This is the Nexus Narcolepsy registry, a joint venture of Jazz Pharmaceuticals, Narcolepsy Network, and Wake Up Narcolepsy. See ClinicalTrials.gov. NOW RECRUITING people with narcolepsy INTERNATIONALLY: CLICK HERE to register.
NOW RECRUITING people age 16 and up with narcolepsy in Australia, Canada, Europe, and the U.S.: CLICK HERE. Phase 3 clinical trial of single-dose sodium oxybate by Avadel Pharmaceuticals (formerly Flamel, prior to 2017 merger). More info HERE.
NOW RECRUITING people with narcolepsy in the U.S.: CLICK HERE. This is a Phase 2 clinical trial of SUVN-G3031, which is a histamine H3 receptor inverse agonist (similar to pitolisant). Preclinical information can be found HERE.
NOW RECRUITING in the U.S.: CLICK HERE. Jazz Pharmaceuticals also has a study arm for OSA (obstructive sleep apnea), which is also RECRUITING – CLICK HERE. And a separate 4-week study of safety, efficacy, and pharmacokinetics of JZP-110 in Parkinson’s disease with excessive daytime sleepiness, which is also currently RECRUITING – CLICK HERE. There are also several separate studies of JZP-110, which are ongoing but no longer recruiting: 1) 12-week safety and efficacy in OSA – CLICK HERE; 2) 12-week safety and efficacy in narcolepsy – CLICK HERE; 3) long-term safety in narcolepsy and OSA – CLICK HERE; and 4) 6-week study of safety and efficacy in OSA – CLICK HERE. See Past Research Studies tab for current results. Also, for Jazz Pharmaceuticals’ trial of the Safety and Effectiveness of ADX-N05 (another name for JZP-110) for Excessive Daytime Sleepiness in Subjects With Narcolepsy, which is completed: CLICK HERE.
NOW RECRUITING adults age 18-60 with myotonic dystrophy type 1 (DM1), in the U.S: CLICK HERE. DM1 is often associated with hypersomnia. The study purpose is to evaluate the safety and tolerability of ERX-963 and its potential use as a treatment to reduce excessive daytime sleepiness / hypersomnia and improve cognitive function in DM1 participants compared to placebo treatment.
NOW RECRUITING people age 10 and older with narcolepsy type 1, in France: CLICK HERE. The goal is “to study the cerebral microglial activation in PET in NT1 patients with recent evolution (appearance of the first symptoms – somnolence and cataplexy – less than 2 years ago) in comparison with controls; then analyze the effect of age, and the severity of symptoms on this PET imaging biomarker.”
NOW RECRUITING adults age 18-80 in France: CLICK HERE.
NOW RECRUITING at Tangdu Hospital in Xi’an, Shaanxi Province, China: CLICK HERE.
NOT YET RECRUITING children and adults with narcolepsy type 1, in France: CLICK HERE. This study proposes “to establish a comprehensive inventory of educational and professional trajectories of narcoleptic patients in France in order assess the specificity of the difficulties encountered by the people concerned in their life course and to appreciate the attitude of the academic and professional circle with respect to the disease.”
See XW Labs Initiates First-in-Human Phase I Study for Novel Narcolepsy Treatment. More information at the Australian New Zealand Clinical Trials Registry.
RECRUITMENT COMPLETE, in Japan: CLICK HERE. This is a follow-up to Takeda’s earlier study: “Phase 1 TAK-925 Study in Healthy Adult and Elderly Volunteers and Patients with Narcolepsy” (CLICK HERE to read more). TAK-925 is an orexin 2 receptor agonist.
RECRUITING COMPLETE: CLICK HERE. Axsome Therapeutics is enrolling people with narcolepsy with cataplexy (only) for a study of the efficacy of AXS-12 (reboxetine) for treatment of cataplexy and excessive daytime sleepiness. AXS-12 is an oral norepinephrine reuptake inhibitor (NRI).
Theranexus THN102 (modafinil/flecanide combo). RECRUITMENT COMPLETE, in France: CLICK HERE. For more info: 1) First Clinical Study Completed on Effectiveness of Possible Narcolepsy Drug THN102. Flecainide is “an antiarrhythmic agent used in this instance at very low dosages and for its modulating effects on the glial connexins”; and 2) Hungary OKs Phase 2 Clinical Trial of Drug Candidate for Excessive Daytime Sleepiness in Parkinson’s.