Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset Seizures
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study Examining Seizure Frequency of BGG492 Capsules as Adjunctive Treatment in Patients With Partial Onset Seizures
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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