PROVE-Phase IV Study of Perampanel in Real-World Clinical Care of Patients with Epilepsy: Interim Analysis in Pediatric Patients
Eric Segal1,2,3, Katherine Moretz1, James Wheless4
13673Hackensack University Medical Center, 576909Hackensack Meridian School of Medicine, Hackensack, NJ, USA.
Insights
Perampanel is generally well-tolerated in pediatric epilepsy patients, showing good retention rates up to two years. Common side effects include aggression and somnolence in both age groups.
Area of Science:
- Neurology
- Pediatric Epilepsy
- Pharmacovigilance
Background:
- Epilepsy affects children and adolescents, requiring effective and safe treatment options.
- Perampanel is an antiepileptic drug used for seizure management.
- Real-world data on perampanel use in pediatric populations is limited.
Purpose of the Study:
- To assess the retention, dosing, efficacy, and safety of perampanel in preadolescent and adolescent patients with epilepsy.
- To provide an interim analysis of the PROVE study data for pediatric populations.
Main Methods:
- Retrospective, phase IV study design.
- Analysis of medical records from patients aged 1 to <18 years initiating perampanel.
- Inclusion of 151 preadolescent and 183 adolescent patients.
Main Results:
- 24-month retention rates were 42.5% for preadolescents and 55.7% for adolescents.
- Treatment-emergent adverse events reported in 35.1% of preadolescents and 42.6% of adolescents.
- Most common adverse events included aggression, irritability, and somnolence.
Conclusions:
- Perampanel demonstrates generally favorable retention rates and tolerability in pediatric epilepsy patients up to two years.
- Daily oral perampanel can be safely administered in routine clinical care for patients aged 1 to <18 years.
- Further long-term data will continue to inform perampanel's role in pediatric epilepsy management.
Abstract:
PROVE is a retrospective, phase IV study assessing retention, dosing, efficacy, and safety of perampanel when administered to patients during routine clinical care. We report an interim analysis of preadolescent (1 to <12 years) and adolescent (12 to <18 years) patients. Data were obtained from medical records of patients with epilepsy initiating perampanel after January 1, 2014; cut-off date for this analysis was October 10, 2018. Overall, 151 preadolescent and 183 adolescent patients were included. Retention rates following 24 months on perampanel were 42.5% (preadolescent subgroup; n = 31/73) and 55.7% (adolescent subgroup; n = 54/97). Treatment-emergent adverse events occurred in 53 (35.1%) preadolescent (most common: aggression, irritability, and somnolence) and 78 (42.6%) adolescent patients (most common: somnolence, aggression, and dizziness). These data indicate that daily oral doses of perampanel are generally well tolerated during routine clinical care, with favorable retention rates for ≤2 years, in patients aged 1 to <18 years.
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