Perampanel

Generic Name
Perampanel
Brand Names
Fycompa
Drug Type
Small Molecule
Chemical Formula
C23H15N3O
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
-

Demonstrate Bioequivalence Between 6 ? 2-mg Tablets of Perampanel and a Single 12-mg Tablet of Perampanel in Healthy Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-07-19
Last Posted Date
2012-05-04
Lead Sponsor
Eisai Inc.
Target Recruit Count
54
Registration Number
NCT01396590

Demonstrate Bioequivalence Between 3 x 2-mg Tablets of Perampanel and a Single 6-mg Tablet of Perampanel in Healthy Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-07-19
Last Posted Date
2012-05-04
Lead Sponsor
Eisai Inc.
Target Recruit Count
54
Registration Number
NCT01396577

A Efficacy and Safety Study of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures

First Posted Date
2011-07-13
Last Posted Date
2017-08-28
Lead Sponsor
Eisai Inc.
Target Recruit Count
163
Registration Number
NCT01393743

A Study to Demonstrate Bioequivalence Between 6 x 2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-11-15
Last Posted Date
2013-05-14
Lead Sponsor
Eisai Inc.
Target Recruit Count
22
Registration Number
NCT01240187
Locations
🇬🇧

Quotient Clinical, Edinburgh, United Kingdom

A Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics in Adolescents

Phase 2
Completed
Conditions
Interventions
First Posted Date
2010-07-13
Last Posted Date
2019-05-15
Lead Sponsor
Eisai Inc.
Target Recruit Count
133
Registration Number
NCT01161524

A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-05-18
Last Posted Date
2018-08-29
Lead Sponsor
Eisai Co., Ltd.
Target Recruit Count
21
Registration Number
NCT00903786

Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-08-14
Last Posted Date
2016-03-14
Lead Sponsor
Eisai Inc.
Target Recruit Count
1218
Registration Number
NCT00735397

Evaluating Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-06-18
Last Posted Date
2016-01-21
Lead Sponsor
Eisai Inc.
Target Recruit Count
712
Registration Number
NCT00700310
Locations
🇦🇺

The Queen Elizabeth Hospital, Woodville, South Australia, Australia

🇷🇺

Moscow State University of Medicine and Dentistry, Moscow, Russian Federation

🇭🇰

Queen Mary Hospital, Hong Kong, Hong Kong

and more 10 locations

Assessment of Perampanel (E2007) on Synaptic Dopamine in Mild-moderate PD Patients: A Pilot Study With [^123I]-IBZM SPECT

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2007-12-03
Last Posted Date
2018-09-06
Lead Sponsor
Eisai Inc.
Target Recruit Count
1
Registration Number
NCT00566462
Locations
🇺🇸

inVentiv, The Woodlands, Texas, United States

🇺🇸

Kenneth Marek, New Haven, Connecticut, United States

🇺🇸

Molecular NeuroImaging, LLC, New Haven, Connecticut, United States

Evaluation of the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2007-07-23
Last Posted Date
2016-01-21
Lead Sponsor
Eisai Limited
Target Recruit Count
328
Registration Number
NCT00505622
Locations
🇫🇷

Centre d'Investigation Clinique, Hospital Purpan, Toulouse, Toulouse Cedex, France

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