Status:
COMPLETED
Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With 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 and safety of BGG492 as adjunctive treatment in patients with 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 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT01147003
Start Date
June 1 2010
End Date
September 1 2011
Last Update
December 17 2020
Active Locations (51)
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1
Barrow Neurological Clinics at St. Joseph's Hospital and MC
Phoenix, Arizona, United States, 85013
2
Center for Neurosciences
Tucson, Arizona, United States, 85718
3
Clinical Trials, Inc.
Little Rock, Arkansas, United States, 72205
4
Medical Center of the Rockies
Loveland, Colorado, United States, 80538