Completed research studies and results

A paid opportunity to share your experiences of living with idiopathic hypersomnia in a one-time, individual interview

WHO IS ELIGIBLE?

• Adults aged 18 years and older and residing in the United States.
• Diagnosed with idiopathic hypersomnia by a physician. (Proof of diagnosis is required.)

PARTICIPATION DETAILS

• If you are eligible, you will be invited to participate in an individual, web-based interview about how idiopathic hypersomnia affects you. The interview will last no more than 90 minutes.
• Participants will also be asked to complete a brief demographic and health background form before the interview (approximately 5 minutes).
• As a thank you for your participation, you will receive $125.00.

If you are interested in participating or have any questions about the study, please call Jane Beck with The Brod Group at (415) 317-3987 or email jane@thebrodgroup.net.

Pinpoint Patient Recruiting, a market research recruitment company, is searching for people who have been diagnosed with idiopathic hypersomnia (IH) to participate in a 45-minute online survey about their experience. Those who qualify and participate in the study will receive $75 as a thank you. All information and responses will remain confidential.

Interested?
To see if you qualify for the study or to get more information, please visit pinpointpatientrecruiting.com/ih-survey or contact Julie Knell at julie@pinpointpatientrecruiting.com.

This is a double-blind, placebo-controlled, randomized withdrawal, multicenter study of the efficacy and safety of FT218. FT218 drug product is a once-nightly formulation of sodium oxybate for extended-release oral suspension. The study will enroll subjects who are diagnosed with idiopathic hypersomnia. Subjects will be eligible to enroll regardless of current treatment with oxybate therapy or stimulants/alerting agents at study entry. The estimated total duration of study for each subject is approximately 18 weeks, including the Screening period.

RECRUITMENT COMPLETE as of August 2023 for adults (18 and over) with Narcolepsy Type 1: CLICK HERE.

If you have narcolepsy with cataplexy (also known as narcolepsy type 1), you may be eligible to participate in research. The purpose of the RaiseUp Study is to evaluate the safety and effectiveness of an investigational study drug in the treatment of adults who have narcolepsy type 1 (NT1). This study may help researchers understand how the body processes the investigational study drug and how it may affect excessive daytime sleepiness (EDS).

Who Can Participate?

Eligible participants must:

• Be 18 to 70 years of age.
• Have received an NT1 diagnosis within the past 10 years or are experiencing NT1 symptoms (characterized by cataplexy, or the sudden loss of muscle control and muscle weakness due to strong emotions or actions, like anger or laughter, while remaining conscious).
• Be willing to stop any current NT1 treatment.

For more information about the RaiseUp Study or to take the prescreening questionnaire and see if you may qualify, talk to your doctor and visit the RaiseUp Study website.

RECRUITMENT COMPLETE as of June 2023 for people with narcolepsy (type 1 and 2) age 18-50 in the U.S.: CLICK HERE for research sites across the U.S. This is a Phase 2 clinical trial of SUVN-G3031, which is an investigational medicine (a histamine H3 receptor inverse agonist, similar to pitolisant, which is a tablet taken once daily). Preclinical information can be found HERE. For further information from clinicaltrials.gov, CLICK HERE.

This research study is testing the effectiveness of SUVN-G3031 to reduce the symptoms of narcolepsy. Qualified participants will be seen by a doctor and receive all study-related exams, care and medications at no cost. Those who qualify will be asked to participate for approximately 7 weeks, which will include at least 5 visits to their study doctor, and 3 overnight stays for a sleep study. Compensation for time and travel may be available.

NOW RECRUITING pregnant people. If you are taking (or plan to take) any medication while pregnant, we strongly encourage you to participate in Pregnancy Registries to help further knowledge about medication safety during pregnancy. You can find a list of these Pregnancy Registries in the U.S. HERE. For pregnancy registries in other countries, ask your doctor(s) to direct you (and then please share this information with the HF at info@hypersomniafoundation.org). See also HF's web page Parenthood and Pregnancy: Considerations for People Who Have Hypersomnias.

