Perampanel

Generic Name: Perampanel

Brand Names: Fycompa

Drug Type: Small Molecule

Chemical Formula: C_₂₃H_₁₅N_₃O

CAS Number: 380917-97-5

Unique Ingredient Identifier: H821664NPK

Background: Perampanel is a noncompetitive AMPA glutamate receptor antagonist. It is marketed under the name Fycompa™ and is indicated as an adjunct in patients over 12 years old for the treatment of partial-onset seizures that may or may not occur with generalized seizures. The FDA label includes an important black-boxed warning of serious or life-threatening behaviora...

Indication: Perampanel is indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in epileptic patients four years of age and older. It is also indicated as an adjunct in the treatment of primary generalized tonic-clonic seizures in epileptic patients aged 12 years and older.

Associated Conditions: Epilepsy, Primary Generalized Tonic-Clonic Seizures, Partial-Onset Seizures

Associated Therapies: -

Clinical Trials

A Study to Demonstrate Bioequivalence Between a 12-mg Dose of an Oral Suspension Formulation of Perampanel and a 12-mg Tablet Formulation of Perampanel Under Fasted and Fed Conditions in Healthy Subjects

Phase 1

Completed

Conditions: Healthy Subjects

Interventions: Drug: Perampanel

First Posted Date: 2014-10-31

Last Posted Date: 2015-11-03

Lead Sponsor: Eisai Inc.

Target Recruit Count: 100

Registration Number: NCT02279485

To Evaluate the Effect of Perampanel on Objective and Subjective Sleep in Subjects With Insomnia and Partial Onset Seizures

Phase 4

Withdrawn

Conditions: Epilepsy, Partial

Interventions: Drug: Perampanel
Drug: Placebo

First Posted Date: 2014-08-20

Last Posted Date: 2015-02-10

Lead Sponsor: Eisai Inc.

Registration Number: NCT02220972

Safety and Tolerability of Perampanel in Cervical Dystonia

Phase 1

Completed

Conditions: Cervical Dystonia

Interventions: Drug: Perampanel

First Posted Date: 2014-05-06

Last Posted Date: 2020-04-07

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 25

Registration Number: NCT02131467

Locations: 🇺🇸
Emory University School of Medicine, Atlanta, Georgia, United States
🇺🇸
Rush University Medical Center, Chicago, Illinois, United States
🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States

and more 2 locations

Rapid Determination Of The Clinical Utility Of Perampanel For The Treatment Of Alcohol Dependence

Phase 1

Completed

Conditions: Alcoholism

Interventions: Drug: Placebo
Drug: Perampanel

First Posted Date: 2014-04-22

Last Posted Date: 2023-08-18

Lead Sponsor: Virginia Commonwealth University

Target Recruit Count: 22

Registration Number: NCT02120365

Locations: 🇺🇸
Yale New Haven Hospital Research Unit, New Haven, Connecticut, United States
🇺🇸
University of Connecticut, Farmington, Connecticut, United States
🇺🇸
West Haven Veterans Affairs, West Haven, Connecticut, United States

and more 1 locations

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

Completed

Conditions: Epilepsy

Interventions: Drug: Perampanel

First Posted Date: 2014-01-13

Last Posted Date: 2018-09-07

Lead Sponsor: Eisai Inc.

Target Recruit Count: 500

Registration Number: NCT02033902

Locations: 🇬🇧
Eisai Site# 1606, Truro, United Kingdom
🇦🇹
Universitatsklinikum Innsbruck, Innsbruck, Austria
🇦🇹
Kepler Universitätsklinikum, Linz, Austria

and more 39 locations

A Multiple Dose Pharmacokinetic Study of Perampanel in Korean Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Perampanel

First Posted Date: 2013-12-25

Last Posted Date: 2015-03-03

Lead Sponsor: Eisai Co., Ltd.

Target Recruit Count: 20

Registration Number: NCT02020486

Locations: 🇰🇷
Inje University Busan Paik Hospital, Busan, Korea, Republic of

An Extended Access Program for Perampanel

Conditions: Partial Onset Seizures

First Posted Date: 2013-06-06

Last Posted Date: 2020-04-16

Lead Sponsor: Eisai Inc.

Registration Number: NCT01871233

Locations: 🇦🇺
St Vincent's Hospital Melbourne, Fitzroy, Australia
🇨🇿
Fakultni Nemocnice U Sv. Anny V Brne, Brno, Czechia
🇦🇺
Royal Melbourne Hospital, Parkville, Australia

and more 38 locations

Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor Fluctuations

Phase 2

Terminated

Conditions: Parkinson's Disease

Interventions: Drug: Perampanel

First Posted Date: 2012-07-06

Last Posted Date: 2014-07-09

Lead Sponsor: Eisai Inc.

Target Recruit Count: 185

Registration Number: NCT01634360

A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures

Phase 3

Completed

Conditions: Partial-onset Seizures

Interventions: Drug: Placebo
Drug: Perampanel

First Posted Date: 2012-06-13

Last Posted Date: 2021-07-29

Lead Sponsor: Eisai Co., Ltd.

Target Recruit Count: 940

Registration Number: NCT01618695

Locations: 🇹🇭
Facility #3, Tha Muang, Thailand
🇰🇷
Facility #6, Seoul, Korea, Republic of
🇹🇭
Facility #1, Tha Muang, Thailand

and more 8 locations

Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs

Phase 2

Completed

Conditions: Central Nervous System

Interventions: Drug: perampanel

First Posted Date: 2012-02-06

Last Posted Date: 2016-07-12

Lead Sponsor: Eisai Inc.

Target Recruit Count: 63

Registration Number: NCT01527006

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

© Copyright 2024. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy