced a worsening or no change from Baseline (ie \<= 0% reduction); \>0%, \>=25%, \>=50%, \>=75%, and 100% reduction (a 100% reduction was equivalent to achieving seizure freedom during OLE Period); and near seizure freedom, (defined as 0 or 1 seizure leading to a drop) during OLE Period were reported.

Time frame: From OLE Month 1 to Month12, compared to Baseline (Part 1)

Arm	Measure	Group	Value (NUMBER)
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Seizures	>= 25%	53.1 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Seizures	>= 75%	9.1 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Seizures	> 0%	69.7 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Seizures	100%	0.4 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Seizures	>= 50%	30.7 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Seizures	Near Seizure free	0.4 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Seizures	Worsening or No Change	30.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Seizures	Near Seizure free	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Seizures	Worsening or No Change	37.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Seizures	> 0%	62.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Seizures	>= 25%	56.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Seizures	>= 50%	28.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Seizures	>= 75%	12.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Seizures	100%	0 percentage of participants

Secondary

Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Result in Drops (ESC Confirmed)

The seizure types included in the count were: atonic, tonic, tonic/atonic, generalized tonic-clonic, and secondarily generalized tonic-clonic seizures resulting in drops. The participants who experienced a worsening or no change from Baseline (ie \<= 0% reduction); \>0%, \>=25%, \>=50%, \>=75%, and 100% reduction (a 100% reduction was equivalent to achieving seizure freedom during OLE Period); and near seizure freedom, (defined as 0 or 1 seizure leading to a drop) during OLE Period were reported.

Time frame: From OLE Month 1 to Month12, compared to Baseline (Part 1)

Arm	Measure	Group	Value (NUMBER)
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Result in Drops (ESC Confirmed)	>= 25%	55.6 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Result in Drops (ESC Confirmed)	>= 75%	12.4 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Result in Drops (ESC Confirmed)	> 0%	68.5 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Result in Drops (ESC Confirmed)	100%	1.2 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Result in Drops (ESC Confirmed)	>= 50%	32.8 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Result in Drops (ESC Confirmed)	Near Seizure free	1.7 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Result in Drops (ESC Confirmed)	Worsening or No Change	31.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Result in Drops (ESC Confirmed)	Near Seizure free	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Result in Drops (ESC Confirmed)	Worsening or No Change	18.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Result in Drops (ESC Confirmed)	> 0%	81.3 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Result in Drops (ESC Confirmed)	>= 25%	62.5 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Result in Drops (ESC Confirmed)	>= 50%	43.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Result in Drops (ESC Confirmed)	>= 75%	21.9 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Result in Drops (ESC Confirmed)	100%	0 percentage of participants

Secondary

Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Typically Result in Drops

Seizures that typically result in drops included all: GTC, SGTC, TS, AS, and TA, whether confirmed by the ESC or not. The participants who experienced a worsening or no change from Baseline (ie \<= 0% reduction); \>0%, \>=25%, \>=50%, \>=75%, and 100% reduction (a 100% reduction was equivalent to achieving seizure freedom during OLE Period); and near seizure freedom, (defined as 0 or 1 seizure leading to a drop) during OLE Period were reported.

Time frame: From OLE Month 1 to Month12, compared to Baseline (Part 1)

Arm	Measure	Group	Value (NUMBER)
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Typically Result in Drops	>= 25%	53.1 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Typically Result in Drops	>= 75%	11.2 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Typically Result in Drops	> 0%	68.0 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Typically Result in Drops	100%	0.8 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Typically Result in Drops	>= 50%	29.9 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Typically Result in Drops	Near Seizure free	1.2 percentage of participants
Cohort A: Placebo	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Typically Result in Drops	Worsening or No Change	32.0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Typically Result in Drops	Near Seizure free	0 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Typically Result in Drops	Worsening or No Change	21.9 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Typically Result in Drops	> 0%	78.1 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Typically Result in Drops	>= 25%	65.6 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Typically Result in Drops	>= 50%	43.8 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Typically Result in Drops	>= 75%	21.9 percentage of participants
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Typically Result in Drops	100%	0 percentage of participants

Secondary

Part 2: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in OLE Period

Countable motor seizures included: GTC, SGTC, TS, AS, TA, clonic seizures \[CS\], hemiclonic seizures \[HS\], and focal seizures \[FS\] with clearly observable signs.

Time frame: From OLE Month 1 to Month12, compared to Baseline (Part 1)

Arm	Measure	Value (MEDIAN)
Cohort A: Placebo	Part 2: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in OLE Period	-28.18 percent change
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in OLE Period	-41.94 percent change

Secondary

Part 2: Percent Change From Baseline in the Frequency of All Countable Seizures (ESC Confirmed or Not) in OLE Period

Time frame: From OLE Month 1 to Month12, compared to Baseline (Part 1)

Arm	Measure	Value (MEDIAN)
Cohort A: Placebo	Part 2: Percent Change From Baseline in the Frequency of All Countable Seizures (ESC Confirmed or Not) in OLE Period	-28.83 percent change
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percent Change From Baseline in the Frequency of All Countable Seizures (ESC Confirmed or Not) in OLE Period	-28.00 percent change

Secondary

Part 2: Percent Change From Baseline in the Frequency of All Seizures That Typically Result in Drops Between Baseline and the OLE Period Whether ESC Confirmed as Drop or Not

Time frame: From OLE Month 1 to Month12, compared to Baseline (Part 1)

