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

Completed

• Conditions: Epilepsy
• Interventions: Drug: Perampanel

• Registration Number: NCT02033902
• Lead Sponsor: Eisai Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-12-17
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-13
• Study Start: 2014-06-06
• Status Verified: 2015-11
• Primary Completion: 2018-01-31
• Study Completion: 2018-01-31
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Treatment Emergent Adverse Events (TEAEs) of interest	Up to 52 weeks and 2 weeks of follow-up	Assessment of events of dizziness, blurred vision, somnolence, aggression, balance disorders, ataxia, falls, unintended pregnancy, weight gain, suicidality, drug abuse, misuse, dependence, withdrawal, off-label use, skin photosensitivity, unintended pregnancy while taking levonorgestrel-containing contraceptives, and outcomes associated with any suspected drug-drug interaction.

Secondary Outcome Measures

Name	Time	Method
Incidence of unintended pregnancy	Up to 52 weeks
Summary scores for the Hospital Anxiety and Depression Scale (HADS)	Screening, Week 52
Number of TEAEs in the patient subpopulations of interest	Up to 52 weeks and 2 weeks of follow-up	TEAEs observed in the specified subpopulations of patients could also be made in order to get a better understanding of whether any of these particular potential risk factors (e.g., old age, cardiovascular disease) define groups with greater or lesser risk.
Clinical Global Impression of Change	Week 52	Assessment of disease severity will utilize the Clinical Global Impression of Change (CGI-C) scale at end of treatment to evaluate change in disease status since initiation of treatment.
Incidence of off-label use	Up to 52 weeks

Trial Locations

Locations (42)

Universitatsklinikum Innsbruck; 🇦🇹 Innsbruck, Austria

Kepler Universitätsklinikum; 🇦🇹 Linz, Austria

Krankenhaus Wien-Hietzing; 🇦🇹 Wien, Austria

Eisai Site# 2405; 🇧🇪 Battice, Belgium

Hôpital Erasme; 🇧🇪 Bruxelles, Belgium

Eisai Site# 2404; 🇧🇪 Bruxelles, Belgium

Eisai Site# 2406; 🇧🇪 Duffel, Belgium

Uz Leuven; 🇧🇪 Leuven, Belgium

Eisai Site# 2409; 🇧🇪 Liège, Belgium

Eisai Site# 2403; 🇧🇪 Ottignies, Belgium

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