Narcolepsy clinical trials
The registry lists 157 studies for Narcolepsy across more than 10 countries. 37 are recruiting or about to start. 117 of them are mainly about Narcolepsy (how this is decided). Per ClinicalTrials.gov, last updated 2026-11-03. Counting its narrower condition Cataplexy too: 159 studies, 37 open.
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Who runs them
Jazz Pharmaceuticals (17) · Takeda (16) · Hospices Civils de Lyon (8) · Cephalon (7) · Bioprojet (7) · Axsome Therapeutics, Inc. (5) · Harmony Biosciences Management, Inc. (4) · Alkermes, Inc. (4)
What is being tested here
Drugs under test in Narcolepsy studies, those with the most open studies first. Medicines only given beside them are not counted. How drugs are counted
| Drug | Open | Phase 3 | All |
|---|---|---|---|
| Sodium Oxybate | 1 | 4 | 8 |
| Oxybate | 1 | 4 | 8 |
| JZP258 | 1 | 2 | 5 |
| Alixorexton | 1 | 1 | 3 |
| Mazindol | 1 | 1 | 3 |
| Ledasorexton | 1 | 0 | 2 |
| Samelisant | 1 | 1 | 2 |
| HBS-301 | 1 | 1 | 1 |
| TAK-360 | 1 | 0 | 1 |
| Modafinil | 0 | 7 | 10 |
Drug classes tested here Stimulants 1 open
Coming up
Studies recruiting or running, from their records. “Main data collection” ends at the primary completion date, the sponsor’s own estimate, which often moves.
The 10 nearest, phase 3 first
- Dec 2026A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy · Phase 3 · Takeda
- May 2027A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 · Phase 3 · Alkermes, Inc.
- Sep 2027A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence · Phase 3 · Centessa Pharmaceuticals (UK) Limited
- Oct 2027A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy · Phase 3 · Harmony Biosciences Management, Inc.
- Nov 2027A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE) · Phase 3 · Suven Life Sciences Limited
- Nov 2026A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2) · Takeda
- Dec 2026The Impact of Light, Electrical, and Magnetic Neuroregulation Interventions on Sleep-wake Disorders · Second Affiliated Hospital of Soochow University
- Dec 2026Epidemiology of Narcolepsy Type 1 and Type 2 in Spain · Takeda
- Feb 2027A Trial to Test the Safety and Tolerability of Lu AH69593 in Adults That Are Healthy or Have Narcolepsy · H. Lundbeck A/S
- Feb 2027A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy · Eisai Inc.
Who these studies take
Of the 30 Narcolepsy studies recruiting now, 12 (40%) set no upper age limit and 16 (53%) stop at 75 or younger. 12 (40%) take children under 18. 2 (7%) are for women only and 0 (0%) for men only; 6 (20%) take healthy volunteers.
| Age | Women | Men |
|---|---|---|
| 10 | 10 (33%) | 8 (27%) |
| 18 | 29 (97%) | 27 (90%) |
| 30 | 29 (97%) | 27 (90%) |
| 40 | 29 (97%) | 27 (90%) |
| 50 | 29 (97%) | 27 (90%) |
| 65 | 24 (80%) | 22 (73%) |
| 75 | 16 (53%) | 14 (47%) |
| 85 | 14 (47%) | 12 (40%) |
Across all 157 studies, recruiting or not: 57% stop at 75 or younger and 39% at 65; 34% take children; 3% are for women only and 1% for men only; 24% take healthy volunteers. From each study’s registry entry; the criteria on its page decide.
How long Narcolepsy studies take
Of 15 phase 2 interventional studies under Narcolepsy, half reached primary completion within 14 months of starting, counting those still running.
| Start to primary completion | Every sponsor | Industry | Non-industry |
|---|---|---|---|
| Phase 1 | 8 mo3–11 · 13 studies | — | — |
| Phase 2 | 14 mo11–44 · 15 studies | — | — |
| Phase 3 | 30 mo21–40 · 14 studies | — | — |
| Interventional, no phase | 23 mo15–42 · 21 studies | — | — |
| Observational | 61 mo14–73 · 19 studies | — | — |
Each figure is the month by which half the studies had reached primary completion, with the range in which the middle half did. Studies still running count until their last registry update; studies that stopped early are left out. Phase 1 includes early phase 1; observational means prospective or not stated, as retrospective and cross-sectional studies date a window of data rather than a study. How these figures are worked out
Studies
Recruiting first, then most recently updated. Showing 50 of 157. Browse all 157 → or search them.
