A Efficacy and Safety Study of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures
Summary
This study is designed to evaluate the efficacy, safety, and pharmacokinetics (PK) of perampanel on Primary Generalized Tonic Clonic (PGTC) seizure frequency in adolescents and adults maintained on one to two stable antiepileptic drugs (AED).
Timeline
- Start
- 2011-09
- Primary completion
- 2014-05
- Completion
- 2015-11
Outcome
Met primary endpoint
registry Placebo (Core Study) vs Perampanel (Core Study); p = 0.0001; Median Difference (Final Values) -30.81 (95% CI -45.49 to -15.244); ANCOVA NCT01393743 ↗
registry Placebo (Core Study) vs Perampanel (Core Study); p = 0.0019; Cochran-Mantel-Haenszel NCT01393743 ↗
release “(Study 332) of its in-house-discovered AMPA receptor antagonist Fycompa® (generic name: perampanel) has met its primary endpoints in patients with primary generalized tonic-clonic (PGTC) seizures” eisai.com ↗
release “In Study 332, Fycompa demonstrated a statistically significant reduction in the primary endpoint of PGTC seizure frequency compared to placebo” eisai.com ↗
Publications
- Kerr WT, Brandt C, Ngo LY, Patten A, Cheng JY, Kramer L, French JA. Time to exceed pre-randomization monthly seizure count for perampanel in participants with primary generalized tonic-clonic seizures: A potential clinical end point. Epilepsia. 2022 Nov;63(11):2994-3004. doi: 10.1111/epi.17411. Epub 2022 Sep 30.
- French JA, Krauss GL, Wechsler RT, Wang XF, DiVentura B, Brandt C, Trinka E, O'Brien TJ, Laurenza A, Patten A, Bibbiani F. Perampanel for tonic-clonic seizures in idiopathic generalized epilepsy A randomized trial. Neurology. 2015 Sep 15;85(11):950-7. doi: 10.1212/WNL.0000000000001930.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Perampanel | Small molecule | 8 mg | — |