Clinical trial NCT02033902: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Epilepsy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-13
Enrollment: 500
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Epilepsy patients prescribed adjunctive treatment in countries where perampanel has received marketing approval. Multiple treating physicians will prescribe perampanel to patients, who then will be observed for approximately 52 weeks.

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.

Eligibility 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

Primary outcomes:
measure: Number of Treatment Emergent Adverse Events (TEAEs) of interest
timeFrame: Up to 52 weeks and 2 weeks of follow-up
Secondary outcomes:
measure: Incidence of unintended pregnancy
timeFrame: Up to 52 weeks
measure: Incidence of off-label use
timeFrame: Up to 52 weeks
measure: Summary scores for the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Screening, Week 52
measure: Number of TEAEs in the patient subpopulations of interest
timeFrame: Up to 52 weeks and 2 weeks of follow-up
measure: Clinical Global Impression of Change
timeFrame: Week 52
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Universitatsklinikum Innsbruck
city: Linz
country: Austria
facility: Kepler Universitätsklinikum
city: Wien
country: Austria
facility: Krankenhaus Wien-Hietzing
city: Battice
country: Belgium
facility: Eisai Site# 2405
city: Bruxelles
country: Belgium
facility: Hôpital Erasme
city: Bruxelles
country: Belgium
facility: Eisai Site# 2404
city: Duffel
country: Belgium
facility: Eisai Site# 2406
city: Leuven
country: Belgium
facility: Uz Leuven
city: Liège
country: Belgium
facility: Eisai Site# 2409
city: Ottignies
country: Belgium
facility: Eisai Site# 2403
city: Ruddershove
country: Belgium
facility: Eisai Site# 2408
city: Woluwe-Saint-Lambert
country: Belgium
facility: Eisai Site# 2407
city: Yvoir
country: Belgium
facility: Eisai Site# 2402
city: Beroun
country: Czechia
facility: Eisai Site# 2601
city: Brno
country: Czechia
facility: Eisai Site# 2600
city: Hradec Králové
country: Czechia
facility: Eisai Site# 2606
city: Náchod
country: Czechia
facility: Eisai Site# 2602
city: Ostrava
country: Czechia
facility: Cerebrovaskularni Poradna S.R.O.
city: Praha
country: Czechia
facility: Eisai Site# 2603
city: Be'er Sheva
country: Israel
facility: Eisai Site# 2013
city: Haifa
country: Israel
facility: Rambam Medical Center
city: H̱olon
country: Israel
facility: Edith Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Kiryat Hadassah
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Nahariya
country: Israel
facility: Western Galilee Hospital
city: Petach Tikva
country: Israel
facility: Schneider Children's Medical Center Of Israel
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Tel Aviv-Yafo
country: Israel
facility: Eisai Site# 2003
city: Tel Aviv-Yafo
country: Israel
facility: Eisai Site# 2012
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
city: Tel-Hashomer
country: Israel
facility: Eisai Site# 2008
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Linköping
country: Sweden
facility: Universitetssjukhuset I Linköping
city: Bristol
country: United Kingdom
facility: Eisai Site# 1607
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Lincoln
country: United Kingdom
facility: Eisai Site# 1611
city: London
country: United Kingdom
facility: Eisai Site# 1604
city: London
country: United Kingdom
facility: Eisai Site# 1608
city: London
country: United Kingdom
facility: Eisai Site# 1609
city: London
country: United Kingdom
facility: Great Ormond Street hospital
city: Newcastle
country: United Kingdom
facility: Eisai Site# 1612
city: Truro
country: United Kingdom
facility: Eisai Site# 1606
Study officials:
References:
citation: Maguire M. Response to "Perampanel and pregnancy: Could experience be a gloomy lantern that does not even illuminate its bearer?". Epilepsy Behav. 2022 Apr;129:108654. doi: 10.1016/j.yebeh.2022.108654. Epub 2022 Mar 16. No abstract available.
citation: Maguire M, Ben-Menachem E, Patten A, Malhotra M, Ngo LY. A post-approval observational study to evaluate the safety and tolerability of perampanel as an add-on therapy in adolescent, adult, and elderly patients with epilepsy. Epilepsy Behav. 2022 Jan;126:108483. doi: 10.1016/j.yebeh.2021.108483. Epub 2021 Dec 23.