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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

NCT ID: NCT02033902

Last Updated: 2018-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-06

Study Completion Date

2018-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Epilepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Perampanel

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

Perampanel

Intervention Type DRUG

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

Interventions

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Perampanel

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitatsklinikum Innsbruck

Innsbruck, , Austria

Site Status

Kepler Universitätsklinikum

Linz, , Austria

Site Status

Krankenhaus Wien-Hietzing

Vienna, , Austria

Site Status

Eisai Site# 2405

Battice, , Belgium

Site Status

Hôpital Erasme

Brussels, , Belgium

Site Status

Eisai Site# 2404

Brussels, , Belgium

Site Status

Eisai Site# 2406

Duffel, , Belgium

Site Status

Uz Leuven

Leuven, , Belgium

Site Status

Eisai Site# 2409

Liège, , Belgium

Site Status

Eisai Site# 2403

Ottignies, , Belgium

Site Status

Eisai Site# 2408

Ruddershove, , Belgium

Site Status

Eisai Site# 2407

Woluwe-Saint-Lambert, , Belgium

Site Status

Eisai Site# 2402

Yvoir, , Belgium

Site Status

Eisai Site# 2601

Beroun, , Czechia

Site Status

Eisai Site# 2600

Brno, , Czechia

Site Status

Eisai Site# 2606

Hradec Králové, , Czechia

Site Status

Eisai Site# 2602

Náchod, , Czechia

Site Status

Cerebrovaskularni Poradna S.R.O.

Ostrava, , Czechia

Site Status

Eisai Site# 2603

Prague, , Czechia

Site Status

Eisai Site# 2013

Beersheba, , Israel

Site Status

Rambam Medical Center

Haifa, , Israel

Site Status

Edith Wolfson Medical Center

Holon, , Israel

Site Status

Kiryat Hadassah

Jerusalem, , Israel

Site Status

Meir Medical Center

Kfar Saba, , Israel

Site Status

Western Galilee Hospital

Nahariya, , Israel

Site Status

Schneider Children's Medical Center Of Israel

Petah Tikva, , Israel

Site Status

The Chaim Sheba Medical Center

Ramat Gan, , Israel

Site Status

Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Eisai Site# 2003

Tel Aviv, , Israel

Site Status

Eisai Site# 2012

Tel Aviv, , Israel

Site Status

Eisai Site# 2008

Tel Litwinsky, , Israel

Site Status

Sahlgrenska Universitetssjukhuset

Gothenburg, , Sweden

Site Status

Universitetssjukhuset I Linköping

Linköping, , Sweden

Site Status

Eisai Site# 1607

Bristol, , United Kingdom

Site Status

Ninewells Hospital

Dundee, , United Kingdom

Site Status

Eisai Site# 1611

Lincoln, , United Kingdom

Site Status

Eisai Site# 1604

London, , United Kingdom

Site Status

Eisai Site# 1608

London, , United Kingdom

Site Status

Eisai Site# 1609

London, , United Kingdom

Site Status

Great Ormond Street hospital

London, , United Kingdom

Site Status

Eisai Site# 1612

Newcastle, , United Kingdom

Site Status

Eisai Site# 1606

Truro, , United Kingdom

Site Status

Countries

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Austria Belgium Czechia Israel Sweden United Kingdom

References

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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.

Reference Type DERIVED
PMID: 35305920 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34953337 (View on PubMed)

Other Identifiers

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E2007-G000-402

Identifier Type: -

Identifier Source: org_study_id

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