The Nuvigil and Provigil Pregnancy Registry is NOW RECRUITING pregnant people with narcolepsy, sleep apnea, and shift work disorder in the U.S.: CLICK HERE.

RECRUITMENT COMPLETE as of April 2023 for adults (18 and over) with IH: CLICK HERE.

The INTUNE study is being conducted by Harmony Biosciences to evaluate the safety and efficacy of pitolisant, an investigational medication for treating excessive daytime sleepiness (EDS) in people with idiopathic hypersomnia age 18 years or older.

This study is also evaluating the effect of pitolisant on overall symptoms and severity of IH, sleep inertia, cognition, and general sleep-related impairment.

This clinical study consists of a screening period (up to 28 days), an 8-week Open-Label Phase in which all eligible study participants will receive pitolisant, followed by a 4-week Double-Blind Randomized Withdrawal Phase in which study participants and doctors won’t know who is receiving pitolisant or placebo (a tablet that does not contain study drug).

For more information or to find a participating clinical site visit: NCT05156047 at clinicaltrials.gov or www.intuneihstudy.com/.

Contact Harmony Biosciences by email at clinicaltrials@harmonybiosciences.com.

RECRUITMENT COMPLETED as of April 2023 for 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.”

RECRUITMENT COMPLETE as of June 2022 for adults age 18-60 with IH in FRANCE: CLICK HERE. This study, sponsored by the University Hospital in Montpellier, France, will evaluate the efficacy of sodium oxybate (marketed as Xyrem) on excessive daytime sleepiness in people with idiopathic hypersomnia.

RECRUITMENT COMPLETE as of June 2022 for people age 16 and up with narcolepsy type 1 or 2 in the U.S.: CLICK HERE. The Restore study is an open label study of FT218, a once-nightly formulation of sodium oxybate in people with narcolepsy. This study is evaluating the long-term safety and tolerability of a once-nightly formulation of sodium oxybate for extended-release oral suspension (FT218) and the ability to switch from twice-nightly immediate release sodium oxybate to once-nightly FT218 for people with narcolepsy. For more information or to find a participating clinical site visit https://clinicaltrials.gov/ct2/show/NCT04451668.

As of March 1, 2021, the U.S. FDA has accepted Avadel’s New Drug Application for once-nightly FT218 for review and assigned a target Prescription Drug User Fee Act action date of October 15, 2021. Check out the press release.

For information on the prior phase 3 clinical trial, CLICK HERE (and check out this Aug. 2021 journal article). Also, see Avadel Pharmaceuticals Announces Submission of New Drug Application for FT218 to the FDA (December 2020).

RECRUITMENT COMPLETE as of June 2022 for adults age 18 to 65 with narcolepsy (with or without cataplexy) in the U.S.: CLICK HERE. “This is a double-blind, randomized, placebo-controlled, multicenter trial of NLS-2 in adult patients with narcolepsy. The study will enroll approximately 60 patients and eligible patients will be treated to receive either NLS-2 or placebo for 4-weeks.”

RECRUITMENT COMPLETE as of April 2022 for people with narcolepsy (both with and without cataplexy): CLICK HERE

This is the Nexus Narcolepsy registry, a joint venture of Jazz Pharmaceuticals, Narcolepsy Network, and Wake Up Narcolepsy. See ClinicalTrials.gov.

NOW ENROLLING adults (18 and over) with IH: CLICK HERE.

Zevra Therapeutics (formerly KemPharm) has initiated the KP1077.D01 study to evaluate the safety and efficacy of SDX, an investigational medication for treating excessive daytime sleepiness (EDS) in people with idiopathic hypersomnia age 18 years or older. SDX has a unique, slow release profile that could potentially provide stable control of sleepiness throughout the day, with low abuse potential.

In this study, researchers will evaluate the safety of the medication and its effect on symptoms and severity of IH, including the effect on EDS, sleep inertia (difficulty of waking up in the morning), and brain fog (lack of focus and mental clarity; forgetfulness and confusion).

