Post-Marketing Observational Study to Evaluate Safety and Tolerability of Perampanel as Add-On Therapy in Patients with Epilepsy: Post Hoc Analysis by Dose and Enzyme-Inducing Anti-Seizure Drugs
Abstract number :
3.313
Submission category :
7. Antiepileptic Drugs / 7B. Clinical Trials
Year :
2019
Submission ID :
2422207
Source :
www.aesnet.org
Presentation date :
12/9/2019 1:55:12 PM
Published date :
Nov 25, 2019, 12:14 PM
Authors :
#N/A; Anna Patten, Eisai Ltd., Hatfield, Hertfordshire, UK; Leock Y. Ngo, Eisai Inc., Woodcliff Lake, NJ, USA
Rationale: Post-marketing safety studies provide additional information on the safety and tolerability of an approved drug in a real world setting. Perampanel is a once-daily oral anti-seizure drug (ASD) for focal (previously partial-onset) seizures and generalized tonic-clonic seizures (previously primary generalized tonic-clonic seizures). Study 402 (NCT02033902) collected information about clinically important treatment-emergent adverse events (TEAEs) when perampanel was prescribed as add-on therapy in clinical practice to patients (pts) with refractory epilepsy aged >=12 years. This post hoc analysis reports safety data from Study 402 by perampanel dose at onset of the TEAE, and the presence or absence of an enzyme-inducing ASD (EIASD). Methods: Study 402 was a post-marketing, observational study conducted in pts with refractory epilepsy aged >=12 years from Austria, Belgium, Czech Republic, Denmark, France, Israel, Sweden, and the UK. The study consisted of a Screening Visit, 52-week Treatment Period, and End-of-Study Visit. Pts discontinuing before Week 52 had an Early Termination Visit/Follow-up Visit 2 weeks later. Perampanel was initiated at 2 mg/day and titrated to <=12 mg/day based on efficacy and tolerability. Safety data were gathered prospectively at clinic visits, and incidence of TEAEs assessed by perampanel dose at onset (<=2, >
Antiepileptic Drugs