Idiopathic Hypersomnia clinical trials
The registry lists 52 studies for Idiopathic Hypersomnia across more than 10 countries. 23 are recruiting or about to start. 36 of them are mainly about Idiopathic Hypersomnia (how this is decided). Per ClinicalTrials.gov, last updated 2026-11-05.
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A study of drug A after surgery for early breast cancer
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· Sites: 4 added, including Seoul and Busan
· Enrollment: 300 → 450 participants
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Status
Who runs them
University Hospital, Montpellier (5) · Emory University (3) · Harmony Biosciences Management, Inc. (3) · Jazz Pharmaceuticals (3) · Alkermes, Inc. (2) · Balance Therapeutics (2) · Centessa Pharmaceuticals (UK) Limited (2) · Takeda (2)
What is being tested here
Drugs under test in Idiopathic Hypersomnia studies, those with the most open studies first. Medicines only given beside them are not counted. How drugs are counted
Coming up
10studies finish main data collection within a year1 of them phase 3
Studies recruiting or running, from their records. “Main data collection” ends at the primary completion date, the sponsor’s own estimate, which often moves.
All 10, phase 3 first
- Oct 2027A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) · Phase 3 · Harmony Biosciences Management, Inc.
- Nov 2026A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia · Alkermes, Inc.
- Nov 2026Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia. · University Hospital, Montpellier
- Nov 2026A Study of TAK-360 in Adults With Idiopathic Hypersomnia · Takeda
- Dec 2026A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia · Centessa Pharmaceuticals (UK) Limited
- Dec 2026Mind-wandering and Predictive Processes in Narcolepsy: a Putative Mechanism Through Covert REM Intrusions · Hospices Civils de Lyon
- Jan 2027Low Sodium Oxybate in Patients With Idiopathic Hypersomnia · Mayo Clinic
- Mar 2027Study of Sleep Inertia in Major Depressive Disorder by the Psychomotor Vigilance Task · Centre Hospitalier Universitaire de Nīmes
- Sep 2027Effect of Low Sodium Oxybate (LXB) on Autonomic Symptom Burden in Idiopathic Hypersomnia Patients With Postural Tachycardia Syndrome · Stanford University
- Sep 2027a Chronobiological Treatment Combining Evening Melatonin and Morning Light Therapy in Idiopathic Hypersomnia: a Prospective, Double Bind, Randomized, Placebo-controlled -Trial · University Hospital, Strasbourg, France
Who these studies take
Of the 17 Idiopathic Hypersomnia studies recruiting now, 4 (24%) set no upper age limit and 12 (71%) stop at 75 or younger. 2 (12%) take children under 18. 0 (0%) are for women only and 0 (0%) for men only; 4 (24%) take healthy volunteers.
| Age | Women | Men |
|---|---|---|
| 10 | 2 (12%) | 2 (12%) |
| 18 | 17 (100%) | 17 (100%) |
| 30 | 17 (100%) | 17 (100%) |
| 40 | 17 (100%) | 17 (100%) |
| 50 | 16 (94%) | 16 (94%) |
| 65 | 15 (88%) | 15 (88%) |
| 75 | 6 (35%) | 6 (35%) |
| 85 | 5 (29%) | 5 (29%) |
Across all 52 studies, recruiting or not: 65% stop at 75 or younger and 40% at 65; 15% take children; 0% are for women only and 4% for men only; 23% take healthy volunteers. From each study’s registry entry; the criteria on its page decide.
Studies
Recruiting first, then most recently updated. Showing 50 of 52. Browse all 52 → or search them.