This clinical study consists of the following:

• Initial screening period during which eligibility criteria will be evaluated, including a confirmation of patient’s IH diagnosis, if needed and during which trial participants will need to wash out all current medications.
• A five-week dose optimization phase in which all eligible study participants will receive SDX.
• A two-week double-blind randomized withdrawal phase in which study participants and physicians will not be aware of who is receiving SDX or placebo (a tablet that does not contain study drug).

Patients will be reimbursed for their participation, including coverage of travel costs to the clinical sites for all their clinic visits that are part of the clinical trial. Participants can talk to the staff of their clinical site to facilitate travel arrangements and reimbursements.

Adults (18 years of age or older) who meet the following criteria may be eligible to participate:

• Diagnosed with IH. Patients with symptoms of IH but not yet diagnosed by their doctor may also be eligible; their diagnosis will be checked in the screening period of the trial.
• Able to give informed consent.
• Have excessive daytime sleepiness as measured by sleepiness questionnaires.
• Agree to wash out all current medications that may affect daytime sleepiness or nighttime sleep.
• Are not pregnant, or do not plan to get pregnant or breastfeed during the study.

This is not a complete list of eligibility criteria. The study doctor will review all the requirements with potential participants.

For additional details about the study and enrollment, visit clincaltrials.gov (NCT05668754) or e-mail: medaffairs@zevra.com.

NOW RECRUITING individuals in the Philadelphia area with idiopathic hypersomnia (IH) and hypersomnia associated with depression or another mental health condition. 

Dr. Philip Gehrman and other researchers from the University of Pennsylvania are conducting a study to understand the relationship between the experience of hypersomnia and depression.

Participation involves:

• Virtual screening visit
• Completing questionnaires
• Two overnight sleep studies in the Penn Sleep Center in the University City neighborhood of Philadelphia.
• Daytime nap testing
• Computerized testing

Compensation for participation will be provided. 

If interested, please email Nayeli Nunez Cruz at nayeli.nunezcruz@pennmedicine.upenn.edu or call (215) 746-3068.

RECRUITMENT COMPLETE for adults (18 and over) with a family member with IH or narcolepsy:  CLICK HERE

The Behavioral Sleep Medicine Lab at Northwestern University is seeking participants for their EXPLAIN Study (Examination of Partners and Loved Ones of Adults with Idiopathic Hypersomnia and Narcolepsy), to learn how family members are affected by their loved one’s IH/narcolepsy, how family members provide support, and the types of support family members themselves need.

You may be eligible if:

• You are an adult (18 or older).
• Your partner or adult family member has IH or narcolepsy.

Eligible volunteers will be asked to complete an online survey that will take approximately 15 minutes.

Participants will not receive any compensation.

For more information, visit the EXPLAIN Study website.

Principal Investigator: Jennifer Mundt, PhD / STU00216960

NOW RECRUITING people with IH and narcolepsy (no geographical restriction, but if participants come from another time zone, they will require some adaptation to the study time zone prior to beginning the study). The project is to investigate brain regions underlying narcolepsy (with or without cataplexy) and idiopathic hypersomnia. The study includes an MRI scan session and two (non-consecutive) overnight sleep sessions at the sleep laboratory at the Institut Universitaire de Gériatrie de Montréal Research Center on Queen Mar Road in Montreal, Canada. Inclusion criteria are (1) Diagnosis of idiopathic hypersomnia or narcolepsy with or without cataplexy; (2) Age of 18 or more. Exclusion criteria are (1) Other sleep disorders; (2) Neurological disorders or head trauma; (3) Psychiatric disorders or use of psychotropic drugs; (4) Pregnancy or breastfeeding; (5) Pacemaker or metallic prosthesis. Participants will receive Can$200 of compensation if they complete the full study. For travel costs (if required, for those from other provinces or countries), up to Can$1,000 in travel reimbursements can be provided (Can$500 for travel expenses and Can$500 for accommodations). If interested, please contact Elizaveta Frolova, Research Coordinator, via email: hypersomnia.research@gmail.com.

RECRUITMENT COMPLETED as of January 2022 for adults with narcolepsy (type 1 or 2) 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.

