94 completed, 21 recruiting, 11 unknown, 4 terminated. 34 Phase 3, 29 Not applicable, 24 Phase 2, 16 Phase 1, 4 Phase 4.
Follow Narcolepsy: new trials by email Literature Review of Narcolepsy trials Research Report on Narcolepsy
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 Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE) Samelisant, Placebo - Narcolepsy | Phase 3 | Recruiting | Suven Life Sciences Limited | 240 | 2026-09-01 | 2026-09-03 |
| 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 |
| Decreasing Nightmares in Adults With Narcolepsy Imagery Rehearsal Therapy (IRT) - Narcolepsy, Narcolepsy Type 1 | Not applicable | Recruiting | University of Utah | 80 | 2026-07-01 | 2026-07-15 |
| A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy) TAK-360, Placebo - Narcolepsy Type 1 | Phase 2 | Recruiting | Takeda | 92 | 2026-06-04 | 2026-06-29 |
| A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy HBS-301, Placebo - EDS, Cataplexy | Phase 3 | Recruiting | Harmony Biosciences Management, Inc. | 258 | 2026-06-04 | 2026-08-27 |
| A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence cleminorexton, Placebo - Narcolepsy Type 1, Narcolepsy Type 2 | Phase 2 / Phase 3 | Recruiting | Centessa Pharmaceuticals (UK) Limited | 222 | 2026-05-29 | 2026-10-02 |
| A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 ALKS 2680 Dose 1, ALKS 2680 Dose 2, Placebo - Narcolepsy Type 1 | Phase 3 | Recruiting | Alkermes, Inc. | 150 | 2026-04-06 | 2026-10-07 |
| A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy E2086, Placebo - Narcolepsy | Phase 2 | Recruiting | Eisai Inc. | 64 | 2026-03-26 | 2026-05-14 |
| A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy TAK-861, Placebo - Narcolepsy Type 1 (NT1), Narcolepsy With Cataplexy | Phase 3 | Active not recruiting | Takeda | 98 | 2026-01-29 | 2026-09-01 |
| Extended-release Sodium Oxybate in Children Extended-release sodium oxybate, Non-extended-release oxybates - Narcolepsy Type 1 (NT 1) | Phase 2 | Recruiting | Stanford University | 36 | 2025-10-27 | 2025-11-06 |
| 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 Trial to Test the Safety and Tolerability of Lu AH69593 in Adults That Are Healthy or Have Narcolepsy Lu AH69593, Placebo - Narcolepsy | Phase 1 | Recruiting | H. Lundbeck A/S | 104 | 2025-06-13 | 2026-08-12 |
| A Study of HBS-201 (Pitolisant Delayed-release) HBS-201 - Narcolepsy | Phase 1 | Completed | Harmony Biosciences Management, Inc. | 46 | 2025-05-21 | 2025-12-12 |
| A Study to Investigate Efficacy, Safety, Tolerability, and Pharmacokinetics of JZP441 Compared With Placebo in Participants With Narcolepsy Type 1 JZP441, Matching Placebo - Narcolepsy | Phase 1 | Terminated | Jazz Pharmaceuticals | 6 | 2025-05-13 | 2026-04-06 |
| The Impact of Light, Electrical, and Magnetic Neuroregulation Interventions on Sleep-wake Disorders Transcranial Magnetic Stimulation - Insomnia Chronic, Narcolepsy | Not applicable | Recruiting | Second Affiliated Hospital of Soochow University | 20 | 2025-02-01 | 2025-02-14 |
| Genetic and Clinical Characterization of Type 1 and 2 Narcolepsy in Adult and Pediatric Black and North African Populations saliva sampling - Narcolepsy | Not yet recruiting | Assistance Publique - Hôpitaux de Paris | 200 | 2025-01-30 | 2025-01-22 | |
| 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 |
| Study of Psychological, Sociological and Professional Factors Associated With Maintenance of Wakefulness Test STAI (State-Trait Anxiety Inventory) Scale : Psychological inventory of 20 self-report items on a 4-point scale - Narcolepsy, Obstructive Sleep Apnea (OSA) | Completed | Hospices Civils de Lyon | 103 | 2024-10-18 | 2026-06-05 |
Showing 20 of 139. Sign in to see all of them.
