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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Matsuyama, Ehime, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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]).

Exclusion criteria

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.

Treatment and study plan

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.

Other names: Fycompa, E2007

Primary outcomes

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

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

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.

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Apr 28, 2015
Registry last updated: Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed