Completed Research Studies & Results

If you are thinking about taking part in a research study, including a clinical trial, there’s a lot to consider. Check out our FAQs, as well as our lists of Ongoing Research Studies and results from Past Research Studies below. Please contact us at if you know of any additional studies or results, or if the recruitment status for a study has changed, etc… You may also be interested in our SomnusNooze articles about Research Studies.

Note: If you are interested in trying a clinical trial treatment that is not available in your country, a company like WEP Clinical may be able to help you access this treatment.

DISCLAIMER: This listing is provided merely for informational purposes. Listing a study on this site/web page does not mean that it has been independently evaluated by the Hypersomnia Foundation. The safety and scientific validity of a study listed here is the responsibility of the study sponsor and investigators, not the Hypersomnia Foundation. Before making any decision as to whether or not to participate in a particular research study, you should (1) know the risks and potential benefits of that research study, and (2) consult your own healthcare provider.


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


A Study of the Efficacy and Safety of JZP-258 in the Treatment of IH

RECRUITING COMPLETED as of June 2020. Jazz Pharmaceuticals’ trial of JZP-258 (a low-sodium alternative for Xyrem): CLICK HERE.

Similar study of the Efficacy and Safety of JZP-258 in Subjects with Narcolepsy with Cataplexy: CLICK HERE (recruitment complete). In July 2020, Jazz Pharmaceuticals announced the U.S. FDA's approval of Xywav (JZP-258), as a treatment for cataplexy or excessive daytime sleepiness in narcolepsy patients.

In October, 2020, the U.S. FDA granted a Fast Track designation to Xywav for IH. Jazz Pharmaceuticals announced positive top-line results from the Phase 3 double-blind, multicenter, placebo-controlled, randomized withdrawal study evaluating the efficacy and safety of an investigational use of Xywav™ (calcium, magnesium, potassium, and sodium oxybates) oral solution in adult patients with idiopathic hypersomnia. “We are excited by these compelling results and the magnitude of improvement observed in the study, in particular for people living with idiopathic hypersomnia who currently have no approved treatment option. We are deeply grateful to the patients and investigators who participated in the study, and look forward to working quickly with the FDA to make Xywav available to patients as soon as possible," said Robert Iannone, MD, MSCE, executive vice president, research and development of Jazz Pharmaceuticals. Read more HERE.


Balance Therapeutics’ Study of Oral BTD-001 in Adults With IH (Arise2)

RECRUITING COMPLETED as of April 2020—adults age 18 to 70 with IH (including those currently on a stimulant regimen) across the USA (and Canada): ClinicalTrials.gov. BTD-001 is a GABA-antagonist that may possibly work similarly to flumazenil.

Preliminary Results: reported at the 2019 World Sleep Congress.

Results and information from the previous trial, Arise1:

In 2015, Balance Therapeutics announced the launch of the first double-blind, placebo-controlled, crossover, multicenter study of a drug (BTD-001) for the treatment of idiopathic hypersomnia (IH) and type 2 narcolepsy (T2N) in adults (Arise1): CLICK HERE for more information. Results as of December 2017: An open-label study of the efficacy, safety and tolerability of oral BTD-001 in adults with idiopathic hypersomnia or narcolepsy type 2.


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

RECRUITING COMPLETE as of December 2019: CLICK HERE. Phase 3 clinical trial of single-dose sodium oxybate by Avadel Pharmaceuticals (formerly Flamel, prior to 2017 merger). More info HERE.


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 Fall 2019, in Japan and S. Korea: CLICK HERE for the ClinicalTrials.gov listing. Taisho Pharmaceutical's TS-091 is a histamine H3 receptor inverse agonist (similar to pitolisant). As of October 2019, the study of TS-091 appears to have been discontinued for both hypersomnia and narcolepsy. Read more HERE.


The PATH Study: Psychosocial Adjunctive Treatment for Hypersomnia

RECRUITING COMPLETE as of August 2019: CLICK HERE for more information. The purpose of this study was to develop and test a new psychological treatment designed to improve psychosocial functioning in people with hypersomnia.

Results: 


Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients

RECRUITMENT COMPLETE as of Fall 2018: see clinicaltrials.gov. Theranexus' THN102 is a combination of modafinil and flecanide combo. Flecainide is "an antiarrhythmic agent used in this instance at very low dosages and for its modulating effects on the glial connexins.”

