A Study to Test the Efficacy and Safety of Padsevonil as Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy

Summary

The purpose of the study is to evaluate the efficacy, safety and tolerability of the 3 selected dose regimens of padsevonil (PSL) administered concomitantly with up to 3 anti-epileptic drugs (AEDs) compared with placebo for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.

Timeline

Start

2019-03-06

Primary completion

2020-09-28

Completion

2020-09-28

Outcome

Missed primary endpoint

Stopped: “Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizure”

paper In both trials, the primary outcomes did not reach statistical significance in any PSL dose group compared with placebo. PMID 36176044 ↗

registry analysis (superiority test); Placebo (FAS) vs Padsevonil 100 mg BID (FAS); p =0.687 NCT03739840 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Padsevonil	Small molecule	100 mg	—
Subject	Padsevonil	Small molecule	200 mg	—
Subject	Padsevonil	Small molecule	400 mg	—

Indications