A Study to Evaluate the Safety and Efficacy of Fycompa® (Perampanel) as Add-on Therapy in Participants With Epilepsy

NCT ID: NCT04230044

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 117 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-11
• Study Completion Date: 2017-07-03

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of Fycompa® (perampanel) for the adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy aged 12 years and older.

Conditions

Epilepsy; Partial-onset Seizures

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Fycompa® (perampanel)

Fycompa® (perampanel) (oral tablets) treatment will be initiated at 2 milligram (mg) once daily according to the approved package insert, as an add-on drug in addition to other anti-epileptic drugs (AEDs) as prescribed by physician. The dose will be increased based on clinical response and tolerability (by increments of 2 mg/day to a maintenance dose of 4 to 12 mg/day) and participants will be enrolled and observed prospectively for up to 54 Weeks.

Perampanel

Intervention Type: DRUG

Perampanel tablets.

Interventions

Perampanel

Perampanel tablets.

Intervention Type: DRUG

Other Intervention Names

Fycompa; E2007

Eligibility Criteria

Inclusion Criteria

1. Male and female participants aged 12 years and older

2. Participants who were diagnosed with partial-onset seizures with or without secondarily generalized seizures.

3. Participants who were appropriate to receive Fycompa® as an adjunctive treatment participants starting at Visit 0 according to investigator's judgment.

4. Participants who had provided written informed consent

Exclusion Criteria

1. Participants not fit to receive Fycompa® as per the latest prescribing information.

2. Participants who were participating in a clinical trial, at the time of the study.

3. Participants who showed evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, renal disease, etc.) that in the opinion of the Investigators could affect the participant's safety or trial conduct.

4. Participants who according to the Investigators would not be able to comply with study procedures.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

E2007-M065-411

Identifier Type: -

Identifier Source: org_study_id