Jazz Pharmaceuticals has enrolled the first patient in a Phase III clinical trial to assess the efficacy and safety of JZP-258 for the treatment of idiopathic hypersomnia.
The double-blind, placebo-controlled, randomised-withdrawal trial aims to enrol around 140 adult patients.
It features an open-label safety extension phase and will be carried out in various study centres in the US and EU.
Primary objective of the trial is change in Epworth Sleepiness Scale (ESS) score.
Secondary endpoints comprise the Patient Global Impression of Change (PGIc), Clinical Global Impression of Change (CGIc), and change in total score on Hypersomnolence Severity Scale (HSS).
Jazz Pharmaceuticals sleep and CNS medicine senior vice-president Jed Black said: “Idiopathic hypersomnia is a debilitating orphan disease and an area of significant unmet patient need since there are no therapies approved to treat it and general awareness of idiopathic hypersomnia is low.
“This clinical trial is an example of Jazz’s commitment to collaborating with the sleep community to advance sleep science and develop potential new treatment options for people with chronic, disabling sleep disorders.”
Idiopathic hypersomnia is characterised by chronic and disabling excessive daytime sleepiness that is not caused by the available conditions known to drive excessive daytime sleepiness.
Jazz Pharmaceuticals is currently investigating JZP-258 as a potential treatment of cataplexy and excessive daytime sleepiness in narcolepsy as well as idiopathic hypersomnia.
JZP-258 comprises an oxybate mixed-salts oral solution with 90% less sodium than xyrem (sodium oxybate) oral solution.