Trial Evaluating the Efficacy and Safety of Perampanel Added to Monotherapy in Participants With Partial Onset Seizures With or Without Secondary Generalization

• Status: Completed
• Trial end date: 2018-04-26
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Korea Inc.

Criteria

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 Visit 1 (Week 0)

• Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors

• Concomitant use of barbiturates (except for seizure control indication and premedication for electroencephalogram [EEG]) and benzodiazepines (except for seizure control indication) within 8 weeks prior to Visit 1 (Week 0)

• Use of intermittent rescue benzodiazepines (that is, 1 to 2 doses over a 24-hr period considered one-time rescue) 2 or more times in an 8-week period prior to Visit 1 (Week 0)

• Participant who is participating in other intervention clinical trial