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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Not provided
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)
Eisai Site# 1606
🇬🇧Truro, United Kingdom
Universitatsklinikum Innsbruck
🇦🇹Innsbruck, Austria
Kepler Universitätsklinikum
🇦🇹Linz, Austria
Krankenhaus Wien-Hietzing
🇦🇹Wien, Austria
Uz Leuven
🇧🇪Leuven, Belgium
Meir Medical Center
🇮🇱Kfar Saba, Israel
Eisai Site# 2406
🇧🇪Duffel, Belgium
Hôpital Erasme
🇧🇪Bruxelles, Belgium
Eisai Site# 2405
🇧🇪Battice, Belgium
Eisai Site# 2404
🇧🇪Bruxelles, Belgium
Eisai Site# 2601
🇨🇿Beroun, Czechia
Eisai Site# 2409
🇧🇪Liège, Belgium
Eisai Site# 2408
🇧🇪Ruddershove, Belgium
Eisai Site# 2407
🇧🇪Woluwe-Saint-Lambert, Belgium
Eisai Site# 2402
🇧🇪Yvoir, Belgium
Eisai Site# 2403
🇧🇪Ottignies, Belgium
Eisai Site# 2600
🇨🇿Brno, Czechia
Eisai Site# 2606
🇨🇿Hradec Králové, Czechia
Eisai Site# 2602
🇨🇿Náchod, Czechia
Cerebrovaskularni Poradna S.R.O.
🇨🇿Ostrava, Czechia
Eisai Site# 2013
🇮🇱Be'er Sheva, Israel
Eisai Site# 2603
🇨🇿Praha, Czechia
Rambam Medical Center
🇮🇱Haifa, Israel
Edith Wolfson Medical Center
🇮🇱H̱olon, Israel
Kiryat Hadassah
🇮🇱Jerusalem, Israel
Schneider Children's Medical Center Of Israel
🇮🇱Petach Tikva, Israel
Western Galilee Hospital
🇮🇱Nahariya, Israel
The Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
Eisai Site# 2003
🇮🇱Tel Aviv-Yafo, Israel
Eisai Site# 2012
🇮🇱Tel Aviv-Yafo, Israel
Tel-Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Sahlgrenska Universitetssjukhuset
🇸🇪Göteborg, Sweden
Eisai Site# 2008
🇮🇱Tel-Hashomer, Israel
Universitetssjukhuset I Linköping
🇸🇪Linköping, Sweden
Eisai Site# 1607
🇬🇧Bristol, United Kingdom
Ninewells Hospital
🇬🇧Dundee, United Kingdom
Eisai Site# 1611
🇬🇧Lincoln, United Kingdom
Eisai Site# 1609
🇬🇧London, United Kingdom
Eisai Site# 1604
🇬🇧London, United Kingdom
Eisai Site# 1608
🇬🇧London, United Kingdom
Great Ormond Street hospital
🇬🇧London, United Kingdom
Eisai Site# 1612
🇬🇧Newcastle, United Kingdom