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 ClinicalTrials.gov. NOW RECRUITING people with narcolepsy INTERNATIONALLY: CLICK HERE to register.
Takeda’s Sparkle Studies: Evaluating Novel Orexin 2 Receptor Agonists for IH and Narcolepsy
The SPARKLE studies are testing investigational orexin 2 receptor agonists (intravenous TAK-925 and oral TAK-994) to see if they could potentially be a safe and effective way to help increase wakefulness for people with idiopathic hypersomnia or narcolepsy. For more information on Takeda’s orexin development program and upcoming clinical studies with TAK-925 and TAK-994, please visit their SPARKLE program.
SPARKLE 1501: NOW RECRUITING in the U.S., adults age 18-65 with narcolepsy (with or without cataplexy): CLICK HERE to see if you qualify (further info from ClinicalTrials.gov). This is a phase 1 study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising oral doses of TAK-994 in people with narcolepsy.
SPARKLE 2002: RECRUITING/ENROLLMENT COMPLETED as of November 2020 (further info from ClinicalTrials.gov). SPARKLE 2002 study was designed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of an intravenous (IV) dose of TAK-925 in adults who have been diagnosed with idiopathic hypersomnia (IH).
These are follow-ups to Takeda’s earlier studies: 1) “Phase 1 TAK-925 Study in Healthy Adult and Elderly Volunteers and Patients with Narcolepsy” (further info from ClinicalTrials.gov); 2) “A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Patients with Narcolepsy” (further info from ClinicalTrials.gov).
See also Takeda’s September 2019 Press Release: New Data Presented at World Sleep Congress Demonstrate Early Signs of Efficacy for TAK-925, a Selective Orexin Type-2 Receptor (OX2R) Agonist, in Patients with Narcolepsy Type 1
Awareness and Self-Compassion Enhancing Narcolepsy Treatment (ASCENT)
NOW RECRUITING adults with narcolepsy in the U.S. The Behavioral Sleep Medicine Lab at Northwestern is evaluating the feasibility of a mindfulness meditation program designed to reduce psychological distress for people with narcolepsy. The principal investigator is Jason Ong, PhD, a member of HF’s medical advisory board.
Eligible volunteers will be asked to:
- Complete an assessment to determine eligibility to participate.
- Participate in a mindfulness intervention delivered through live video conferencing.
- Complete study assessments every four weeks for 12 weeks.
If interested, please email or call (312) 503-6627. For more information from clincialtrials.gov, CLICK HERE.
This is a follow-up to the PATH study.
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.
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.
A Study of TAK-994 in Participants With Narcolepsy Type 1
NOT YET RECRUITING adults ages 18-65 with a diagnosis of narcolepsy type 1 in N. America and Japan: CLICK HERE. The purpose of this study is to assess the safety and tolerability of TAK-994 (an oral selective orexin-receptor agonist) following multiple doses in participants with NT1. The overall duration of the study is 35 days and participants will be followed up to 7 days after the last dose of study drug.
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.
International Clinical Trial Registries
- Australian New Zealand Clinical Trials Registry (ANZCTR)
- Brazilian Clinical Trials Registry (ReBEC)
- Chinese Clinical Trial Registry (ChiCTR)
- Clinical Research Information Service, Republic of Korea (CRiS)
- Clinical Trials Registry—India (CTRI)
- Cuban Public Registry of Clinical Trials (RPCEC)
- EU Clinical Trials Register (EU-CTR)
- German Clinical Trials Register (DRKS)
- Iranian Registry of Clinical Trials (IRCT)
- Pan African Clinical Trial Registry (PACTR)
- Sri Lanka Clinical Trials Registry (SLCTR)
- UK ISRCTN registry
- UMIN Clinical Trials Registry, Japan (UMIN-CTR)
- USA (ClinicalTrials.gov)