For more information, please email ascent@northwestern.edu or call (312) 503-6627. For more information from clincialtrials.gov, CLICK HERE.

This is a follow-up to the PATH study.

NOW RECRUITING children and adolescents with narcolepsy (between the ages of 9 to 17 years) to complete a series of online surveys.

Narcolepsy symptoms in children and adolescents extend beyond sleepiness alone. Narcolepsy symptoms commonly affect academic function, social relationships, mood, and sleep. The goal of this study is to develop a clinical survey that can improve the care of pediatric narcolepsy. Participation requires permitting confirmation of diagnosis and completion of online surveys that take about 30 minutes. As a thank you, participants completing surveys will be given a $50 gift card.

For more information about participation:

• Call the Neurology Sleep Research team at 617-919-212
• Email NeuroSleepResearch-dl@childrens.harvard.edu
• Visit the Boston Children’s Hospital Sleep Center Research & Innovation website
• View the flyer

NOW ENROLLING adults (18 and over) with narcolepsy: CLICK HERE.

A research study being conducted at Canterbury Christchurch University is currently looking for people who have been diagnosed with narcolepsy (both with or without cataplexy) to complete a series of questionnaires and interactive tasks online. The process should take approximately 20 minutes to complete. The research will be looking at the relationship between mood and cognition (attention and memory). Research is open to individuals worldwide.

To participate, individuals must:

• Be 18 years of age or older
• Have a clinical diagnosis of narcolepsy
• Do not have any other health condition that affects your ability to think/concentrate (i.e. brain injury, psychiatric disorder i.e. psychosis, other neurological conditions)

For additional information, please email cn229@canterbury.ac.uk or visit the study website.

RECRUITMENT COMPLETE as of December 2021 of adults age 18 and up with myotonic dystrophy type 1 in Spain: CLICK HERE. This trial is testing the dietary supplement MYODM, which contains Theobroma cacao and caffeine for the treatment of excessive daytime sleepiness due to myotonic dystrophy type 1 (DM1).

Read more: Viewing Hypersomnias Through the Lens of Myotonic Dystrophy.

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.

SPARKLE 1501: STOPPED EARLY as of October 2021 (see Takeda's Press Release). This phase 2 study was evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising oral doses of TAK-994 in people with narcolepsy. (See also clinicaltrials.gov info HERE and HERE.)

SPARKLE 2002: RECRUITING/ENROLLMENT COMPLETED as of November 2020 (further info from ClinicalTrials.gov). This phase 1 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

RECRUITED normal/healthy adults age 18 to 40 in New Jersey, USA through Aug. 2021: CLICK HERE. This trial tested the safety, tolerability and phamacokinetics of GATE-101, a metabotropic glutamate type 2/3 receptor antagonist. All glutamate receptors bind with glutamate, an amino acid that functions as an excitatory neurotransmitter. The eventual goal of this treatment is to improve excessive sleepiness or major depressive disorder.

NOW RECRUITING people with narcolepsy with cataplexy aged 15 to 75 in the U.S. (click here) and aged 25 to 65 in Canada (click here). The clinical trial is evaluating AXS-12, an oral investigational medication (reboxetine) for cataplexy and excessive daytime sleepiness in people with narcolepsy. Other symptoms of narcolepsy as well as safety will be assessed throughout the study. Compensation for your time and travel may be available. For further information about this research study please see ClinicalTrials.gov.

RECRUITMENT COMPLETE as of May 2021 for people age 16 to 60 with narcolepsy type 1 and healthy volunteers in the U.S.: CLICK HERE. The study will assess whether a portable EEG device provides an EEG signal comparable to inpatient nPSG (noctural polysomnogram). The frequency and characteristics of wake and sleep patterns and transitions over multiple nights will also be characterized.

RECRUITMENT COMPLETE as of April 2021 for patients with idiopathic hypersomnia in the U.S. for the Real World Idiopathic Hypersomnia Outcomes Patient Survey.

