An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects

NCT02427607 | Completed Phase 3 Results

• 1 other identifier: E2007-J000-341
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 8

Brief Summary

To evaluate the safety and tolerability of perampanel given as an adjunctive therapy in participants with epilepsy. This study will be continued until perampanel is commercially available.

Conditions

Epilepsy

Keywords

Epilepsy; Perampanel

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel

  Safety was assessed by monitoring adverse events (AEs), withdrawal from treatment, clinical laboratory tests (chemistry), vital signs, and weight. TEAEs were defined as AEs that emerged from the first dose of study drug to the last visit of Study 341 or on or after 30 days since the last dose of study drug in Study 341, whichever comes later, having been absent at pretreatment (Baseline of Study 332). A markedly abnormal clinical chemistry laboratory value was defined as a laboratory result that worsened in severity to meet modified National Cancer Institute (NCI) toxicity criteria of Grade 2 or higher on treatment. Treatment-related TEAEs were defined as AEs that were considered by the investigator to be possibly or probably related to study treatment. SAEs were defined as any untoward medical occurrence that at any dose; resulted in death, disability/incapacity, birth defect, required inpatient hospitalization or prolongation of existing hospitalization, or was life-threatening.

  From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months

Study Arms (1)

Perampanel

EXPERIMENTAL

Participants started the study with the dose that they were receiving at the end of their participation in the previously participated Study E2007-G000-332 (Study 332) \[NCT02307578\]. Doses of perampanel were allowed to be adjusted based on clinical judgment. A minimum perampanel dose of 2 milligram (mg) per day was required to continue in the study. The maximum daily dose of perampanel permitted was 12 mg per day.

Drug: Perampanel

Interventions

Perampanel DRUG

Perampanel 2 mg tablets. Doses of perampanel can be adjusted based on clinical judgment. A minimum perampanel dose of 2 mg per day is required to continue in the study. The maximum daily dose of perampanel permitted will be 12 mg per day.

Also known as: Fycompa, E2007

Perampanel

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:

• Participants participating in the designated perampanel study as below, and who in the opinion of the investigator continue to benefit from treatment with perampanel Designated perampanel study: E2007-G000-332 (NCT01393743) (with at least 52 weeks of total exposure to perampanel).
• Provide written informed consent/assent signed by participant or legal guardian prior to entering the study or undergoing any study procedures. If the written informed consent is provided by the legal guardian because the participant is unable to do so, a written or verbal assent from the participant must also be obtained.
• Female participants of childbearing potential must agree for the duration of the study and for a period of at least 1 month following the last dose of perampanel to be abstinent or to commit to the consistent and correct use of a medically acceptable method of birth control (eg, a double-barrier method \[condom plus spermicide, condom plus diaphragm with spermicide\]).

You may not qualify if:

• Participants residing in countries where perampanel is commercially available with respect to the indication or formulation of the designated perampanel study.
• Female participants who are nursing, pregnant, or planning to become pregnant.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (8)

Unknown Facility

Matsuyama, Ehime, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Inashiki-gun, Ibaraki, Japan

Location

Unknown Facility

Uji, Kyoto, Japan

Location

Unknown Facility

Sakai, Osaka, Japan

Location

Unknown Facility

Matsue, Shimane, Japan

Location

Unknown Facility

Nerima-Ku, Tokyo, Japan

Location

Unknown Facility

Niigata, Japan

Location

MeSH Terms

Conditions

Epilepsy

Interventions

perampanel

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Hidetaka Hiramatsu
• Organization: Eisai Co., Ltd.

esi_medinfo@eisai.com

+81-3-3817-5245

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: April 28, 2015
• Study Start: May 12, 2015
• Primary Completion: September 21, 2016
• Study Completion: November 9, 2016
• Last Updated: July 2, 2018
• Results First Posted: July 2, 2018

Record last verified: 2017-09

Locations

JP (8)