A Double-blind, Randomized, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy – Protocol SP0982.
ClinicalTrials.gov Identifier: NCT02408523
Inclusion Criteria:
• Idiopathic generalized epilepsy (IGE) – primary generalized tonic-clonic seizures (PGTCS)
• Age ≥4 years
• ≥ 3 PGTCS during the 16-week Combined Baseline (12-week Historical Baseline plus 4-week Prospective Baseline)
• No imaging evidence of a lesion likely to be associated with partial-onset seizures
• Stable dose regimen of 1 – 2 non-benzodiazepine marketed anti-epileptic drugs (AEDs) OR 1 – 3 AEDs (with at least 1 AED identified as a benzodiazepine) for at least 28 days prior to Visit 1 with or without additional concurrent stable vagus nerve stimulation (VNS)
• An electroencephalogram (EEG) report consistent with IGE (eg, generalized ≥ 3Hz epileptiform discharges and a normal EEG background)
Exclusion Criteria:
• History of partial onset seizures or EEG findings indicating partial onset seizures
• Symptomatic generalized epilepsy, e.g. Lennox-Gastaut Syndrome
• Lifetime history of suicide attempt, or suicidal ideation in past 6 months
• Use of felbamate or vigabatrin within last 6 months
• Subject is on a ketogenic diet
Location:
David Vossler, MD and Carole Burton RN, Rainier Clinical Research Center, Inc.
Renton, Washington, United States, 98057. Phone 1 425-251-1720