Jazz Pharmaceuticals, in collaboration with Stratevi and inVibe Labs, is conducting a real-world idiopathic hypersomnia outcomes patient survey to understand patient experiences with idiopathic hypersomnia, how it impacts their lives, and their perspectives regarding their current treatment regimen. Participation involves completing an online survey. The participant may also be selected to answer several open-ended questions through an automated voice response system, which participants would call into using their mobile phone.

RECRUITMENT COMPLETE as of January 2021. Dr. Kiran Maski, pediatric neurologist and sleep medicine specialist at Boston Children’s Hospital, and a member of the Hypersomnia Foundation’s Medical Advisory Board, has developed a questionnaire that aims to improve screening for narcolepsy and idiopathic hypersomnia, with the goal of helping health care professionals identify hypersomnia symptoms quickly. Boston Children’s Hospital recruited participants between the ages of 8-18 years who had been recently diagnosed (within 1 year) with narcolepsy or idiopathic hypersomnia (or who were awaiting diagnosis with sleep study testing) to answer an online questionnaire. If you would like to learn more about the study, please send an email to Neuro Sleep Research (NeuroSleepResearch-dl@childrens.harvard.edu) or call 617-919-6212. More info HERE.

RECRUITMENT COMPLETE as of January 2021. CLICK HERE to review the study flyer.

RECRUITMENT STATUS UNKOWN as of 2020 for adults age 18-64 with major depression (with or without hypersomnolence) at The Chinese University of Hong Kong: CLICK HERE.

RECRUITED adults with post-traumatic hypersomnias at Brigham and Women’s Hospital in Boston, MA, U.S.: CLICK HERE. Withdrawn around Sep. 2020: Target study population was extremely difficult to recruit and planned study budget was exceeded.

RECRUITMENT UNKNOWN as of September 2020 for children up to age 18 Lyon, France: CLICK HERE. The goal is to evaluate the cognitive performance and the effects of narcolepsy treatments on sleep architecture and metabolic status.

RECRUITMENT STATUS UNKNOWN as of July 2020 for people age 10 and older with narcolepsy type 1 or KLS, 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.”

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 August, 2021, the U.S. FDA approved Xywav for IH. Read more HERE.

RECRUITMENT COMPLETE during 2020. The Adult Sleep Laboratory in Newcastle, NSW, Australia recruited adults with IH for a research study investigating the effectiveness of alternative therapies on sleep and daytime alertness. Visit the Sleep Health Foundation website for more information.

STUDY TERMINATED due to lack of funding as of July 2020: CLICK HERE. See also: A Pilot Study of tDCS Looks Promising for the Treatment of Idiopathic Hypersomnia.

RECRUITMENT COMPLETE as of June 2020: CLICK HERE.

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.

In 2020, Balance Therapeutics concluded this study, and the data were inconclusive. The company does not plan any further trials related to IH, and they have wound down operations.

Preliminary Results: reported at the 2019 World Sleep Congress.

• IH Symptom Diary: Development of a New Patient Reported Outcome (PRO) Measure
• Baseline Characteristics of IH Subjects Enrolled in a Clinical Trial (Arise2​)
• Are Reports of Mental Fog From Patients With IH Mediated by Objective Measures of Daytime Sleepiness?
• Characteristics of Subjects Excluded From an IH Randomized Clinical Trial (Arise​2)

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.

STUDY COMPLETED April 2020: 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.

Read more: Viewing Hypersomnias Through the Lens of Myotonic Dystrophy.

STUDY COMPLETE as of January 2020: CLICK HERE.

As of 2020, recruitment status now unknown: CLICK HERE.

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).

See Axsome's follow-up Symphony study.

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.

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: 

• December 2020 article in the Journal of Clinical Sleep Medicine: Developing a cognitive behavioral therapy for hypersomnia using telehealth: a feasibility study

RECRUITMENT STATUS unknown; study completion date was scheduled for December 2019: CLICK HERE.

RECRUITMENT STATUS unknown; study completion date was scheduled for June 2019: CLICK HERE.

Study completed May 2019. See XW Labs Initiates First-in-Human Phase I Study for Novel Narcolepsy Treatment. More information at the Australian New Zealand Clinical Trials Registry.

