Catamenial Epilepsy, Partial Epilepsy
Conditions
Keywords
Partial onset seizures, Complex-partial seizures, Anticonvulsant, Partial seizures, Catamenial epilepsy
Brief summary
The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs). The study will also evaluate the effectiveness of ganaxolone in females with catamenial epilepsy. Catamenial epilepsy refers to a relationship between seizure frequency and a woman's menstrual cycle, where the number of seizures increases around the time of a woman's menstrual cycle.
Interventions
DRUGGanaxolone
Oral suspension 200-500 mg 3x/day
OTHERPlacebo
non-active placebo
Sponsors
Marinus Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of epilepsy with POS with or without secondary generalized seizures according to the International League Against Epilepsy \[ILAE\] Classification of Epileptic Seizures (1981). Diagnosis should have been established by clinical history and CT or MRI of the brain to rule out progressive structural lesions and EEG with results consistent with partial-onset epilepsy. * During the 8 week baseline period preceding randomization visit (Visit 4), participants should have a documented seizure frequency of ≥ 3CPS per 4 weeks on average. * Participants should not be seizure free for more than 28 consecutive days during treatment with a stable dose of AEDs \[Note: Participants with historically sufficiently high seizure frequency who fall short 1 seizure in any 4 weeks period or with a seizure-free period \> 28 consecutive days may be allowed to enter the study after discussion with the Medical Monitor. Prolongation of the screening period for questionable cases may also be allowed by the Medical Monitor.\] * Treatment with a stable dose of up to 3 (FDA approved) current AEDs for 1 month prior to screening. * Maintenance of current AEDs without a change in dosing for the duration of study. * Concomitant vigabatrin not permitted; * Felbamate is allowed if the participant has been on felbamate for at least 18 months and has stable laboratory tests) for the course of the study. \[Note: A shorter period for stable laboratory results may be allowed by the Medical Monitor, depending on the extent of dose change and the half-life of the AED.\] * Participants receiving treatment with a vagal nerve stimulator (VNS) may be included as long as the VNS has been in place for at least 12 months prior to entry into the study, the VNS battery is not due for replacement during 0600 subject participation, and stimulation parameters have been kept constant for 1 month prior to screening. VNS will be counted as 1 of the 3 concomitant AEDs. * Male or female, 18 to 69 years of age (inclusive). \[Note: Participants who are \> 69 years of age but are of good health condition may be allowed to enter the study after discussion with and approval by the Medical Monitor.\] * A 12-lead electrocardiogram (ECG) w/o clinically significant abnormalities. * Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study. * Able to participate for the full term of study. * Able to keep a seizure & medication diary throughout the course of the study. * Sexually active women of childbearing potential (WCBP) must be using a medically acceptable method of birth control and have a negative qualitative β-human chorionic growth hormone (β-HCG) pregnancy test result from a urine sample collected at the initial screening visit. A woman of childbearing potential is defined as a female who is biologically capable of becoming pregnant. A medically acceptable method of birth control includes intrauterine devices in place for at least 3 months, surgical sterilization, or adequate barrier methods (e.g., diaphragm and foam). An oral contraceptive alone is not considered adequate for the purpose of this study. Use of oral contraceptives in combination with another method (eg, a spermicidal cream) is acceptable.in participants who are not sexually active, abstinence is an acceptable form of birth control and serum β-HCG must be tested per protocol. * Participants with a history of depression who are stable and may be taking 1 anti-depressant medication.
