Trial Evaluating the Efficacy and Safety of Perampanel Added to Monotherapy in Participants With … (NCT02726074) | Clinical Trial Compass
CompletedPhase 4
Trial Evaluating the Efficacy and Safety of Perampanel Added to Monotherapy in Participants With Partial Onset Seizures With or Without Secondary Generalization
South Korea106 participantsStarted 2016-05-03
Plain-language summary
This is a multi-center, open-label, single-arm, phase 4 study to evaluate the efficacy of perampanel added to monotherapy for partial onset seizures with or without secondarily generalized seizures (total seizures).
Who can participate
Age range12 Years
SexALL
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Inclusion Criteria:
* Have a diagnosis of epilepsy with partial onset seizures with or without secondarily generalized seizures according to the International League Against Epilepsy's Classification of Epileptic Seizures (1981)
* Need an initial add-on therapy after failure to control seizures with the first or further monotherapy at the optimal dose and duration
* Despite antiepileptic drug (AED) treatment within the last 8 weeks, participants must have had greater than or equal to 2 partial onset seizures, and the interval between those seizures should be more than 24 hours prior to Visit 1 (Week 0).
* Are currently being treated with stable doses of monotherapy for 8 weeks prior to Visit 1 (Week 0) (Standard AEDs)
* If antidepressants or antianxiety drugs are used, participants must be receiving stable doses and administrations of antidepressants or antianxiety drugs for 8 weeks prior to Visit 1 (Week 0)
Exclusion Criteria:
* Females who are pregnant (positive beta-human chorionic gonadotropin (β-hCG test) or breastfeeding
* Presence of previous history of Lennox-Gastaut syndrome
* Presence of nonmotor simple partial seizures only
* Presence of primary generalized epilepsies or seizures such as absences and/or myoclonic epilepsies
* A history of status epilepticus within 12 weeks before Visit 1 (Week 0)
* Participants on antipsychotics or who have psychotic disorder(s) or unstable recurrent affective disorder(s) with a history of attempted suicide within 1 year before …
What they're measuring
1
50 Percent (%) Responder Rate for Partial Onset Seizure With or Without Secondary Generalization