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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Epilepsy Partial-onset Seizures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lacosamide (LCM)

On Day - 1, 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).

Group Type EXPERIMENTAL

Lacosamide (200 mg/20 mL)

Intervention Type DRUG

Active Substance: Lacosamide

Pharmaceutical form: Solution for intravenous (iv) infusion

Concentration: adapted on concentration of oral dose in EP0009

Route of Administration: Drip infusion

Interventions

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Lacosamide (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

Intervention Type DRUG

Other Intervention Names

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Vimpat

Eligibility Criteria

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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)

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No