Open-label Study to Evaluate the Safety and Tolerability of iv Lacosamide in Japanese Adults With Partial-onset Seizures

A Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Intravenous Lacosamide as Replacement for Oral Lacosamide in Japanese Adults With Partial-onset Seizures With or Without Secondary Generalization

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02192814

Enrollment

Registered

2014-07-17

Start date

2014-06-30

Completion date

2014-12-31

Last updated

2017-08-25

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

Conditions

Epilepsy, Partial-onset Seizures

Keywords

Lacosamide, LCM, Epilepsy, Partial-onset seizures, iv

Brief summary

EP0024 is a Phase 3, multicenter, open-label study to evaluate the safety and tolerability of intravenous (iv) lacosamide (LCM). Adjunctive iv LCM therapy (200 mg/day to 400 mg/day) will be administered for 5 days as replacement for oral LCM tablets in Japanese adults with partial-onset seizures.

Interventions

DRUGLacosamide (200 mg/20 mL)

Active Substance: Lacosamide Pharmaceutical form: Solution for intravenous (iv) infusion Concentration: adapted on concentration of oral dose in EP0009 Route of Administration: Drip infusion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subject is Japanese and enrolled in EP0009 (NCT01832038) receiving oral Lacosamide (LCM) for the treatment of partial-onset seizures and has been enrolled for at least 8 weeks * Subject has been on a stable twice daily (bid) dosage regimen of LCM 200 mg/ day to 400 mg/ day, for the 2 weeks prior to entry into EP0024 * Subject has been receiving no more than 3 concomitant Antiepileptic Drugs (AEDs) at doses that have remained stable for the 2 weeks prior to entry into EP0024

Exclusion criteria

* Subject has a history of any kind of status epilepticus within 12-month period prior to study entry * Subject has actual suicidal ideation as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Since Last Visit version of the Columbia-Suicide Severity Rating Scale (C-SSRS)

Design outcomes

Primary

Measure	Time frame	Description
The Total Number of Subject Withdrawal Due to Adverse Events During the Study	During the study (Screening through End of Study (Day -1 through Day 6))	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
The Total Number of Subjects Experiencing at Least One Adverse Event During the Study	During the study (Screening through End of Study (Day -1 through Day 6))	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Secondary

Measure	Time frame
Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2	20 minutes prior infusion at Day 2
Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5	20 minutes prior infusion at Day 5
Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 2	20 minutes prior infusion at Day 2
Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 5	20 minutes prior infusion at Day 5
Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1	20 minutes prior infusion at Day 1
Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1	20 minutes prior infusion at Day 1

Other

Measure	Time frame	Description
The Cumulative Partial-onset Seizure Frequency From Day -1 to Day 5	From Day -1 to Day 5	No descriptive statistics have been calculated for this exploratory Outcome Measure.

Countries

Japan

Participant flow

Recruitment details

This multicenter, open-label study started recruiting in June 2014.

Pre-assignment details

Participant Flow refers to the Safety Set (SS), consisting of all enrolled subjects who received at least 1 infusion of iv LCM.

Participants by arm

Arm	Count
Lacosamide (LCM) On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply. During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days. The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day).	9
Total	9

Arm

Count

Lacosamide (LCM)

On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply. During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days. The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day).

Total

Baseline characteristics

Characteristic	Lacosamide (LCM)
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	9 Participants
Age, Continuous	26.9 years STANDARD_DEVIATION 10
Height	159.07 centimeter (cm) STANDARD_DEVIATION 8.63
Sex: Female, Male Female	5 Participants
Sex: Female, Male Male	4 Participants
Weight	55.99 kilogram (kg) STANDARD_DEVIATION 13.13

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	4 / 9
serious Total, serious adverse events	0 / 9

Outcome results

Primary

The Total Number of Subjects Experiencing at Least One Adverse Event During the Study

An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Time frame: During the study (Screening through End of Study (Day -1 through Day 6))