Exclusion criteria
* Presence of non-motor simple partial seizures only. * History of pseudoseizures in the last 5 years. * History of a primary generalized seizure in the last 5 years. * Past use of vigabatrin without stable visual fields tested twice over the 12 months after the last dose of vigabatrin (Concomitant use of vigabatrin is not allowed). * Seizures secondary to illicit drug or alcohol use, infection, neoplasia, demyelinating disease, degenerative neurological disease, or CNS disease deemed progressive, metabolic illness, or progressive degenerative disease. * Status epilepticus within the last year prior to randomization. * Clinically unstable psychiatric disorder within the last 2 years. * Suicidal attempt within the last 5 years or current significant suicidal ideation. * History of psychosis within the last 5 years. \[Note: Participants who suffered a psychosis that can well be explained by exogenous factors may be allowed to enter the study after discussion with and approval by the Medical Monitor.\] * Current use of neuroleptics for psychosis. * A significant medical or surgical condition at screening which might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic systems or other conditions that would place the subject at increased risk. * Known sensitivity or allergy to progesterone or related steroid compounds. * History of drug use or alcohol abuse within the past 5 years. * Sexually active WCBP who are unwilling to use a double-barrier method and establish that they are currently not pregnant by submitting to a pregnancy test. * Females who are currently breastfeeding. * history of chronic noncompliance with drug regimens. * Exposure to any other investigational drug or device within 30 days prior to screening. * Alanine transferase (ALT; SGPT) or Aspartate transferase (AST; SGOT) levels \> 3 times upper limits of normal (ULN) at screening. * Benzodiazepines may be used intermittently for the control of seizure clustering as a one time rescue up to a maximum of 4 occasions as follows: * Participants who need benzodiazepines for control of seizures more than once per month or more than 4 times total during the Titration and Maintenance Phases will be discontinued. * Once during the Titration Phase * No more than once per month during the Maintenance Phase * Each occasion may be a period of 24 hours, during which up to 3 doses of benzodiazepine may be used. * If a participant is taking a benzodiazepine chronically for epilepsy and non-epilepsy conditions, it will be counted as 1 of the 3 AEDs and the dose cannot be changed during the study. * Participant has history of repetitive seizures within the 12-month period preceding study entry where the individual seizures cannot be counted. * Inability to withhold grapefruit and grapefruit juice from diet for the entire clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Weekly Log-transformed Seizure Frequency During Weeks 1 Through 10 | Week 1 through Week 10 | Weekly seizure frequency, analyzed as mean weekly log-transformed seizure frequency \[including partial-onset seizures (POS) with or without secondary generalization, but not non-motor simple partial seizure (SPS)\] during Weeks 1 through 10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Weekly Seizure Frequency During Weeks 1 Through 10 | Baseline and at Week 1 through Week 10 | Summary of change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Change From Baseline in Mean Weekly Seizure Frequency During Weeks 3 Through 10 | Baseline and at Week 3 through Week 10 | Summary of change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Percent Change From Baseline in Mean Weekly Seizure Frequency During Weeks 1 Through 10 | Baseline and at Week 1 through Week 10 | Summary of percent change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Percent Change From Baseline in Mean Weekly Seizure Frequency During Weeks 3 Through 10 | Baseline and at Week 3 through Week 10 | Summary of percent change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10 | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 | Mean weekly Seizure Frequency for each week post-dosing During Weeks 1 to 10 is presented. |
| Percent Change From Baseline in Mean Weekly Seizure Frequency by Subtype During Weeks 1 Through 10 | Baseline and at Week 1 through Week 10 | Seizure subtypes included Complex partial seizures (CPS), Generalized tonic-clonic seizure (GTCS), and Simple partial seizure (SPS)-motor. Percent Change from Baseline in Mean Weekly Seizure frequency by seizure subtype is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Number of Responders During Weeks 1 Through 10 | Baseline and at Week 1 through Week 10 | Responders were defined as participants experiencing ≥50% of reduction in mean weekly seizure frequency from the Baseline. Baseline was defined as the Day 0 assessment before study drug infusion. |
| Mean Weekly Log-transformed Seizure Frequency During Weeks 3 Through 10 | Week 3 through Week 10 | Weekly seizure frequency, analyzed as mean weekly log-transformed seizure frequency \[including POS with or without secondary generalization, but not non-motor SPS\] during the Weeks 3 through 10 |
| Number of Seizure-free Participants Up to Week 2 | Up to Week 2 | Number of seizure-free participants is presented. |
| Number of Seizure-free Participants During Weeks 3 Through 10 | Week 3 through Week 10 | Number of seizure-free participants is presented. |
| Number of Seizure-free Participants During Weeks 1 Through 10 | Week 1 through Week 10 | Number of seizure-free participants is presented. |
| Number of Seizure-free Days Up to Week 2 | Up to Week 2 | Summary of Seizure-Free days is presented. |
| Number of Seizure-free Days During Week 3 Through 10 | Week 3 through Week 10 | Summary of Seizure-Free days is presented. |
| Number of Seizure-free Days During Week 1 Through 10 | Week 1 through Week 10 | Summary of Seizure-Free days is presented. |
| Number of Responders During Weeks 3 Through 10 | Baseline and at Week 3 through Week 10 | Responders were defined as participants experiencing ≥50% of reduction in mean weekly seizure frequency from the Baseline. Baseline was defined as the Day 0 assessment before study drug infusion. |
Countries
United States
Participant flow
Recruitment details
No recruitment details specified
Pre-assignment details
Participants were randomized (Visit 4, Week 0, before dosing) to receive investigational product in an active:placebo ratio of 2:1.
