25 completed, 16 recruiting, 5 not yet recruiting, 3 unknown. 16 Phase 2, 14 Not applicable, 9 Phase 3, 3 Phase 1, 3 Phase 4.
Follow Idiopathic Hypersomnia: new trials by email Literature Review of Idiopathic Hypersomnia trials Research Report on Idiopathic Hypersomnia
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Hypersomnia in the Paediatric Population Sleepness and wakeness scale, Polysomnography, Actimetry - Wakefulness Disorder, Narcolepsy | Not applicable | Not yet recruiting | University Hospital, Montpellier | 760 | 2026-09-01 | 2026-08-14 |
| A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH Xywav, Placebo - Narcolepsy, Idiopathic Hypersomnia | Phase 3 | Recruiting | Jazz Pharmaceuticals | 120 | 2026-07-09 | 2026-10-08 |
| A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia TAK-360, Placebo - Idiopathic Hypersomnia, Narcolepsy Type 1 | Phase 2 / Phase 3 | Recruiting | Takeda | 500 | 2026-06-11 | 2026-09-18 |
| Effects of Operational Naps on Blood Pressure and Performance Among Night Shift Workers No-nap, 15-min nap, 30-min nap - Shift Work | Not applicable | Recruiting | University of Pittsburgh | 130 | 2026-05-07 | 2026-06-03 |
| A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) HBS-301 tablet, Placebo - Idiopathic Hypersomnia | Phase 3 | Recruiting | Harmony Biosciences Management, Inc. | 248 | 2026-03-16 | 2026-09-14 |
| Association Between Slow Wave Activity and Sleep Inertia Nap intervention - Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization, Sleep Inertia | Not yet recruiting | Mahidol University | 28 | 2026-02-04 | 2026-02-13 | |
| Study of Sleep Inertia in Major Depressive Disorder by the Psychomotor Vigilance Task Psychomotor vigilance task, Video-polysomnography, Sleep and activity monitoring - Major Depression, Sleep Inertia | Recruiting | Centre Hospitalier Universitaire de Nīmes | 110 | 2025-11-04 | 2025-12-11 | |
| Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia PROSOMNIA Sleep Therapy™ (PSTx), Anesthesia-Induced Sleep Therapy, Diprivan (propofol), Astra-Zeneca - Chronic Insomnia, Sleep Deprivation | Phase 1 | Not yet recruiting | Nyree Penn | 100 | 2025-11-01 | 2025-05-28 |
| Effect of Low Sodium Oxybate (LXB) on Autonomic Symptom Burden in Idiopathic Hypersomnia Patients With Postural Tachycardia Syndrome Low sodium oxybate (LXB), Placebo - Idiopathic Hypersomnia, POTS - Postural Orthostatic Tachycardia Syndrome | Phase 4 | Not yet recruiting | Stanford University | 25 | 2025-10-01 | 2025-07-25 |
| A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia ORX750 - Narcolepsy Type 1, Narcolepsy Type 2 | Phase 2 | Recruiting | Centessa Pharmaceuticals (UK) Limited | 90 | 2025-08-12 | 2026-04-16 |
| A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia Whole Food Ketogenic Diet, Whole Food Diet - Idiopathic Hypersomnia, Narcolepsy Type 1 (NT 1) | Not applicable | Recruiting | University of Sydney | 30 | 2025-06-23 | 2025-08-27 |
| A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia ALKS 2680, Placebo - Idiopathic Hypersomnia | Phase 2 | Active not recruiting | Alkermes, Inc. | 126 | 2025-05-22 | 2026-09-25 |
| A Study of TAK-360 in Adults With Idiopathic Hypersomnia TAK-360, Placebo - Idiopathic Hypersomnia | Phase 2 | Recruiting | Takeda | 96 | 2025-02-07 | 2026-07-15 |
| A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia ALKS 2680, 4mg, ALKS 2680, 6mg, ALKS 2680, 8mg - Narcolepsy Type 1, Narcolepsy Type 2 | Phase 2 / Phase 3 | Recruiting | Alkermes, Inc. | 786 | 2025-01-27 | 2026-10-09 |
| A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia ORX750, Placebo - Narcolepsy Type 1, Narcolepsy Type 2 | Phase 2 | Recruiting | Centessa Pharmaceuticals (UK) Limited | 248 | 2024-12-23 | 2026-04-27 |
