Status:
WITHDRAWN
Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures
Lead Sponsor:
Novartis
Conditions:
Partial Onset Seizures
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will assess the efficacy of BGG492 as adjunctive treatment in patients with refractory partial onset seizures
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01167335
Start Date
August 1 2010
Last Update
May 1 2012
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
University of South Alabama
Mobile, Alabama, United States, 36693
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
3
Epilepsy Care Specialists, S.C.
Milwaukee, Wisconsin, United States, 53215
4
Novartis Investigative Site
Salzburg, Austria, A-5020