Efficacy and Safety Trial With S 44819 After Recent Ischemic Cerebral Event

Summary

The purpose of this study is to assess the efficacy and safety of S 44819 in enhancing functional recovery after an ischemic stroke.

Timeline

Start

2016-12-19

Primary completion

2019-03-10

Completion

2019-03-10

Outcome

Missed primary endpoint

paper The primary endpoint of mRS at day 90 did not differ between each of the two S44819 groups and the placebo group PMID 32085836 ↗

Publications

• Background Chabriat H, Bassetti CL, Marx U, Picarel-Blanchot F, Sors A, Gruget C, Saba B, Wattez M, Audoli ML, Hermann DM. Randomized Efficacy and Safety Trial with Oral S 44819 after Recent ischemic cerebral Event (RESTORE BRAIN study): a placebo controlled phase II study. Trials. 2020 Feb 3;21(1):136. doi: 10.1186/s13063-020-4072-2.
• Results Chabriat H, Bassetti CL, Marx U, Audoli-Inthavong ML, Sors A, Lambert E, Wattez M, Hermann DM; RESTORE BRAIN study investigators. Safety and efficacy of GABAA alpha5 antagonist S44819 in patients with ischaemic stroke: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2020 Mar;19(3):226-233. doi: 10.1016/S1474-4422(20)30004-1.

Drugs

Indications

No indication recorded.