Highlights
- •PROVE was a retrospective, non-interventional phase IV study of perampanel.
- •This analysis evaluated final data from adolescent and adult patients.
- •Perampanel was associated with favorable retention rates and sustained efficacy.
- •No new safety signals were observed with perampanel in adolescent and adult patients.
Abstract
Purpose
Report final data from adolescent (12–<18 years) and adult (≥18 years) patients from
PROVE (NCT03208660), a multicenter, retrospective, non-interventional, Phase IV study
to assess retention, efficacy, safety, and dosing of perampanel in patients with epilepsy
during routine clinical care.
Methods
Data were retrospectively collected from medical/pharmacy records of patients in the
US initiating perampanel after January 1, 2014, according to treating clinicians’
recommendation. Retention rate was the primary efficacy endpoint. Secondary endpoints
included median percent changes in seizure frequency, seizure-freedom rates, investigator's
impression of seizure effect, and treatment-emergent adverse events (TEAEs).
Results
The Safety Analysis Set (SAS) included 294 adolescents and 1157 adults (median maximum
perampanel dose, 6.0 mg/day). In patients eligible for inclusion in the retention
rate analysis, 24-month retention rates were 53.5% (n=91/170) in adolescents and 47.8% (n=354/741) in adults. In patients with available efficacy data during Months 10–12,
median percent seizure frequency reductions were 79.3% (n=20) in adolescents and 70.8% (n=92) in adults. Most patients in the SAS with seizure-effect data experienced an improvement
in seizures at the last follow-up time point (adolescents, 51.4% [n=128/249]; adults, 52.3% [n=506/967]). TEAEs occurred in 113 adolescents (38.4%; most common, aggression [6.5%])
and 512 adults (44.3%; most common, dizziness [9.2%]).
Conclusion
Perampanel demonstrated favorable retention rates and sustained efficacy (up to 2
years) in adolescent and adult patients during routine clinical care; no new safety
signals were observed.
ClinicalTrials.gov identifier
NCT03208660 (https://clinicaltrials.gov/ct2/show/NCT03208660).
Keywords (max 6)
Abbreviations:
ASM (anti-seizure medication), FAS (Full Analysis Set), FOS (focal-onset seizures), GTC (generalized tonic-clonic), ILAE (International League Against Epilepsy), max (maximum), MedDRA (Medical Dictionary for Regulatory Activities), min (minimum), PROVE (Perampanel Real-world Evidence), SAS (Safety Analysis Set), SD (standard deviation), SMQ (standardized Medical Dictionary for Regulatory Activities query), TEAE (treatment-emergent adverse event)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: February 26, 2022
Accepted:
February 22,
2022
Received in revised form:
February 4,
2022
Received:
September 2,
2021
Identification
Copyright
© 2022 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.
