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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02033902
• Other study ID #: E2007-G000-402
• Status: Completed
• Start date: June 6, 2014
• Est. completion date: January 31, 2018

Study information

• Verified date: November 2015
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

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

Locations

Country	Name	City	State
Austria	Universitatsklinikum Innsbruck	Innsbruck
Austria	Kepler Universitätsklinikum	Linz
Austria	Krankenhaus Wien-Hietzing	Wien
Belgium	Eisai Site# 2405	Battice
Belgium	Eisai Site# 2404	Bruxelles
Belgium	Hôpital Erasme	Bruxelles
Belgium	Eisai Site# 2406	Duffel
Belgium	Uz Leuven	Leuven
Belgium	Eisai Site# 2409	Liège
Belgium	Eisai Site# 2403	Ottignies
Belgium	Eisai Site# 2408	Ruddershove
Belgium	Eisai Site# 2407	Woluwe-Saint-Lambert
Belgium	Eisai Site# 2402	Yvoir
Czechia	Eisai Site# 2601	Beroun
Czechia	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# 2603	Praha
Israel	Eisai Site# 2013	Be'er Sheva
Israel	Edith Wolfson Medical Center	H_olon
Israel	Rambam Medical Center	Haifa
Israel	Kiryat Hadassah	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Israel	Western Galilee Hospital	Nahariya
Israel	Schneider Children's Medical Center Of Israel	Petach Tikva
Israel	The Chaim Sheba Medical Center	Ramat Gan
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv
Israel	Eisai Site# 2003	Tel Aviv-Yafo
Israel	Eisai Site# 2012	Tel Aviv-Yafo
Israel	Eisai Site# 2008	Tel-Hashomer
Sweden	Sahlgrenska Universitetssjukhuset	Göteborg
Sweden	Universitetssjukhuset I Linköping	Linköping
United Kingdom	Eisai Site# 1607	Bristol
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	Eisai Site# 1611	Lincoln
United Kingdom	Eisai Site# 1604	London
United Kingdom	Eisai Site# 1608	London
United Kingdom	Eisai Site# 1609	London
United Kingdom	Great Ormond Street hospital	London
United Kingdom	Eisai Site# 1612	Newcastle
United Kingdom	Eisai Site# 1606	Truro

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Countries where clinical trial is conducted

Austria,  Belgium,  Czechia,  Israel,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Treatment Emergent Adverse Events (TEAEs) of interest	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.	Up to 52 weeks and 2 weeks of follow-up
Secondary	Incidence of unintended pregnancy		Up to 52 weeks
Secondary	Incidence of off-label use		Up to 52 weeks
Secondary	Summary scores for the Hospital Anxiety and Depression Scale (HADS)		Screening, Week 52
Secondary	Number of TEAEs in the patient subpopulations of interest	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.	Up to 52 weeks and 2 weeks of follow-up
Secondary	Clinical Global Impression of Change	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.	Week 52