Participants by arm
| Arm | Count |
|---|---|
| Ganaxolone Suspension formulation 50 mg/mL TID | 98 |
| Placebo Placebo Suspension 50 mg/mL TID | 49 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 3 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | Ganaxolone | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 39.1 years STANDARD_DEVIATION 11.74 | 39.5 years STANDARD_DEVIATION 11.51 | 40.2 years STANDARD_DEVIATION 11.11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 11 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 91 Participants | 136 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 12 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) White | 87 Participants | 129 Participants | 42 Participants |
| Region of Enrollment United States | 98 participants | 147 participants | 49 participants |
| Sex: Female, Male Female | 64 Participants | 100 Participants | 36 Participants |
| Sex: Female, Male Male | 34 Participants | 47 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 98 | 0 / 49 |
| other Total, other adverse events | 82 / 98 | 38 / 49 |
| serious Total, serious adverse events | 5 / 98 | 4 / 49 |
Outcome results
Primary
Mean Weekly Log-transformed Seizure Frequency During Weeks 1 Through 10
Weekly seizure frequency, analyzed as mean weekly log-transformed seizure frequency \[including partial-onset seizures (POS) with or without secondary generalization, but not non-motor simple partial seizure (SPS)\] during Weeks 1 through 10.
Time frame: Week 1 through Week 10
Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ganaxolone | Mean Weekly Log-transformed Seizure Frequency During Weeks 1 Through 10 | 5.20 log[seizures per week] | Standard Deviation 9.286 |
| Placebo | Mean Weekly Log-transformed Seizure Frequency During Weeks 1 Through 10 | 10.77 log[seizures per week] | Standard Deviation 44.156 |
Secondary
Change From Baseline in Mean Weekly Seizure Frequency During Weeks 1 Through 10
Summary of change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline and at Week 1 through Week 10
Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ganaxolone | Change From Baseline in Mean Weekly Seizure Frequency During Weeks 1 Through 10 | -1.27 Seizures per week | Standard Deviation 3.567 |
| Placebo | Change From Baseline in Mean Weekly Seizure Frequency During Weeks 1 Through 10 | 1.41 Seizures per week | Standard Deviation 15.075 |
Secondary
Change From Baseline in Mean Weekly Seizure Frequency During Weeks 3 Through 10
Summary of change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline and at Week 3 through Week 10
Population: Only those participants with data available during Weeks 3 to 10 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ganaxolone | Change From Baseline in Mean Weekly Seizure Frequency During Weeks 3 Through 10 | -1.07 Seizures per week | Standard Deviation 3.909 |
| Placebo | Change From Baseline in Mean Weekly Seizure Frequency During Weeks 3 Through 10 | 2.52 Seizures per week | Standard Deviation 20.229 |
Secondary
Mean Weekly Log-transformed Seizure Frequency During Weeks 3 Through 10
Weekly seizure frequency, analyzed as mean weekly log-transformed seizure frequency \[including POS with or without secondary generalization, but not non-motor SPS\] during the Weeks 3 through 10
Time frame: Week 3 through Week 10
Population: Only those participants with data available during Weeks 3 to 10 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ganaxolone | Mean Weekly Log-transformed Seizure Frequency During Weeks 3 Through 10 | 5.44 log[seizures per week] | Standard Deviation 9.431 |
| Placebo | Mean Weekly Log-transformed Seizure Frequency During Weeks 3 Through 10 | 11.90 log[seizures per week] | Standard Deviation 50.209 |
Secondary
Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10
Mean weekly Seizure Frequency for each week post-dosing During Weeks 1 to 10 is presented.