Arm	Measure	Value (MEDIAN)
Cohort A: Placebo	Part 2: Percent Change From Baseline in the Frequency of All Seizures That Typically Result in Drops Between Baseline and the OLE Period Whether ESC Confirmed as Drop or Not	-27.94 percent change
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percent Change From Baseline in the Frequency of All Seizures That Typically Result in Drops Between Baseline and the OLE Period Whether ESC Confirmed as Drop or Not	-43.78 percent change

Secondary

Part 2: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC Confirmed) in OLE Period

Time frame: From OLE Month 1 to Month12, compared to Baseline (Part 1)

Population: The Open-Label Extension Modified Intent-To-Treat (mITT) Population included all participants who received at least 1 dose of ZX008 and had a valid estimate of the frequency of seizures that resulted in drops from Part 1 and at least 1 month (30 days) of valid seizure data during the OLE. As pre-specified in study design, participants in Part 2 received individualized optimized treatment (0.2 mg/kg/day to 0.8 mg/kg/day) based on Investigator discretion. Hence overall data for Part 2 is reported.

Arm	Measure	Value (MEDIAN)
Cohort A: Placebo	Part 2: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC Confirmed) in OLE Period	-29.53 percent change
Cohort A: ZX008 0.8 mg/kg/Day	Part 2: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC Confirmed) in OLE Period	-43.42 percent change

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026

A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome

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Brief summary

Related papers

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Primary

Secondary

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Participants by arm

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Baseline characteristics

Adverse events

Outcome results

Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC-confirmed) in the Combined Titration and Maintenance Period (T+M) in the ZX008 0.8 mg/kg/Day Group Compared to the Placebo Group

Part 2: Percentage of Participants With Serious TEAEs

Part 2: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

Part 1: Area Under the Concentration-time Curve of Fenfluramine and Norfenfluramine From Time Zero to Time 24 Hours [AUC0-24hours] at Steady State

Part 1: Change From Baseline in Number of Seizure-free Days During T+M and M Period

Part 1: Change From Baseline in the Frequency of All Countable Non-motor Seizures in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo

Part 1: Change From Baseline in the Frequency of All Countable Non-motor Seizures in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo

Part 1: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver

Part 1: Duration of Longest Interval (Days) Between Seizures That Result in Drops Comparing the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo

Part 1: Maximum Observed Plasma Concentration of Fenfluramine and Norfenfluramine Determined Directly From the Concentration Time Profile [Cmax] at Steady State

Part 1: Minimum Observed Plasma Concentration of Fenfluramine and Norfenfluramine at Steady State Determined Directly From the Concentration-time Profile [Cmin] at Steady State

Part 1: Percentage of Participants Who Achieve a >=50% Reduction From Baseline in the Frequency of Seizures That Result in Drops Comparing the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo

Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <= 0% Reduction), or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Seizures

Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops

Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures

Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Non-motor Seizures

Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops

Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops

Part 1: Percentage of Participants Who Achieve Improvement (Minimally, Much or Very Much Improved) in the CGI-I Scale as Assessed by Principal Investigator Comparing ZX008 0.8 and 0.2 mg/kg/Day Groups Independently Versus Placebo

Part 1: Percentage of Participants With Serious TEAEs

Part 1: Percentage of Participants With TEAEs

Part 1: Percent Change From Baseline in Frequency of All Seizures That Typically Result in Drops in T+M, Whether ESC-confirmed as Drop or Not in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo

Part 1: Percent Change From Baseline in Frequency of Countable Seizures That do Not Result in Drops (ESC Confirmed)

Part 1: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo

Part 1: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo

Part 1: Percent Change From Baseline in the Frequency of All Countable Seizures (Motor and Non-motor) in the Maintenance Period in ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo

Part 1: Percent Change From Baseline in the Frequency of All Countable Seizures (Motor and Non-motor) in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo

Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC Confirmed) Between Baseline and the Maintenance Period

Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC-confirmed) in T+M in the ZX008 0.2 mg/kg/Day Group Compared to the Placebo Group

Part 1: Percent Change From Baseline in the Frequency of Seizures That Typically Result in Drops in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo

Part 2: Change From Baseline in Duration of Longest Interval Between Seizures That Result in Drops (ESC Confirmed) in OLE Period

Part 2: Change From Baseline in Number of Seizure-free Days Per 28 Days (ESC Confirmed) in OLE Period

Part 2: Change From Baseline in the Frequency of All Countable Non-motor Seizures in OLE Period

Part 2: Change From Baseline in the Frequency of All Countable Seizures That Did Not Result in Drops (ESC Confirmed) in OLE Period

Part 2: Clinical Global Impression - Improvement as Assessed by the Parent/Caregiver

Part 2: Clinical Global Impression - Improvement as Assessed by the Principal Investigator

Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Motor Seizures

Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Non-motor Seizures

Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of All Countable Seizures

Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Result in Drops (ESC Confirmed)

Part 2: Percentage of Participants Who Achieved a Worsening From Baseline, or > 0%, >=25%, >= 50%, >= 75%, 100% Reduction, and Near Seizure Freedom From Baseline in Frequency of Seizures That Typically Result in Drops

Part 2: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in OLE Period

Part 2: Percent Change From Baseline in the Frequency of All Countable Seizures (ESC Confirmed or Not) in OLE Period

Part 2: Percent Change From Baseline in the Frequency of All Seizures That Typically Result in Drops Between Baseline and the OLE Period Whether ESC Confirmed as Drop or Not

Part 2: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC Confirmed) in OLE Period