Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset Seizures

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the efficacy and safety of BGG492 as adjunctive treatment in patients with partial onset seizures.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis

Criteria

Inclusion Criteria:

• Outpatients ≥ 50 kg (110 lb) of weight.

• A diagnosis of epilepsy (≥ 2 years prior to screening) with partial seizures with or without secondarily generalized seizures.

• Uncontrolled partial seizures despite having been treated with at least two different antiepileptic drugs (AEDs) within the last 2 years prior to screening.

• At least 4 partial seizures during the 4-week baseline period and at least 4 partial seizures during the 4 weeks prior to the baseline period.

• Cohort 1 patients must be receiving stable treatment with 1 or a maximum of 2 AEDs.Cohort 2 patients must be receiving stable treatment with 1, 2, or 3 AEDs.

Exclusion Criteria:

• 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.

• Status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization.

• Pregnant or nursing (lactating) women.

Other protocol-defined inclusion/exclusion criteria may apply