Disorders of Excessive Somnolence (48) · Cataplexy (30) · Idiopathic Hypersomnia (17) · Sleep Apnea, Obstructive (13) · Sleep Wake Disorders (13) · Sleep Initiation and Maintenance Disorders (7) · Sleepiness (7) · Fatigue (5) · Restless Legs Syndrome (5) · Sleep Disorders, Circadian Rhythm (5) · Parasomnias (4) · REM Sleep Behavior Disorder (4) · Sleep Apnea Syndromes (4) · Apnea (3)
Sleep Disorders, Intrinsic (139) · Dyssomnias (138) · Mental Disorders (137) · Nervous System Diseases (136) · Sleep Wake Disorders (126) · Disorders of Excessive Somnolence (91) · Pathological Conditions, Signs and Symptoms (28) · Signs and Symptoms (25) · Neurologic Manifestations (16) · Respiratory Tract Diseases (16) · Respiration Disorders (15) · Apnea (12) · Sleep Apnea Syndromes (11) · Brain Diseases (9) · Central Nervous System Diseases (9)
Modafinil (19) · Sodium Oxybate (11) · pitolisant (9) · solriamfetol (8) · Cognitive Behavioral Therapy (3) · Reboxetine (3) · Surveys and Questionnaires (3) · samelisant (3) · Clarithromycin (2) · Transcranial Magnetic Stimulation (2) · disufenton sodium (2) · 6-((3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy)-N-methyl-3-pyridinecarboxamide (1) · Actigraphy (1) · Amphetamines (1) · Blood Pressure Monitoring, Ambulatory (1)
Jazz Pharmaceuticals (17) · Bioprojet (7) · Cephalon (7) · Hospices Civils de Lyon (7) · Axsome Therapeutics, Inc. (5) · Alkermes, Inc. (4) · Harmony Biosciences Management, Inc. (4) · Takeda (4) · University Hospital, Montpellier (4) · Avadel (3) · Brigham and Women's Hospital (3) · Merck Sharp & Dohme LLC (3) · NLS Pharmaceutics (3) · Northwestern University (3) · Suven Life Sciences Limited (3)
United States (77) · France (37) · Canada (22) · Spain (14) · Italy (13) · Germany (12) · Belgium (11) · Netherlands (11) · Australia (10) · Switzerland (10) · China (7) · Czechia (7) · Finland (7) · Japan (5) · Russia (5)
Carlos Camozzi, MD (2) · Claudio Bassetti (2) · Jennifer Mundt, PhD (2) · Alexander Kuts (1) · Audrey Gabelle, MD, PhD (1) · Chad Ruoff, MD (1) · Charles Czeisler, PH.D., M.D. (1) · Claudio L Bassetti, Prof. (1) · Clete A Kushida, M.D., Ph.D. (1)
PMID 32356515, PMID 34822113, PMID 34935103, PMID 16895262, PMID 17687131, PMID 20463578, PMID 21206549, PMID 24107292, PMID 24587570, PMID 26094838, PMID 26298786, PMID 27166238, PMID 27778193, PMID 27807903, PMID 28129985, PMID 29221779, PMID 29986085, PMID 30169321, PMID 30387527, PMID 30540615, PMID 30882519, PMID 31691827, PMID 31739232, PMID 31926465, PMID 32215834, PMID 32393279, PMID 32399853, PMID 32588401, PMID 32804069, PMID 33179591, PMID 33184650, PMID 33226332, PMID 33393604, PMID 33934709, PMID 34031871, PMID 34247126, PMID 34283019, PMID 34358324, PMID 34606437, PMID 34920345, PMID 35193545, PMID 35380374, PMID 35441700, PMID 35635687, PMID 35689598, PMID 35816681, PMID 36084494, PMID 36305577, PMID 36494591, PMID 36931805
2025 (3), 2008 (2), 2005 (1), 2009 (1), 2015 (1), 2016 (1), 2019 (1), R01AG059613 (1), R01NS111280 (1), R34AT009551 (1)