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

Phase 1

• Conditions: Epilepsy; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-004945-10-Outside-EU/EEA
• Lead Sponsor: Eisai Co., ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-30
• Last Update Posted: 4 September 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

1. 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).
2. 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.
3. 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]).

Are the trial subjects under 18? yes
Number of subjects for this age range: 11
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified