Sodium Oxybate in Idiopathic Hypersomnia

Phase 2/3 Completed 48 enrolled University Hospital, Montpellier

RandomizedParallel-groupTriple-blindTreatment

Summary

this study evaluates of the efficacy of sodium oxybate on excessive daytime sleepiness using Epworth sleepiness scale over 8 weeks compared to placebo

Timeline

Start: 2018-10-18
Primary completion: 2023-04-12
Completion: 2023-04-12

Outcome

Met primary endpoint

paper In the intention-to-treat analysis, the mean ESS score was significantly reduced in the SXB group compared with placebo, after adjusting for the baseline score PMID 40359459 ↗

paper least squared [LS] mean difference: -6.86, 95% CI [-9.73 to -4.00]), p < 0.0001). PMID 40359459 ↗

Publications

Dauvilliers Y, Chenini S, Thobois O, Rassu AL, Denis C, Guiraud L, Jaussent I, Barateau L. Efficacy and Safety of Sodium Oxybate in Adults With Idiopathic Hypersomnia: A Randomized Controlled Trial. Neurology. 2025 Jun 10;104(11):e213690. doi: 10.1212/WNL.0000000000213690. Epub 2025 May 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sodium Oxybate	Unknown	6 g	Oral
Subject	Sodium Oxybate	Unknown	9 g	Oral