Clinical trial NCT02726074: Trial Evaluating the Efficacy and Safety of Perampanel Added to Monotherapy in Participants With Partial Onset Seizures With or Without Secondary Generalization
Official title: Multicenter, Open-label Trial Evaluating the Efficacy and Safety of Perampanel Added to Monotherapy in Patients With Partial Onset Seizures With or Without Secondary Generalization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Keywords: epilepsy
partial-onset seizures
secondarily generalized seizures
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-01
Enrollment: 106
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed description: This multi-center, open-label, single-arm study evaluating the efficacy of perampanel added to monotherapy for partial onset seizures consists of 2 periods: Titration Period (12 weeks) and Maintenance Period (24 weeks). During the Titration Period, participants will begin receiving perampanel 2 milligrams per day (mg/day) and be up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants will receive the last dose they achieved at the end of the Titration Period and will continue receiving this dose once daily for the remainder of the study.

Eligibility 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

Primary outcomes:
measure: 50 Percent (%) Responder Rate for Partial Onset Seizure With or Without Secondary Generalization
timeFrame: Baseline up to Week 36
Secondary outcomes:
measure: 75% Responder Rate for Partial Onset Seizure With or Without Secondary Generalization
timeFrame: Baseline up to Week 36
measure: 100% Responder Rate (Seizure Free Rate) for Partial Onset Seizure With or Without Secondary Generalization
timeFrame: Baseline up to Week 36
measure: Percent Change From Baseline in Partial Onset Seizure Frequency With or Without Secondary Generalization to the Titration and Maintenance Period
timeFrame: Weeks 12 and 36
measure: 50% Responder Rate in Secondary Generalized Tonic Clonic (GTC) Seizures
timeFrame: Baseline up to Week 36
measure: 75% Responder Rate in Secondary GTC Seizures
timeFrame: Baseline up to Week 36
measure: 100% Responder Rate (Seizure Free Rate) in Secondary GTC Seizures
timeFrame: Baseline up to Week 36
measure: Percent Change From Baseline in Secondary GTC Seizure Frequency to the Titration and Maintenance Period
timeFrame: Weeks 12 and 36
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: From the first dose of investigational product to the last visit or 28 days after the last dose (up to 1 year 11 months)
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Seongnam
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
References: