Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Novartis
• Treatments: Anticonvulsants

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 AEDs within the last 2 years prior to screening.

• Treated with a stable dose of 1-2 AEDs

• 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.

• No 28-day seizure-free period during the 8 weeks preceding randomization

• Positive biomarker screening

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

• Pregnant or nursing (lactating) women

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

Other protocol-defined inclusion/exclusion criteria may apply