Epilepsy MedDRA version: 20.0 Level: LLT Classification code 10071096 Term: Idiopathic generalized epilepsy System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Vimpat 50 mg film-coated tablets
Product Name: Lacosamide
Product Code: SPM927
Pharmaceutical Form: Film-coated tablet
INN o
Sponsors
UCB BIOSCIENCES, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Subject with a confirmed diagnosis at least 24 weeks prior to Visit 1 and a disease onset prior to 30 years of age, consistent with idiopathic generalized epilepsy (IGE) experiencing primary generalized tonic-clonic (PGTC) seizures (Type IIE) that are classifiable according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (ILAE, 1981). ? Subject has >=3 PGTC seizures during the 16-week Combined Baseline (12-week Historical Baseline plus 4-week Prospective Baseline) ? If a brain magnetic resonance imaging (MRI)/computed tomography (CT) scan has been performed, there must be no evidence of any progressive abnormality or any lesion likely to be associated with partial-onset seizures. ? Subject has been maintained on a stable dose regimen of 1 to 2 non-benzodiazepine marketed Anti-epileptic drugs (AEDs) OR 1 to 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). ? Subjects are required to have had an electroencephalogram (EEG) report consistent with IGE (eg, generalized >= 3Hz epileptiform discharges and a normal EEG background) confirmed by a Central Reviewer. Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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 ? Women of child bearing potential must practice contraception according to protocol requirements ? Regular use of neuroleptics, narcotics, monoamine oxidase (MOA) inhibitors, barbiturates (for indication other than epilepsy) within 28 days prior to Visit 1 ? Use of Felbamate or Vigabatrin within last 6 months ? Subject is on a ketogenic diet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of oral lacosamide (LCM) vs placebo as adjunctive therapy for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized epilepsy (IGE) currently taking 1 to 3 concomitant anti-epileptic drugs (AEDs) independent of the number of prior failed AEDs;Secondary Objective: To assess the safety and tolerability of lacosamide (LCM) in subjects with idiopathic generalized epilepsy (IGE) with uncontrolled primary generalized tonic-clonic (PGTC) seizures;Primary end point(s): Time to the second primary generalized tonic clonic (PGTC) seizure;Timepoint(s) of evaluation of this end point: 24-week Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 24-week Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) From the Combined Baseline (combined 12-week Historical and 4-week Prospective Baseline) to the first 6 weeks of the Treatment Period ; Secondary end point(s): Seizure freedom for primary generalized tonic clonic (PGTC) seizures The percent change in primary generalized tonic clonic (PGTC) seizure frequency per 28 days Time to the first primary generalized tonic clonic (PGTC) seizure | — |
Countries
Australia, Belgium, Brazil, Bulgaria, Czech Republic, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Taiwan, Turkey, United States
Contacts
Public ContactClin Trial Reg & Results disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed