Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset Seizures (NCT01147003) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset Seizures
United States93 participantsStarted 2010-06
Plain-language summary
This study will assess the efficacy and safety of BGG492 as adjunctive treatment in patients with partial onset seizures.
Who can participate
Age range18 Years – 65 Years
SexALL
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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
What they're measuring
1
To detect a dose-response by measuring the percent change in seizure frequency of BGG492 from baseline to maintenance period.