- A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of HypersomnolenceRecruitingNCT07598708Phase 2/31 country
- A Study About Treatment Use in Adults With Narcolepsy Type 1 (NT1) in Europe and CanadaNot yet recruitingNCT07903220
- Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at SanfordRecruitingNCT017931681 country
- Ofatumumab in Treatment-Refractory¬ Narcolepsy Type 1RecruitingNCT07871006Phase 1/21 country
- A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic HypersomniaRecruitingNCT06767683Phase 2/38 countries
- A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)RecruitingNCT06952699Phase 27 countries
- A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IHRecruitingNCT07625280Phase 31 country
- A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1RecruitingNCT07455383Phase 310 countries
- SUNOSI® (Solriamfetol) Pregnancy RegistryRecruitingNCT064134201 country
- A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE)RecruitingNCT07540364Phase 31 country
- A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With NarcolepsyRecruitingNCT07675135Phase 32 countries
- Hypersomnia in the Paediatric PopulationNot yet recruitingNCT07766343Not applicable1 country
- A Trial to Test the Safety and Tolerability of Lu AH69593 in Adults That Are Healthy or Have NarcolepsyRecruitingNCT07613710Phase 11 country
- Temporal Interference Stimulation of Hypothalamus in Patients With Narcolepsy Type 1RecruitingNCT07727239Not applicable1 country
- Decreasing Nightmares in Adults With NarcolepsyRecruitingNCT06383806Not applicable1 country
- A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)RecruitingNCT07633301Phase 27 countries
- WAKIX® (Pitolisant) Pregnancy RegistryRecruitingNCT055360111 country
- Cardiovascular and Cognitive Implications of Central Disorders of Hypersomnolence and Their TreatmentsEnrolling by invitationNCT053714831 country
- A Phase 1, First-in-human Study of VX-433RecruitingNCT07584434Phase 11 country
- Evaluation of Social Cognition in Patient With Type 1 or Type 2 Narcolepsy Versus Patients With Idiopathic HypersomniaRecruitingNCT05773872Not applicable1 country
- A Study to Evaluate the Efficacy and Safety of E2086 in Adults With NarcolepsyRecruitingNCT07493265Phase 210 countries
- A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic HypersomniaRecruitingNCT07096674Phase 24 countries
- Proteomics and Metabolomics of Body Fluid in Patients With NarcolepsyRecruitingNCT062792471 country
- A Study of TAK-861 for the Treatment of Selected Central Hypersomnia ConditionsRecruitingNCT05816382Phase 2/312 countries
- Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation ResearchRecruitingNCT048066201 country
- Bacterial Translocation and Gut Microbiota in Type 1 Narcolepsy Patients Versus a Control PopulationRecruitingNCT062925981 country
- Extended-release Sodium Oxybate in ChildrenRecruitingNCT06809803Phase 21 country
- A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic HypersomniaRecruitingNCT07006233Not applicable1 country
- The Impact of Light, Electrical, and Magnetic Neuroregulation Interventions on Sleep-wake DisordersRecruitingNCT06797284Not applicable1 country
- Genetic and Clinical Characterization of Type 1 and 2 Narcolepsy in Adult and Pediatric Black and North African PopulationsNot yet recruitingNCT067863771 country
- Mentalizating in Adults Suffering from Narcolepsy Type 1.RecruitingNCT063360571 country
- A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1Not yet recruitingNCT05914194Phase 3
- Treating Comorbid Depression of Patients With Narcolepsy by Intermittent Theta Burst StimulationRecruitingNCT05884112Not applicable1 country
- Discovering Factors in Narcolepsy Patients' Clinical Research ExperiencesNot yet recruitingNCT05870735
- International Swiss Primary Hypersomnolence and Narcolepsy Cohort StudyRecruitingNCT043309631 country
- Mainz Register of Patients With Sleep DisordersRecruitingNCT053213551 country
- The Value of Combined Detection of Orexin-A, HLA Gene, PSG and MSLT in the Evaluation of Patients With NarcolepsyEnrolling by invitationNCT049408061 country
- A Trial of TAK-861 for the Treatment of Narcolepsy With CataplexyActive, not recruitingNCT07363720Phase 37 countries
- Epidemiology of Narcolepsy Type 1 and Type 2 in SpainActive, not recruitingNCT072990971 country
- Contribution of 7 Tesla MRI of the Hypothalamus in the Diagnosis of Type 1 NarcolepsyCompletedNCT05967832Not applicable1 country
- A Study of TAK-861 for the Treatment of Narcolepsy Type 1CompletedNCT06470828Phase 311 countries
- 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
- A Study of TAK-861 in People With Narcolepsy Type 1CompletedNCT06505031Phase 311 countries
- Spectrometry (MRM) Versus I 125 Radioimmunoassay (RIA) for Quantification of Orexin-A of Patients With HypersomnolenceCompletedNCT05615584Not applicable1 country
- Narcolepsy Nightmare StudyCompletedNCT05709873Not applicable1 country
- Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)CompletedNCT03881852Phase 21 country
- A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)CompletedNCT06358950Phase 28 countries
- Study of Psychological, Sociological and Professional Factors Associated With Maintenance of Wakefulness TestCompletedNCT065861381 country
- Imagery Control Therapy and Lucid Dreaming for REM-Related Symptoms in NarcolepsyCompletedNCT07609537Not applicable1 country