refractory partial-onset seizures MedDRA version: 12.1 Level: LLT Classification code 10065336 Term: Partial epilepsy
Conditions
Interventions
Product Code: BGG492
Pharmaceutical Form: Capsule, hard
Current Sponsor code: BGG492
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the p
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key inclusion criteria: - male or female - weight sup or equal to 50kg - Have a diagnosis of epilepsy (= 2 years prior to screening) with partial seizures with or without secondarily generalized seizures according to the International League Against Epilepsy’s Classification of Epileptic Seizures (ILAE, 1981); Appendix 5; The diagnosis should have been established by clinical history and abnormal electroencephalogram (EEG) that is consistent with localization-related epilepsy (For Cohort 1 an abnormal EEG must be dated > 2 years prior screening for inclusion. For Cohort 2, an abnormal EEG is acceptable at any time prior to screening provided that clinical history documents localization-related epilepsy along with AED treatment for > 2 years 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 patients must be receiving stable treatment (see inclusion criteria 8.1-8.4 and 9) with 1 or a maximum of 2 AEDs ; whereas, Cohort 2 patients must be receiving stable treatment with 1, 2, or 3 AEDs please refer to protocol for the full list 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: Key exclusion criteria:Any of the following seizure conditions: - Presence of only non-motor simple partial seizures - History of psychogenic 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. please refert to protocol for the full list
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to detect a dose-response of BGG492 (administered orally TID) as measured by change in seizure frequency from the 4-week baseline period (Weeks -4 to -1) to the 4-week double-blind maintenance period (Weeks 7 to 10).;Secondary Objective: The key secondary objective is to evaluate the efficacy of BGG492 (100mg, 150 mg) administered orally TID compared to placebo assessed as change in seizure frequency from the 4-week baseline period (Weeks -4 to -1) to the 4-week double-blind maintenance period (Weeks 7 to 10).;Primary end point(s): primary efficacy assessment: seizure counts (partial seizures only)during the 28-day baseline period and the week 7-10 maintenance period in comparison to placebo. | — |
Countries
Germany, Hungary, Italy, Slovakia
Outcome results
None listed