A Global, Postmarketing Observational Safety Study to Evaluate the Safety and Tolerability of Fycompa (Perampanel) as Add-on Therapy in Epilepsy Patients Aged Greater Than or Equal to 12 Years

Eisai

Status: Completed

Conditions: Epilepsy

Treatments: Drug: Perampanel

Study type: Observational

Funder types: Industry

Identifiers

NCT02033902

E2007-G000-402

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of Fycompa (Perampanel) as an add-on therapy in epilepsy patients aged greater than or equal to 12 years.

Full description

This is a global, observational, cohort study in patients with epilepsy. Multiple treating physicians will prescribe perampanel to approximately 500 patients, who then will be observed for approximately 52 weeks.

Enrollment: 500 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Male or female patients age greater than or equal to 12 years (or as regionally appropriate) at the time of informed consent
2. Patients prescribed perampanel for the adjunctive treatment of epilepsy within 7 days of the Screening Visit
3. Patients who provide informed consent

Exclusion Criteria

1. Participation in another study involving administration of an investigational drug or device whilst participating in this observational study
2. Prior participation in a perampanel clinical study
3. Hypersensitivity to perampanel

Trial design

500 participants in 1 patient group

Perampanel

Description:

Perampanel tablets are administered orally according to prescribing information and the treating physician's clinical judgment

Treatment:

Drug: Perampanel