A study to assess the safety and efficacy of Lacosamide versus placebo (a pill without active medication) in patients with idiopathic generalised epilepsy who are already taking anti-epileptic medications
- Conditions
- EpilepsyMedDRA version: 20.0 Level: LLT Classification code 10071096 Term: Idiopathic generalized epilepsy System Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2011-003100-21-SK
- Lead Sponsor
- CB BIOSCIENCES, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 250
• 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) with no benzodiazepine AEDs OR 1 benzodiazepine marketed AED with 1 to 2 non-benzodiazepine marketed AEDs 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: 60
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
• Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide (LCM)
• Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious adverse event (SAE)
•Subject has >=2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (>=1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%).
• History of partial onset seizures or EEG findings indicating partial onset seizures
• Symptomatic generalized epilepsy, (eg, Lennox-Gastaut Syndrome
typically presenting with seizures including tonic seizures), some other related syndrome like Doose’s syndrome (typically presenting with myoclonic-atonic seizures) or evidence of both focal and generalized epilepsy.
• 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 clozapine, monoamine oxidase A (MAO-A) 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 that has either changed within the 4 weeks prior to Visit 1 or is expected to change during the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method