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Review of clinical studies of perampanel in adolescent patients
- Source :
- Brain and Behavior
- Publication Year :
- 2016
- Publisher :
- Wiley, 2016.
-
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.
- Subjects :
- 0301 basic medicine
Pediatrics
medicine.medical_specialty
Adolescent
Population
Reviews
Phases of clinical research
Review
Placebo
Adolescent age
receptors AMPA
03 medical and health sciences
Behavioral Neuroscience
Perampanel
chemistry.chemical_compound
Epilepsy
0302 clinical medicine
perampanel
medicine
education
Psychiatry
education.field_of_study
business.industry
medicine.disease
Clinical trial
030104 developmental biology
Tolerability
chemistry
consensus
epilepsy
Anticonvulsants
business
030217 neurology & neurosurgery
Subjects
Details
- ISSN :
- 21623279
- Volume :
- 6
- Database :
- OpenAIRE
- Journal :
- Brain and Behavior
- Accession number :
- edsair.doi.dedup.....7f8342e8b4d5f7c61c721e54a85babbc
- Full Text :
- https://doi.org/10.1002/brb3.505