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Brain Behav. 2016 Jun 28;6(9):e00505. eCollection 2016 Sep.

Review of clinical studies of perampanel in adolescent patients.

Author information

1
Division of Pediatric Neurology Yonsei University Severance Children's Hospital Seoul Korea.
2
Department of Pediatrics Tungs' Taichung Metro Harbor Hospital Taichung Taiwan.
3
Department of Paediatric Neurology King Chulalongkorn Memorial Hospital Bangkok Thailand.
4
Children's Department Danish Epilepsy Centre Filadelfia Dianalund Denmark.
5
Division of Neurology Department of Pediatrics Faculty of Medicine Ramathibodi Hospital Mahidol University Bangkok Thailand.
6
Department of Paediatrics Phramongkutklao Hospital Bangkok Thailand.
7
Department of Paediatrics KK Women's and Children's Hospital Singapore City Singapore.
8
Division of Paediatric Neurology Department of Paediatrics Faculty of Medicine University of Malaya Kuala Lumpur Malaysia.
9
Department of Pediatrics Taipei Veterans General Hospital Taipei Taiwan.
10
Department of Neurology Taipei Veterans General Hospital Taipei Taiwan.
11
Department of Pediatrics Mother Seton Hospital Camarines Sur Philippines.
12
Department of Pediatrics College of Medicine Taipei Medical University Taipei Taiwan.
13
Department of Pediatrics Faculty of Medicine Siriraj Hospital Mahidol University Bangkok Thailand.
14
Department of Pediatrics National Taiwan University Hospital Taipei Taiwan.
15
Department of Pediatrics The Duchess of Kent Children's Hospital Sandy Bay Hong Kong.
16
Eisai Pharmaceuticals India Pvt., Ltd. Mumbai India.

Abstract

AIM:

To assess the clinical trial and real-world data for adjunctive perampanel in adolescents and develop consensus recommendations to guide the use of perampanel in this population in clinical practice.

METHODS:

In May 2015, 15 epilepsy experts attended a Consensus Development Meeting to assess the clinical trial data for perampanel, specific to the adolescent age group (12-17 years) and develop consensus treatment recommendations.

RESULTS AND DISCUSSION:

Analysis of the adolescent subgroup data of three pivotal placebo-controlled, double-blind, phase 3 trials investigating perampanel in patients with ongoing focal epileptic seizures despite receiving one to three antiepileptic drugs found that perampanel 4-12 mg was superior to placebo. The tolerability profile of perampanel was generally acceptable. Adolescent patients receiving long-term treatment with perampanel in an open-label extension study maintained improvements in seizure control compared with baseline, with a favorable risk-benefit profile. A phase 2 study showed that perampanel had no clinically important effects on cognitive function, growth, and development.

CONCLUSION:

Perampanel is a welcome addition to the armamentarium of existing antiepileptic drugs as it represents a new approach in the management of epilepsy, with a novel mechanism of action, and the potential to have a considerable impact on the treatment of adolescents with epilepsy.

KEYWORDS:

Adolescent; Anticonvulsants; consensus; epilepsy; perampanel; receptors AMPA

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