drugset / Trial / NCT01618695
A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to confirm the efficacy and safety of perampanel compared to placebo in patients with refractory partial-onset seizures
Timeline
- Start
- 2012-05-15
- Primary completion
- 2014-09-15
- Completion
- 2020-05-28
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Perampanel 8 mg; p = 0.0003; Median Difference (Final Values) -16.45 (95% CI -25.683 to -7.251); ANCOVA NCT01618695 ↗
registry analysis (superiority test); Placebo vs Perampanel 12 mg; p <0.0001; Median Difference (Final Values) -24.95 (95% CI -33.878 to -16.235); ANCOVA NCT01618695 ↗
paper CONCLUSIONS: Adjunctive perampanel (8 and 12 mg/d) significantly improved seizure control in patients with refractory POS. PMID 29250772 ↗
Publications
- Bresnahan R, Hill RA, Wang J. Perampanel add-on for drug-resistant focal epilepsy. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD010961. doi: 10.1002/14651858.CD010961.pub2.
- Nishida T, Lee SK, Inoue Y, Saeki K, Ishikawa K, Kaneko S. Adjunctive perampanel in partial-onset seizures: Asia-Pacific, randomized phase III study. Acta Neurol Scand. 2018 Apr;137(4):392-399. doi: 10.1111/ane.12883. Epub 2017 Dec 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Perampanel | Small molecule | 4 mg | — |
| Subject | Perampanel | Small molecule | 8 mg | — |
| Subject | Perampanel | Small molecule | 12 mg | — |