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-SK
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 81
Key inclusion criteria:
- male or female
- weight sup or equal to 50kg
- have a diagnosis of epilepsy ( For Cohort 1 abnormal EEG more than 2 years prior to screening) with partial seizures with or without secondarily generalizations seizures. For Cohort 2 the abnormal EEG at any time prior to screening.
- have uncontrolled partial seizures
- have at least 4 partial seizures
- have no 28-day seizure-free period during the 8 weeks preceding randomization
- Cohort 1 pstients must be receiving stable treatment with 1 or a maximum of 2 AEDs, whereas Cohort 2 patients must be receiving stable treatment with 1, 2 or 3 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 within 52 weeks prior to screening
- 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
For other criteria, please refer to the Protocol.
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