A 12-week, multi-center,randomized, double-blind, placebo-controlled efficacy and safety study examining seizure frequency of BGG492 capsules administration orally three times daily (TID) as adjunctive treatment in patients with partial onset seizures.
- Conditions
- refractory partial-onset seizuresMedDRA version: 12.1Level: LLTClassification code 10065336Term: Partial epilepsy
- Registration Number
- EUCTR2009-017961-52-HU
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Key inclusion criteria:
- male or female
- weight sup or equal to 50kg
- have a diagnosis of epilepsy ( more than 2 years prior to screening) with partial seizures with or without secondarily generalizations seizures
- have uncontrolled partial seizures
- have at least 4 partial seizures
- have no 28-day seizure-free period during the 8 weeks preceding randomization
- must be receiving stable treatment with 1 or a maximum of 2 AEDs
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Key exclusion criteria:Any of the following seizure conditions:
- Presence of only non-motor simple partial seizures
- Pschogenic seizures
- Absences and/or myoclonic seizures e.g. in the context of primarily generalized epilepsy
- Previous history of Lennox-Gastaut syndrome
- Status epilepticus or seizure clusters where individual seizures cannot be counted according to the judgement of the investigator occuring within 52 weeks prior to randomization.
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