epilepsy MedDRA version: 12.1 Level: LLT Classification code 10015037 Term: Epilepsy
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - male&female outpatients age 18 to 65 years - weight sup or equal to 50 kg - have a diagnosis of epilepsy (more than 2 years before screening) with partial seizures - must have at least 4 partial seizures during the 4-week baseline period and the 4 weeks immediately preceding the baseline period - have no 28-day seizure-free period during the 8 weeks preceding randomization - must have a positive test result for iGluR3 antibodies in the blood at screening - must have uncontrolled partial seizures despite having been treated with at least two different anti-epileptic drugs within the last 2 years prior to screening - must have received stable treatment with 1 or a max of 2 AED.... 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
Exclusion criteria
Exclusion criteria: 1. Any of the following seizure conditions: - presence of only non-motor simple partial seizures - history of psychogenic seizure - abscences, myoclonic seizures - previous history of Lennox-Gastaut syndrome - history of status epilepticus or seizure clusters - only seizures caused by an underlying medical illness during the 52 weeks prior to randomization. 2. Have been treated with Vangabatrin, MAO inhibitors, Barbiturates, intermittent Benzodiazepines, L-dopa formulations, concomitant use of potential inhibitors of OATP transporters ....
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to evaluate efficacy of BGG492 100mg (administered orally TID) compared to placebo assessed as change in seizure frequency from the 4-week baseline period (Week -4 to -1) to the 100mg double-blind maintenance period (Week 7-10).;Secondary Objective: Secondary Objectives are to evaluate: - responder rate of BGG492 compared to Placebo during the 4-week BGG492 100mg double-blind maintenance period - the efficacy of BGG492 compared to placebo assessed as change in seizure frequency from the 4-week baseline period to the 50mg double-blind maintenance period - responder rate of BGG492 compared to Placebo during the 4-week BGG492 50mg double-blind maintenance period - the efficacy of BGG492 compared to placebo assessed as change in seizure frequency from the 4-week baseline period to the 10-week double-blind treatment evaluation phase - responder rate of BGG492 compared to Placebo during the 10-week double-blind treatment evaluation phase - the proportion of seizure-free patients on BGG492 capsules compared to placebo - PK of BGG492, all doses administered orally TID, in patients with partial onset seizures - plasma levels of concomitant AEDs before and at the end of the treatment ...;Primary end point(s): Seizure counts (partial seizures only) during the 28-day baseline period and the Weeks 7-10 maintenance period in comparison to placebo. | — |
Countries
Austria, Estonia, Latvia, Lithuania, Spain
Outcome results
None listed