drugset / Trial / NCT03373383
Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of the study is to characterize the dose-response relationship with respect to efficacy of Padsevonil administered concomitantly with up to 3 anti-epileptic drugs (AEDs) for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.
Timeline
- Start
- 2018-02-12
- Primary completion
- 2020-01-30
- Completion
- 2020-01-30
Outcome
Missed primary endpoint
paper In both trials, the primary outcomes did not reach statistical significance in any PSL dose group compared with placebo. PMID 36176044 ↗
registry Placebo (FAS) vs Padsevonil 50mg BID (FAS); p =0.102; Percent reduction 17.2 (95% CI -3.8 to 33.9); ANCOVA NCT03373383 ↗
Publications
- Results Rademacher M, Toledo M, Van Paesschen W, Liow KK, Milanov IG, Esch ML, Wang N, MacPherson M, Byrnes WJ, Minh TDC, Webster E, Werhahn KJ. Efficacy and safety of adjunctive padsevonil in adults with drug-resistant focal epilepsy: Results from two double-blind, randomized, placebo-controlled trials. Epilepsia Open. 2022 Dec;7(4):758-770. doi: 10.1002/epi4.12656. Epub 2022 Oct 22.
- Results Kramer H, Bicer C, Otoul C, Rospo C, Macpherson M, Watling M, Bani M, Sciberras D, Chanteux H. Clinical Bridging Studies and Modeling Approach for Implementation of a Patient Centric Sampling Technique in Padsevonil Clinical Development. AAPS J. 2023 Nov 16;26(1):1. doi: 10.1208/s12248-023-00866-7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Padsevonil | Small molecule | 50 mg | — |
| Subject | Padsevonil | Small molecule | 100 mg | — |
| Subject | Padsevonil | Small molecule | 200 mg | — |
| Subject | Padsevonil | Small molecule | 400 mg | — |