May 2021: XWPharma Announces Abstract for XW10172 Accepted for Presentation at the Associated Professional Sleep Societies SLEEP 2021 Annual Meeting.

"XW10172 is a conjugate of the GABAB receptor agonist, oxybate, that is in development as a modified release formulation intended to provide the desired tolerability and efficacy based on once-nightly dosing. The drug and formulation are designed to deliver oxybate without the sodium content of other products that is associated with increased cardiovascular health risk and monitoring requirements. The company plans to develop XW10172 for treatment of sleep disorders associated with neurodegenerative diseases, starting with excessive daytime sleepiness in patients with Parkinson’s disease and cataplexy and excessive daytime sleepiness in patients with narcolepsy."

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:

• April 2016: First Clinical Study Completed on Effectiveness of Possible Narcolepsy Drug THN102.
• April 2018: Hungary OKs Phase 2 Clinical Trial of Drug Candidate for Excessive Daytime Sleepiness in Parkinson’s.
• July 2018: Theranexus presents data on stimulating effect of new drug candidate. THN 102 is currently in Phase II clinical evaluation in narcolepsy and a Phase II trial in Parkinson's is also planned.
• February 2019: Theranexus Announces Preliminary Results of Phase II Trial of Thn102 on Narcolepsy Patients. "THN102's safety and tolerability profile has been deemed very satisfactory. However, the results do not indicate any difference in efficacy between THN102 (combination of modafinil and flecainide) and modafinil alone with respect to the trial’s primary endpoint (Epworth Sleepiness Scale). An over-representation of poorly responding narcoleptic patients may account for THN102's lack of difference in efficacy from the standard of care drug."
• September 2019: Efficacy of THN102 on vigilance and cognition during 40-hour total sleep deprivation in healthy subjects: Glial connexins as a therapeutic target. "THN102 seems more efficient than modafinil on vigilance, working memory and executive functions, opening new perspectives in management of hypersomnolence disorders."
• September 2020: THN102 Improves Excessive Daytime Sleepiness in Parkinson Disease.

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. Read more HERE.

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.

RECRUITMENT STATUS UNKNOWN, in S. Korea: CLICK HERE. Study was scheduled for completion May 2017. Medicine available for off-label treatment in the U.S.

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:

• June 2016 ResearchGate: ADHD Symptoms in Narcolepsy and Idiopathic Hypersomnia. And download the poster presented at SLEEP 2016
• Aug. 2016 Sleep Review article: Daytime Sleepiness and Attention Deficiencies Linked for Narcolepsy and Idiopathic Hypersomnia Patients Highlight the Need for Clinical Assessment
• 2016 SLEEP Abstract #0679: ADHD Symptoms Reported in Adults with Narcolepsy and Idiopathic Hypersomnia
• April 2017 ResearchGate: Health-Related Quality of Life in Narcolepsy and Idiopathic Hypersomnia. And download the PowerPoint presented at SLEEP 2017.
• April 2017 SLEEP Abstract #0652: Health-Related Quality of Life in Narcolepsy and Idiopathic Hypersomnia

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:

• March 2017: Narcolepsy, cataplexy, hypocretin and co-existing other health complaints: A review
• October 2017: Chronic pain in narcolepsy: investigation of differences in those with and without cataplexy

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:

• June 2017: JZP-110 Study Finds Positive Efficacy Results in Patients With Excessive Sleepiness
• March 2018: FDA Accepts Jazz Pharmaceutical’s New Drug Application for Solriamfetol (JZP-110) for Excessive Sleepiness
• April 2018: Narcolepsy Types 1 and 2 Significantly Improved With Solriamfetol Treatment
• June 2018: In the Pipeline – Narcolepsy: Solriamfetol Improves Wakefulness in Narcolepsy
• January 2019: A Randomized Study of Solriamfetol for Excessive Sleepiness in Narcolepsy. This phase 3 study evaluated the safety and efficacy of solriamfetol in narcolepsy.
• March 2019: Solriamfetol was approved by the U.S. FDA for the treatment of sleepiness caused by narcolepsy and obstructive sleep apnea.