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

Phase 3CompletedNCT02192814

UCB Japan Co. Ltd.9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Epilepsy Partial-onset Seizures

Interventions

Lacosamide (200 mg/20 mL)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

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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)

Locations (5)

81027

Hamamatsu, Japan

81024

Kodaira, Japan

81025

Sapporo, Japan

81003

Shizuoka, Japan

81023

Suita, Japan

Outcomes

Primary Outcomes

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))

The Total Number of Subject Withdrawal Due to Adverse Events During the Study

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

Secondary Outcomes

Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1

Time frame: 20 minutes prior infusion at Day 1

Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2

Time frame: 20 minutes prior infusion at Day 2

Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5

Time frame: 20 minutes prior infusion at Day 5

Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1

Data from ClinicalTrials.gov

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