Additional Research Studies

A Web-Based Observational Study of Patient-Reported Outcomes in Adults with Narcolepsy

This is the Nexus Narcolepsy registry, a joint venture of Jazz Pharmaceuticals, Narcolepsy Network, and Wake Up Narcolepsy. See NOW RECRUITING people with narcolepsy INTERNATIONALLY: CLICK HERE to register.

Stanford University’s Kleine-Levin Syndrome Study

NOW RECRUITING people who have ever had KLS: CLICK HERE.

The Nuvigil and Provigil Pregnancy Registry

NOW RECRUITING pregnant women with narcolepsy, sleep apnea, and shift work disorder in the U.S.: CLICK HERE.

Once Nightly Formulation of Sodium Oxybate (FT218) for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy

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.

A Study to Evaluate Safety, and Efficacy of SUVN-G3031 in Patients with Narcolepsy with and Without Cataplexy

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.

Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in Narcolepsy

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.

Safety, Tolerability and Pharmacokinetics of ERX-963 in Adults With Myotonic Dystrophy Type 1

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.

Microglial Activation in Narcolepsy Type 1: Positron Emission Tomography (PET) Study

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.”

Exploration of the Reward System by Functional MRI in Narco-Cataplexy Patients with and Without REM Sleep Behavior Disorder

NOW RECRUITING adults age 18-80 in France: CLICK HERE.

Investigation of Clinical Feature and Brain Function in Narcoleptic Patients

NOW RECRUITING at Tangdu Hospital in Xi’an, Shaanxi Province, China: CLICK HERE.

Hospices Civils de Lyon

Study of the Academic and Professional Course of Narcoleptic Patients

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.”

XW Labs’ Phase 1 Study in Australia for Treatment of Narcolepsy with XW10172

See XW Labs Initiates First-in-Human Phase I Study for Novel Narcolepsy Treatment. More information at the Australian New Zealand Clinical Trials Registry.

Clock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson’s Disease

RECRUITMENT STATUS UNKNOWN, in S. Korea: CLICK HERE. Medicine available for off-label treatment in the U.S.

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Patients with Narcolepsy

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.

Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)

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).

A Study to Evaluate the Safety and Efficacy of TS-091 in Patients with Narcolepsy

RECRUITMENT COMPLETE, in Japan and S. Korea: CLICK HERE. The pharma company, Taisho, notes HERE that this drug is for central disorders of hypersomnolence.

Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients

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.

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