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

Completed · Phase 2

Conditions studied: Epilepsy

In brief

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

Key facts

Study ID

NCT01118949

Run by

UCB BIOSCIENCES, Inc.

People needed

49

Starts

2010-05-01

Expected to finish

2011-08-01

Last updated by the study team

2018-07-17

Who can join

Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Alabaster, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — San Francisco, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Atlanta, Georgia, United States
• Study site — Rome, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Fort Wayne, Indiana, United States
• Study site — Lexington, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Scarborough, Maine, United States
• Study site — Bethesda, Maryland, United States
• Study site — Chesterfield, Missouri, United States
• Study site — New York, New York, United States
• Study site — Columbus, Ohio, United States
• Study site — Hershey, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Nashville, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Charlottesville, Virginia, United States
• Study site — Norfolk, Virginia, United States
• Study site — Renton, Washington, United States
• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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