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

Post-market Study of AMPA Receptor Antagonists for Epilepsy Patients in Hong Kong

Conditions: Generalized Epilepsy
Partial Seizures, Simple
Focal Epilepsy

Interventions: Drug: Perampanel

First Posted Date: 2018-03-08

Last Posted Date: 2020-08-27

Lead Sponsor: Chinese University of Hong Kong

Target Recruit Count: 80

Registration Number: NCT03457961

Locations: 🇭🇰
Prince of Wales Hospital, Hong Kong, Hong Kong

Pharmacokinetic Study of Perampanel in Chinese Healthy Subjects

Phase 1

Completed

Conditions: Healthy Subjects

Interventions: Drug: Perampanel

First Posted Date: 2018-02-07

Last Posted Date: 2018-08-28

Lead Sponsor: Eisai Co., Ltd.

Target Recruit Count: 44

Registration Number: NCT03424564

Locations: 🇨🇳
Eisai Trial Site, Beijing, Beijing, China

Bioequivalence Study Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects

Phase 1

Completed

Conditions: Healthy Participants

Interventions: Drug: Perampanel

First Posted Date: 2018-01-16

Last Posted Date: 2018-10-29

Lead Sponsor: Eisai Co., Ltd.

Target Recruit Count: 24

Registration Number: NCT03399734

Locations: 🇯🇵
Eisai Trial Site, Toshima-ku, Tokyo, Japan

Study to Evaluate Bioavailability of a Single 12 mg Dose of Perampanel for Three Intravenous Infusion Durations Relative to a Single 12 mg Perampanel Oral Tablet in Healthy Subjects

Phase 1

Completed

Conditions: Healthy Participants

Interventions: Drug: Perampanel

First Posted Date: 2017-12-19

Last Posted Date: 2018-09-07

Lead Sponsor: Eisai Inc.

Target Recruit Count: 48

Registration Number: NCT03376997

Locations: 🇺🇸
Anaheim Clinical Trials, Anaheim, California, United States

Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response

Phase 1

Completed

Conditions: Bipolar Disorder
Depressive Disorder, Major
Post Traumatic Stress Disorder

Interventions: Drug: Ketamine
Drug: Placebo
Drug: Perampanel

First Posted Date: 2017-12-08

Last Posted Date: 2024-05-08

Lead Sponsor: Yale University

Target Recruit Count: 13

Registration Number: NCT03367533

Locations: 🇺🇸
Yale University, New Haven, Connecticut, United States

Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures

Phase 4

Completed

Conditions: Primary Generalized Tonic-Clonic Seizures
Partial Onset Seizures
Secondarily Generalized Seizures

Interventions: Drug: Perampanel

First Posted Date: 2017-09-19

Last Posted Date: 2022-05-16

Lead Sponsor: Eisai Inc.

Target Recruit Count: 54

Registration Number: NCT03288129

Locations: 🇺🇸
Mount Sinai Medical Center, New York, New York, United States
🇺🇸
UCSD Epilepsy Center, La Jolla, California, United States
🇺🇸
Michigan State University, East Lansing, Michigan, United States

and more 21 locations

Population Pharmacokinetics of Antiepileptic in Pediatrics

First Posted Date: 2017-06-22

Last Posted Date: 2024-10-30

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 1000

Registration Number: NCT03196466

Locations: 🇫🇷
AP-HP Cochin, Paris, France

A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Not Applicable

Terminated

Conditions: Amyotrophic Lateral Sclerosis

Interventions: Drug: Placebo Oral Tablet
Drug: Perampanel

First Posted Date: 2017-01-13

Last Posted Date: 2023-05-06

Lead Sponsor: Stony Brook University

Target Recruit Count: 12

Registration Number: NCT03020797

Locations: 🇺🇸
Stony Brook University Medical Center, Stony Brook, New York, United States

Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS)

Phase 2

Completed

Conditions: ALS

Interventions: Drug: placebo
Drug: Perampanel

First Posted Date: 2017-01-12

Last Posted Date: 2021-01-15

Lead Sponsor: Tokyo Medical University

Target Recruit Count: 66

Registration Number: NCT03019419

Locations: 🇯🇵
Shiga University of Medical Science Hospital, Shiga, Japan
🇯🇵
Tokyo Medical University, Tokyo, Japan
🇯🇵
Kitasato University East Hospital, Kanagawa, Japan

and more 9 locations

Pharmacokinetic Study With an Oral Suspension of Perampanel as Adjunctive Therapy in Pediatric Subjects With Epilepsy

Phase 2

Completed

Conditions: Epilepsy

Interventions: Drug: perampanel

First Posted Date: 2016-09-26

Last Posted Date: 2024-03-15

Lead Sponsor: Eisai Inc.

Target Recruit Count: 26

Registration Number: NCT02914314

Locations: 🇺🇸
Axcess Medical Research, Loxahatchee Groves, Florida, United States
🇺🇸
Pediatric Epilepsy And Neurology Specialists, Tampa, Florida, United States
🇺🇸
NW FL Clinical Research Group, LL-ClinEdge- PPDS, Gulf Breeze, Florida, United States

and more 15 locations

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