Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset Seizures
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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 :
Resource links provided by the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 65 Years (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