Time frame: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
Population: ITT Population. Only those participants with data available at the specified data points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ganaxolone | Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10 | Week 1 | 4.53 Seizures per week | Standard Deviation 11.195 |
| Ganaxolone | Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10 | Week 2 | 5.09 Seizures per week | Standard Deviation 9.638 |
| Ganaxolone | Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10 | Week 3 | 5.02 Seizures per week | Standard Deviation 9.743 |
| Ganaxolone | Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10 | Week 4 | 5.69 Seizures per week | Standard Deviation 10.738 |
| Ganaxolone | Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10 | Week 5 | 5.12 Seizures per week | Standard Deviation 9.085 |
| Ganaxolone | Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10 | Week 6 | 5.65 Seizures per week | Standard Deviation 8.894 |
| Ganaxolone | Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10 | Week 7 | 6.68 Seizures per week | Standard Deviation 10.894 |
| Ganaxolone | Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10 | Week 8 | 4.63 Seizures per week | Standard Deviation 8.401 |
| Ganaxolone | Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10 | Week 9 | 5.07 Seizures per week | Standard Deviation 9.897 |
| Ganaxolone | Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10 | Week 10 | 4.83 Seizures per week | Standard Deviation 9.282 |
| Placebo | Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10 | Week 8 | 13.47 Seizures per week | Standard Deviation 63.157 |
| Placebo | Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10 | Week 1 | 7.25 Seizures per week | Standard Deviation 21.668 |
| Placebo | Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10 | Week 6 | 10.43 Seizures per week | Standard Deviation 38.133 |
| Placebo | Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10 | Week 2 | 8.79 Seizures per week | Standard Deviation 34.548 |
| Placebo | Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10 | Week 10 | 13.60 Seizures per week | Standard Deviation 56.711 |
| Placebo | Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10 | Week 3 | 7.80 Seizures per week | Standard Deviation 28.163 |
| Placebo | Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10 | Week 7 | 13.15 Seizures per week | Standard Deviation 62.762 |
| Placebo | Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10 | Week 4 | 9.13 Seizures per week | Standard Deviation 30.768 |
| Placebo | Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10 | Week 9 | 11.64 Seizures per week | Standard Deviation 49.387 |
| Placebo | Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10 | Week 5 | 11.64 Seizures per week | Standard Deviation 42.864 |
Secondary
Number of Responders During Weeks 1 Through 10
Responders were defined as participants experiencing ≥50% of reduction in mean weekly seizure frequency from the Baseline. Baseline was defined as the Day 0 assessment before study drug infusion.
Time frame: Baseline and at Week 1 through Week 10
Population: ITT Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ganaxolone | Number of Responders During Weeks 1 Through 10 | 23 Participants |
| Placebo | Number of Responders During Weeks 1 Through 10 | 7 Participants |
Secondary
Number of Responders During Weeks 3 Through 10
Responders were defined as participants experiencing ≥50% of reduction in mean weekly seizure frequency from the Baseline. Baseline was defined as the Day 0 assessment before study drug infusion.
Time frame: Baseline and at Week 3 through Week 10
Population: ITT Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ganaxolone | Number of Responders During Weeks 3 Through 10 | 25 Participants |
| Placebo | Number of Responders During Weeks 3 Through 10 | 6 Participants |
Secondary
Number of Seizure-free Days During Week 1 Through 10
Summary of Seizure-Free days is presented.
Time frame: Week 1 through Week 10
Population: ITT Population. Only those participants with data available at the specified data points were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ganaxolone | Number of Seizure-free Days During Week 1 Through 10 | 45.9 Seizure free days | Standard Deviation 22.11 |
| Placebo | Number of Seizure-free Days During Week 1 Through 10 | 46.8 Seizure free days | Standard Deviation 20.59 |
Secondary
Number of Seizure-free Days During Week 3 Through 10
Summary of Seizure-Free days is presented.
Time frame: Week 3 through Week 10
Population: Only those participants with data available during Weeks 3 to 10 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ganaxolone | Number of Seizure-free Days During Week 3 Through 10 | 37.1 Seizure free days | Standard Deviation 18.5 |
| Placebo | Number of Seizure-free Days During Week 3 Through 10 | 38.5 Seizure free days | Standard Deviation 16.17 |
Secondary
Number of Seizure-free Days Up to Week 2
Summary of Seizure-Free days is presented.
