Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy

UCB

Status and phase

Completed

Phase 2

Conditions

Epilepsy

Treatments

Drug: Lacosamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01118949

2014-004379-22 (EudraCT Number)

SP0961

Details and patient eligibility

About

The purpose is to assess the safety of Lacosamide in subjects with uncontrolled Primary Generalized Tonic-Clonic (PGTC) seizures with Idiopathic Generalized Epilepsy.

Enrollment

49 patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject has a diagnosis of uncontrolled epilepsy with primary generalized tonic-clonic (PGTC) seizures and idiopathic generalized epilepsy. Diagnosis should have been established by an electroencephalogram (EEG) with generalized spike-wave discharges within 5 years of the screening visit
Subject has ≥1 PGTC seizure within the 12 weeks prior to the screening visit
Subject has a stable dose regimen of 1 to 3 marketed antiepileptic drug(s) (AEDs) with or without additional concurrent stable Vagus Nerve Stimulation (VNS). The VNS must have been in place for at least 6 months prior to study entry with constant settings for at least 28 days prior to the screening visit and during the Baseline Phase. Benzodiazepines will be counted as an AED

Exclusion criteria

Subject has a history of partial-onset seizures or EEG findings consistent with partial onset seizures
Subject has a history of status epilepticus within the 5-year Period prior to Visit 1
Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or other non-epileptic ictal events
Subject has any medical or psychiatric condition
Subject has any history of alcohol or drug abuse
Subject is currently taking felbamate
Subject has ever taken vigabatrin and has no visual fields examination report available or if results of the examination are abnormal
Subject is on a ketogenic diet
Subject has a known sodium channelopathy