A 12-week, Randomized, Double-blind, Placebo-controlled Exploratory Study to Assess the Antiepileptic Activity of BGG492 Given Orally as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures

ovartis Health care Private Limited0 sites57 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Sponsor

ovartis Health care Private Limited

•Male and female outpatients age 18 to 65 years (inclusive)
•2\. Weight of greater than or equal to 50 kg (110 lb)
•3\. Have a diagnosis of epilepsy (more than 2 years before screening) with partial seizures
•with or without secondarily generalized seizures according to the International League
•Against Epilepsys Classification of Epileptic Seizures (ILAE, 1981\) Appendix 5
•The Diagnosis should have been established by clinical history and electroencephalogram
•(EEG) that is consistent with localization related epilepsy
•4\. Must have at least 4 partial seizures (defined as simple partial seizures with motor signs,
•complex partial seizures, complex partial seizures with secondary generalization or a
•combination of these types) during the 4 week baseline period and the 4 weeks

•\* Presence of only non\-motor simple partial seizures
•\* History of psychogenic seizures
•\* Absences, myoclonic seizures e.g. in the context of primary generalized epilepsy;
•\* Previous history of Lennox\-Gastaut syndrome
•\*Pregnant or nursing (lactating) women
•\* Status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization

Not specified