Time frame: Up to Week 2
Population: Only those participants with data available up to Week 2 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ganaxolone | Number of Seizure-free Days Up to Week 2 | 10.3 Seizure free days | Standard Deviation 4.41 |
| Placebo | Number of Seizure-free Days Up to Week 2 | 10.0 Seizure free days | Standard Deviation 3.78 |
Secondary
Number of Seizure-free Participants During Weeks 1 Through 10
Number of seizure-free participants is presented.
Time frame: Week 1 through Week 10
Population: ITT Population. Only those participants with data available at the specified data points were analyzed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ganaxolone | Number of Seizure-free Participants During Weeks 1 Through 10 | 1 Participants |
| Placebo | Number of Seizure-free Participants During Weeks 1 Through 10 | 0 Participants |
Secondary
Number of Seizure-free Participants During Weeks 3 Through 10
Number of seizure-free participants is presented.
Time frame: Week 3 through Week 10
Population: Only those participants with data available during Weeks 3 to 10 were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ganaxolone | Number of Seizure-free Participants During Weeks 3 Through 10 | 0 Participants |
| Placebo | Number of Seizure-free Participants During Weeks 3 Through 10 | 1 Participants |
Secondary
Number of Seizure-free Participants Up to Week 2
Number of seizure-free participants is presented.
Time frame: Up to Week 2
Population: Only those participants with data available Up to week 2 were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ganaxolone | Number of Seizure-free Participants Up to Week 2 | 16 Participants |
| Placebo | Number of Seizure-free Participants Up to Week 2 | 4 Participants |
Secondary
Percent Change From Baseline in Mean Weekly Seizure Frequency by Subtype During Weeks 1 Through 10
Seizure subtypes included Complex partial seizures (CPS), Generalized tonic-clonic seizure (GTCS), and Simple partial seizure (SPS)-motor. Percent Change from Baseline in Mean Weekly Seizure frequency by seizure subtype is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline and at Week 1 through Week 10
Population: Only those participants with data available during Weeks 1 to 10 were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ganaxolone | Percent Change From Baseline in Mean Weekly Seizure Frequency by Subtype During Weeks 1 Through 10 | CPS | -17.47 Percent change | Standard Error 51.055 |
| Ganaxolone | Percent Change From Baseline in Mean Weekly Seizure Frequency by Subtype During Weeks 1 Through 10 | GTC | -30.65 Percent change | Standard Error 79.104 |
| Ganaxolone | Percent Change From Baseline in Mean Weekly Seizure Frequency by Subtype During Weeks 1 Through 10 | SPS-motor | -30.63 Percent change | Standard Error 81.214 |
| Placebo | Percent Change From Baseline in Mean Weekly Seizure Frequency by Subtype During Weeks 1 Through 10 | CPS | 3.88 Percent change | Standard Error 82.986 |
| Placebo | Percent Change From Baseline in Mean Weekly Seizure Frequency by Subtype During Weeks 1 Through 10 | GTC | -37.75 Percent change | Standard Error 64.091 |
| Placebo | Percent Change From Baseline in Mean Weekly Seizure Frequency by Subtype During Weeks 1 Through 10 | SPS-motor | 19.70 Percent change | Standard Error 195.966 |
Secondary
Percent Change From Baseline in Mean Weekly Seizure Frequency During Weeks 1 Through 10
Summary of percent change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline and at Week 1 through Week 10
Population: ITT Population. Only those participants with data available at the specified data points were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ganaxolone | Percent Change From Baseline in Mean Weekly Seizure Frequency During Weeks 1 Through 10 | -17.59 Percent change | Standard Deviation 48.867 |
| Placebo | Percent Change From Baseline in Mean Weekly Seizure Frequency During Weeks 1 Through 10 | 1.99 Percent change | Standard Deviation 63.16 |
Secondary
Percent Change From Baseline in Mean Weekly Seizure Frequency During Weeks 3 Through 10
Summary of percent change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline and at Week 3 through Week 10
Population: Only those participants with data available during Weeks 3 to 10 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ganaxolone | Percent Change From Baseline in Mean Weekly Seizure Frequency During Weeks 3 Through 10 | -12.08 Percent change | Standard Deviation 54.286 |
| Placebo | Percent Change From Baseline in Mean Weekly Seizure Frequency During Weeks 3 Through 10 | 4.57 Percent change | Standard Deviation 71.88 |