A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension

Summary

This is a study of the efficacy and safety of JZP-258, an oxybate mixed-salts oral solution being developed as a low sodium alternative product for Xyrem.

Timeline

Start

2018-11-27

Primary completion

2020-06-12

Completion

2020-12-18

Publications

• Lin J, Lowe C, Banderas B, Chandler P, Arenson E, Shields AL, Morris S, Srivastava B, Dauvilliers Y. Content Validity and Psychometric Evaluation of the Idiopathic Hypersomnia Severity Scale (IHSS) in Adults with Idiopathic Hypersomnia. Nat Sci Sleep. 2026 Jun 26;18:571289. doi: 10.2147/NSS.S571289. eCollection 2026.
• Bogan RK, Fuller DS, Whalen M, Casstevens C, Schneider LD. A minimal clinically important difference for the sleep inertia visual analog scale in idiopathic hypersomnia. J Clin Sleep Med. 2025 Jul 1;21(7):1209-1216. doi: 10.5664/jcsm.11662.
• Morse AM, Dauvilliers Y, Arnulf I, Thorpy MJ, Foldvary-Schaefer N, Chandler P, Chen A, Hickey L, Black J, Bogan RK. Long-term efficacy and safety of low-sodium oxybate in an open-label extension period of a placebo-controlled, double-blind, randomized withdrawal study in adults with idiopathic hypersomnia. J Clin Sleep Med. 2023 Oct 1;19(10):1811-1822. doi: 10.5664/jcsm.10698.
• Dauvilliers Y, Arnulf I, Foldvary-Schaefer N, Morse AM, Sonka K, Thorpy MJ, Mignot E, Chandler P, Parvataneni R, Black J, Sterkel A, Chen D, Skobieranda F, Bogan RK. Safety and efficacy of lower-sodium oxybate in adults with idiopathic hypersomnia: a phase 3, placebo-controlled, double-blind, randomised withdrawal study. Lancet Neurol. 2022 Jan;21(1):53-65. doi: 10.1016/S1474-4422(21)00368-9.

Drugs

Indications