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

NCT02726074 | Completed Phase 4 Results

• 1 other identifier: E2007-M065-412
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 6

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).

Conditions

Epilepsy

Keywords

epilepsy; partial-onset seizures; secondarily generalized seizures

Outcome Measures

Primary Outcomes (1)

• 50 Percent (%) Responder Rate for Partial Onset Seizure With or Without Secondary Generalization

  The 50% responder rate was defined as the percentage of participants who achieved at least 50% reduction from baseline in the frequency of partial onset seizure with or without secondary generalization during the Maintenance Period.

  Baseline up to Week 36

Secondary Outcomes (8)

• 75% Responder Rate for Partial Onset Seizure With or Without Secondary Generalization

  Baseline up to Week 36

• 100% Responder Rate (Seizure Free Rate) for Partial Onset Seizure With or Without Secondary Generalization

  Baseline up to Week 36

• Percent Change From Baseline in Partial Onset Seizure Frequency With or Without Secondary Generalization to the Titration and Maintenance Period

  Weeks 12 and 36

• 50% Responder Rate in Secondary Generalized Tonic Clonic (GTC) Seizures

  Baseline up to Week 36

• 75% Responder Rate in Secondary GTC Seizures

  Baseline up to Week 36

Study Arms (1)

Perampanel 12 mg

EXPERIMENTAL

During the Titration Period, participants will receive 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.

Drug: Perampanel

Interventions

Perampanel DRUG

Also known as: E2007

Perampanel 12 mg

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Korea Inc.: lead

Study Sites (6)

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Daejeon, South Korea

Location

Unknown Facility

Gwangju, South Korea

Location

Unknown Facility

Seongnam, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Epilepsy

Interventions

perampanel

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Eisai Korea Inc. Medical department
• Organization: Eisai Inc.

h3-park@eisaikorea.com

+82-2-3451-5539

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: April 1, 2016
• Study Start: May 3, 2016
• Primary Completion: April 26, 2018
• Study Completion: April 26, 2018
• Last Updated: February 5, 2020
• Results First Posted: February 5, 2020

Record last verified: 2019-12

Locations

KR (6)