| Mind-wandering and Predictive Processes in Narcolepsy: a Putative Mechanism Through Covert REM Intrusions ASRT, Questionnaires, Electrophysiological recordings - Narcolepsy Type 1, Hypersomnolence | Not applicable | Recruiting | Hospices Civils de Lyon | 180 | 2024-12-03 | 2025-01-13 |
| Deciphering the Interactions Between Food Intake, Sleepiness, and Nighttime Sleep Quality in Patients With Type 1 Narcolepsy and Idiopathic Hypersomnia Monitoring of eating behaviors, Monitoring of sleep/wake rhythm, Measure of nocturnal sleep parameters - Narcolepsy Type 1, Idiopathic Hypersomnia | Not applicable | Recruiting | Hospices Civils de Lyon | 76 | 2024-10-16 | 2026-06-03 |
| Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia. Solriamfetol, Placebo - Idiopathic Hypersomnia | Phase 2 | Not yet recruiting | University Hospital, Montpellier | 60 | 2024-09-15 | 2024-09-19 |
| a Chronobiological Treatment Combining Evening Melatonin and Morning Light Therapy in Idiopathic Hypersomnia: a Prospective, Double Bind, Randomized, Placebo-controlled -Trial - Melatonin - Active light ttherapy, - Placebo drug - Placebo light therapy - Idiopathic Hypersomnia | Phase 2 | Recruiting | University Hospital, Strasbourg, France | 72 | 2024-09-07 | 2026-08-20 |
| Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ) FT218, Placebo - Idiopathic Hypersomnia | Phase 3 | Completed | Avadel | 157 | 2024-08-01 | 2026-05-11 |
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Narcolepsy (17) · Disorders of Excessive Somnolence (16) · Sleep Wake Disorders (5) · Sleepiness (4) · Sleep Initiation and Maintenance Disorders (3) · Bipolar Disorder (2) · Cataplexy (2) · Depressive Disorder, Major (2) · Fatigue (2) · Parasomnias (2) · REM Sleep Behavior Disorder (2) · Restless Legs Syndrome (2) · Sleep Deprivation (2) · 3-Methylglutaconic Aciduria, Type V (1)
Dyssomnias (52) · Sleep Disorders, Intrinsic (52) · Mental Disorders (51) · Nervous System Diseases (51) · Sleep Wake Disorders (47) · Disorders of Excessive Somnolence (36) · Pathological Conditions, Signs and Symptoms (13) · Signs and Symptoms (13) · Neurologic Manifestations (8) · Autonomic Nervous System Diseases (2) · Bipolar and Related Disorders (2) · Brain Diseases (2) · Central Nervous System Diseases (2) · Dementia (2) · Depressive Disorder (2)
Surveys and Questionnaires (3) · Clarithromycin (2) · Polysomnography (2) · Actigraphy (1) · Adderall (1) · Blood Pressure Monitoring, Ambulatory (1) · Blood Specimen Collection (1) · Caffeine (1) · Calcium (1) · Cognitive Behavioral Therapy (1) · Diet, Ketogenic (1) · Electroencephalography (1) · Flumazenil (1) · Magnesium (1) · Modafinil (1)
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) · Hospices Civils de Lyon (2) · Lynn Marie Trotti (2) · Mayo Clinic (2) · Takeda (2) · Assistance Publique - Hôpitaux de Paris (1) · Avadel (1) · Boston Children's Hospital (1) · Centre Hospitalier Universitaire de Nīmes (1)
United States (30) · France (17) · Spain (6) · Australia (5) · Italy (5) · Canada (4) · Belgium (3) · Czechia (3) · Japan (3) · Switzerland (3) · Netherlands (2) · China (1) · Finland (1) · Germany (1) · Hong Kong (1)
Chad Ruoff, MD (2) · Lynn Marie Trotti, MD (2) · Lynn Marie Trotti, MD, MSc (2) · Christopher Drake, PhD (1) · Claudio L Bassetti, Prof. (1) · Daniel Patterson (1) · David Rye, MD, PhD (1) · David Seiden, MD (1) · David T Plante (1) · Elizabeth A Machan, PhD (1) · Eric Zhou, PhD (1)
PMID 10188130, PMID 12531174, PMID 16303153, PMID 20463578, PMID 22269988, PMID 22734577, PMID 26094838, PMID 30540615, PMID 30882519, PMID 31692489, PMID 32804069, PMID 33393604, PMID 34031871, PMID 34116386, PMID 34611208, PMID 34942138, PMID 36883238, PMID 36938627, PMID 37409509, PMID 37839272, PMID 39306601, PMID 40135693, PMID 40141767, PMID 40359459, PMID 41442817, PMID 41657285, PMID 41831073, PMID 42060037, PMID 42382222, PMID 8919196
2025 (2), 2018 (1), 2019 (1), R01NS111280 (1), R61HL172984 (1)