- A Study of TAK-360 in People With Narcolepsy or Idiopathic HypersomniaRecruitingNCT07646678Phase 2/35 countries
- Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at SanfordRecruitingNCT017931681 country
- A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic HypersomniaRecruitingNCT06767683Phase 2/38 countries
- A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IHRecruitingNCT07625280Phase 31 country
- A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)RecruitingNCT07500090Phase 32 countries
- a Chronobiological Treatment Combining Evening Melatonin and Morning Light Therapy in Idiopathic Hypersomnia: a Prospective, Double Bind, Randomized, Placebo-controlled -TrialRecruitingNCT06252571Phase 21 country
- Hypersomnia in the Paediatric PopulationNot yet recruitingNCT07766343Not applicable1 country
- A Study of TAK-360 in Adults With Idiopathic HypersomniaRecruitingNCT06812078Phase 26 countries
- Cardiovascular and Cognitive Implications of Central Disorders of Hypersomnolence and Their TreatmentsEnrolling by invitationNCT053714831 country
- Deciphering the Interactions Between Food Intake, Sleepiness, and Nighttime Sleep Quality in Patients With Type 1 Narcolepsy and Idiopathic HypersomniaRecruitingNCT06484348Not applicable1 country
- Effects of Operational Naps on Blood Pressure and Performance Among Night Shift WorkersRecruitingNCT07217769Not applicable1 country
- Low Sodium Oxybate in Patients With Idiopathic HypersomniaRecruitingNCT05837091Phase 41 country
- A Study of ORX750 in Participants With Narcolepsy and Idiopathic HypersomniaRecruitingNCT06752668Phase 25 countries
- A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic HypersomniaRecruitingNCT07096674Phase 24 countries
- Association Between Slow Wave Activity and Sleep InertiaNot yet recruitingNCT074098831 country
- Study of Sleep Inertia in Major Depressive Disorder by the Psychomotor Vigilance TaskRecruitingNCT067322841 country
- A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic HypersomniaRecruitingNCT07006233Not applicable1 country
- Effect of Low Sodium Oxybate (LXB) on Autonomic Symptom Burden in Idiopathic Hypersomnia Patients With Postural Tachycardia SyndromeNot yet recruitingNCT07077278Phase 4
- Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic InsomniaNot yet recruitingNCT06644573Phase 11 country
- Mind-wandering and Predictive Processes in Narcolepsy: a Putative Mechanism Through Covert REM IntrusionsRecruitingNCT06457945Not applicable1 country
- Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.Not yet recruitingNCT06590662Phase 21 country
- International Swiss Primary Hypersomnolence and Narcolepsy Cohort StudyRecruitingNCT043309631 country
- Mainz Register of Patients With Sleep DisordersRecruitingNCT053213551 country
- Psychiatric Co-morbidities and Socio-demographic Characteristics in Patients With Idiopathic HypersomniaCompletedNCT057787211 country
- A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic HypersomniaActive, not recruitingNCT06843590Phase 28 countries
- A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic HypersomniaCompletedNCT05156047Phase 31 country
- Local Sleep in Idiopathic HypersomniaCompletedNCT06153615Not applicable1 country
- A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or NarcolepsyCompletedNCT05875974Phase 42 countries
- Clarithromycin Mechanisms in Hypersomnia SyndromesCompletedNCT04026958Phase 21 country
- Spectrometry (MRM) Versus I 125 Radioimmunoassay (RIA) for Quantification of Orexin-A of Patients With HypersomnolenceCompletedNCT05615584Not applicable1 country
- Study of SDX in Patients With Idiopathic Hypersomnia (IH)CompletedNCT05668754Phase 21 country
- Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)CompletedNCT06525077Phase 31 country
- Improving Social Relationships for Adolescents With Central Disorders of HypersomnolenceCompletedNCT06251063Not applicable1 country
- Strategic Daytime Napping Enhances Agility and Lowers Perceived Exertion But Does Not Improve Fatigue Resistance in Adolescent Soccer PlayersCompletedNCT07314645Not applicable1 country
- A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic HypersomniaCompletedNCT05458128Phase 31 country
- Sensible Sleep: Measuring Alarm and Snooze Behavior in Teens Using Wearables and SmartphonesWithdrawnNCT04786678Not applicable
- Sleep/Wake State Assessment with Non-invasive EarbudsCompletedNCT05066009Not applicable1 country
- Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic HypersomniaCompletedNCT03772314Phase 21 country
- Idiopathic HypersomniaCompletedNCT051509771 country
- Sodium Oxybate in Idiopathic HypersomniaCompletedNCT03597555Phase 2/31 country
- A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic HypersomniaCompletedNCT04091438Phase 12 countries
- A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety ExtensionCompletedNCT03533114Phase 38 countries
- Anesthetic Management of Patients With Chronic Sleep DisordersCompletedNCT048273291 country
- Delayed-release Bedtime Caffeine and Sleep Inertia Symptoms Immediately Upon AwakeningCompletedNCT04975360Not applicable1 country
- The Role of the Circadian System in Neurological Sleep-wake DisordersCompletedNCT03356938Not applicable1 country
- A Study of Oral BTD-001 in Adults With Idiopathic HypersomniaStatus unknownNCT03542851Phase 21 country
- Psychosocial Adjunctive Treatment for Hypersomnia (PATH)CompletedNCT03904238Not applicable1 country
- A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2CompletedNCT02512588Phase 21 country
- Neurophysiologic Correlates of HypersomniaCompletedNCT017193151 country
- Flumazenil for the Treatment of Primary HypersomniaCompletedNCT01183312Phase 1/21 country