Results:

 


Umecrine Cognition’s Phase IIa Study of GR3027 in Patients with IH

RECRUITING COMPLETE as of Fall 2018. GR3027 was originally developed with the intention to reverse the hypersomnolence and impairments in cognition that occur in the clinical setting of liver failure – aka, hepatic encephalopathy. In October of 2017, Umecrine Cognition expanded their study of GR3027 to IH (see Umecrine Cognition Expands Study of New Medicine GR3027 to IH). 

In January, 2019, Umecrine Cognition announced their overall results from their Phase 2a Study. The primary study objectives were met in regard to safety and pharmacokinetics and also showed preliminary evidence of clinical efficacy. CLICK HERE to find out more about these results.

As of November, 2020, although GR3027 continues to be tested for liver failure, there has been no further development for IH.


Survey Study on Autonomic Impairment in Adults with Idiopathic Hypersomnia (IH)

RECRUITING COMPLETE as of September 2018. In 2018, HF promoted this Stanford University-based survey study of autonomic impairment in adults with IH. Autonomic dysfunction includes symptoms like dizziness, bowel or bladder trouble, and temperature and heart rate dysregulation.

Results:

  • May 2019 Autonomic Symptom Burden in Idiopathic Hypersomnia: abstract published as part of the annual meeting of the AAN (American Academy of Neurology). The researchers found that people with IH reported extremely high levels of autonomic dysfunction, on par with other conditions of severe autonomic failure, like MSA (multiple system atrophy) and diabetes. “Symptoms of ANS impairment, sleepiness, and fatigue are more severe in individuals with IH compared to controls. Moreover, ANS symptom burden correlates moderately with higher levels of sleepiness and fatigue.” The researchers also hope to complete follow-up studies and provide a more detailed exploration of the potential mechanisms involved. "Future analysis will focus on COMPASS [composite autonomic symptom score-31] subscores and objective autonomic testing to help identify symptomatic domains, with the goal of more focused therapeutic targets for patients with IH."
  • May 2020 Frequency and severity of autonomic symptoms in idiopathic hypersomnia: publication in the Journal of Clinical Sleep Medicine.

To read our original SomnusNooze article about this study, CLICK HERE.


BUNIHPPS—An Online Research Survey for Patients With Narcolepsy & IH

In 2015, a research team at Boston University developed BUNIHPPS—a survey research study for patients with narcolepsy and idiopathic hypersomnia. Also called the Boston University Narcolepsy and Idiopathic Hypersomnia Patient Perspectives Study, BUNIHPPS was an anonymous online survey forging into new frontiers by asking patients about their experiences with symptoms, the diagnostic process, and their attitudes and behaviors. Dr. William DeBassio, a pediatric neurologist, and Sara Kowalczyk, a doctoral student at Boston University, were the study investigators. For more information, CLICK HERE.

Results:


The TONES Study (Jazz Pharmaceuticals’ JZP-110/Solriamfetol)

In 2015, doctors began conducting the TONES medical research study of an investigational product (JZP-110) designed to treat sleepiness and to help adults stay awake. The researchers wanted to evaluate the product’s effectiveness against excessive sleepiness when taken once a day for 12 weeks. Participants had to have been diagnosed with narcolepsy and sleeping at least 6 hours a night. For further info, CLICK HERE.

Results of related research into JZP-110:


Health and Well-Being in Those With and Without a Disorder of Daytime Sleepiness—A Research Survey From Australia

In 2015, Victoria University in Melbourne, Australia, commenced a study about the general health and well-being of people within three groups. The first group was those people with both narcolepsy and cataplexy. (Cataplexy is a sudden loss of muscle tone, often triggered by emotional arousal.) The second group was people with either narcolepsy-without-cataplexy or idiopathic hypersomnia. The third group had no disorders of excessive daytime sleepiness. This project was part of a PhD program by Samantha Gauci (under the supervision of Prof. Dorothy Bruck and Dr. Warwick Hosking). One question in the study was whether the presence of cataplexy in narcolepsy was associated with a different level of general health and well-being (and some symptoms such as pain and migraines).

Results: