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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

500

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jun 2014

Typical duration for all trials

Geographic Reach

6 countries

42 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.7 years study duration

First Submitted

Initial submission to the registry

December 17, 2013

Completed

27 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed

5 months until next milestone

Study Start

First participant enrolled

June 6, 2014

Completed

3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed

Last Updated

September 7, 2018

Status Verified

November 1, 2015

Enrollment Period

3.7 years

First QC Date

December 17, 2013

Last Update Submit

September 6, 2018

Conditions

Epilepsy

Keywords

Epilepsy

Outcome Measures

Primary Outcomes (1)

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 Outcomes (5)

Incidence of unintended pregnancy
Up to 52 weeks
Incidence of off-label use
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
Clinical Global Impression of Change
Week 52

Study Arms (1)

Perampanel

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

Drug: Perampanel

Interventions

PerampanelDRUG

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

Perampanel

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

Male or female patients age greater than or equal to 12 years (or as regionally appropriate) at the time of informed consent
Patients prescribed perampanel for the adjunctive treatment of epilepsy within 7 days of the Screening Visit
Patients who provide informed consent

You may not qualify if:

Participation in another study involving administration of an investigational drug or device whilst participating in this observational study
Prior participation in a perampanel clinical study
Hypersensitivity to perampanel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eisai Inc.lead

Study Sites (42)

Universitatsklinikum Innsbruck

Innsbruck, 6020, Austria

Location

Kepler Universitätsklinikum

Linz, 4020, Austria

Location

Krankenhaus Wien-Hietzing

Vienna, 1130, Austria

Location

Eisai Site# 2405

Battice, Belgium

Location

Hôpital Erasme

Brussels, 1070, Belgium

Location

Eisai Site# 2404

Brussels, Belgium

Location

Eisai Site# 2406

Duffel, Belgium

Location

Uz Leuven

Leuven, 3000, Belgium

Location

Eisai Site# 2409

Liège, Belgium

Location

Eisai Site# 2403

Ottignies, Belgium

Location

Eisai Site# 2408

Ruddershove, Belgium

Location

Eisai Site# 2407

Woluwe-Saint-Lambert, Belgium

Location

Eisai Site# 2402

Yvoir, Belgium

Location

Eisai Site# 2601

Beroun, Czechia

Location

Eisai Site# 2600

Brno, Czechia

Location

Eisai Site# 2606

Hradec Králové, Czechia

Location

Eisai Site# 2602

Náchod, Czechia

Location

Cerebrovaskularni Poradna S.R.O.

Ostrava, 72200, Czechia

Location

Eisai Site# 2603

Prague, Czechia

Location

Eisai Site# 2013

Beersheba, Israel

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Edith Wolfson Medical Center

Holon, 58100, Israel

Location

Kiryat Hadassah

Jerusalem, Israel

Location

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

Western Galilee Hospital

Nahariya, 22100, Israel

Location

Schneider Children's Medical Center Of Israel

Petah Tikva, 49202, Israel

Location

The Chaim Sheba Medical Center

Ramat Gan, Israel

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Eisai Site# 2003

Tel Aviv, Israel

Location

Eisai Site# 2012

Tel Aviv, Israel

Location

Eisai Site# 2008

Tel Litwinsky, Israel

Location

Sahlgrenska Universitetssjukhuset

Gothenburg, SE-41345, Sweden

Location

Universitetssjukhuset I Linköping

Linköping, 58185, Sweden

Location

Eisai Site# 1607

Bristol, United Kingdom

Location

Ninewells Hospital

Dundee, Dd1 9Sy, United Kingdom

Location

Eisai Site# 1611

Lincoln, United Kingdom

Location

Eisai Site# 1604

London, United Kingdom

Location

Eisai Site# 1608

London, United Kingdom

Location

Eisai Site# 1609

London, United Kingdom

Location

Great Ormond Street hospital

London, United Kingdom

Location

Eisai Site# 1612

Newcastle, United Kingdom

Location

Eisai Site# 1606

Truro, United Kingdom

Location

Related Publications (2)

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.
PMID: 35305920DERIVED
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.
PMID: 34953337DERIVED

MeSH Terms

Conditions

Epilepsy

Interventions

perampanel

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 17, 2013

First Posted

January 13, 2014

Study Start

June 6, 2014

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

September 7, 2018

Record last verified: 2015-11

Locations

GB(9)SE(2)CZ(6)AU(3)BE(10)IL(12)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Perampanel

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (42)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Locations