13 completed. 13 Phase 1, 1 Phase 2.
By phase and status
Follow Narcolepsy: new trials by email Literature Review of Narcolepsy trials Research Report on Narcolepsy
Trials (filtered) newest first · largest first
All 13 trials
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 |
|---|
A Study of HBS-201 (Pitolisant Delayed-release)
HBS-201 - Narcolepsy | Phase 1 | Completed | 46 | 2025-05-21 | 2025-12-12 |
A Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Participants With Narcolepsy Type 1
E2086, E2086 Placebo, Active Comparator - Narcolepsy Type 1 (NT1) | Phase 1 | Completed | 22 | 2024-06-20 | 2025-06-04 |
A Study of MK-6552 in Sleep Deprived Healthy Participants (MK-6552-003)
MK-6552, MK-6552 placebo, Modafinil - Healthy, Narcolepsy | Phase 1 | Completed | 18 | 2024-03-19 | 2024-10-01 |
A Clinical Study of MK-6552 and Modafinil in Healthy Men (MK-6552-005)
MK-6552, Modafinil - Healthy, Narcolepsy | Phase 1 | Completed | 12 | 2023-09-20 | 2024-10-30 |
Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration
Solriamfetol 150 mg Oral Tablet - Narcolepsy, Obstructive Sleep Apnea | Phase 1 | Completed | 6 | 2021-08-27 | 2023-04-14 |
Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR)
ADAIR 10 mg IR tablets, d-amphetamine sulfate, Placebo - ADHD, Narcolepsy | Phase 1 | Completed | 55 | 2020-10-05 | 2021-12-29 |
Pilot Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Abuse Liability of an Abuse-Deterrent Immediate-Release Formulation (ADAIR)
ADAIR 10mg IR capsules, Crushed d-amphetamine sulfate IR tablets - ADHD, Narcolepsy | Phase 1 | Completed | 16 | 2019-05-27 | 2020-01-18 |
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With Narcolepsy
TAK-925, Placebo - Healthy Participants, Narcolepsy | Phase 1 | Completed | 57 | 2018-11-21 | 2020-12-08 |
The Effect of Caffeine on the Narcoleptic Patients
Vivarin, Fiber - Narcolepsy | Phase 1 / Phase 2 | Completed | 16 | 2016-10-01 | 2019-03-01 |
A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
Placebo, Sodium Oxybate, JZP-386 - Narcolepsy, Excessive Daytime Sleepiness | Phase 1 | Completed | 28 | 2014-07-01 | 2015-05-29 |
This is a Study to Determine the Effect of Multiple Doses of an Investigational Drug, Taken by Mouth, in People With Narcolepsy-cataplexy. Accepting Both Males and Females Ages of 18 Years to 55 Years. This Study Will be Conducted in the US and Will Require Approximately 13 Weeks Participation.
SEP363856, Placebo - Narcolepsy | Phase 1 | Completed | 18 | 2014-06-05 | 2024-06-26 |
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
Armodafinil - Narcolepsy | Phase 1 | Completed | 40 | 2012-07-01 | 2021-11-09 |
Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes
Sodium Oxybate (Xyrem) - Narcolepsy With Cataplexy | Phase 1 | Completed | 25 | 2006-04-10 | 2022-04-08 |
Narrower conditions
Disorders of Excessive Somnolence (3) · Attention Deficit Disorder with Hyperactivity (2) · Nervous System Diseases (1) · Sleep Apnea, Obstructive (1)
Broader conditions
Dyssomnias (13) · Mental Disorders (13) · Sleep Disorders, Intrinsic (13) · Sleep Wake Disorders (13) · Nervous System Diseases (12) · Disorders of Excessive Somnolence (10) · Attention Deficit and Disruptive Behavior Disorders (2) · Neurodevelopmental Disorders (2) · Apnea (1) · Respiration Disorders (1) · Respiratory Tract Diseases (1) · Sleep Apnea Syndromes (1)
Interventions
Modafinil (3) · Sodium Oxybate (2) · Caffeine (1) · Dextroamphetamine (1) · Dietary Fiber (1) · SEP-363856 (1) · TAK-925 (1) · Tablets (1) · caffeine citrate (1) · solriamfetol (1)
Sponsors
Merck Sharp & Dohme LLC (2) · Vallon Pharmaceuticals, Inc. (2) · Axsome Therapeutics, Inc. (1) · Concert Pharmaceuticals (1) · Eisai Inc. (1) · Harmony Biosciences Management, Inc. (1) · King Saud University (1) · Otsuka Pharmaceutical Development & Commercialization, Inc. (1) · Takeda (1) · Teva Branded Pharmaceutical Products R&D, Inc. (1) · UCB Pharma SA (1)
Countries
United States (8) · Canada (2) · Belgium (1) · Finland (1) · Japan (1) · Saudi Arabia (1) · United Kingdom (1)
Top investigators
LuAnn Sabounjian (1) · Mona S Aldosari, Masteral (1) · Timothy Whitaker, M (1) · Timothy Whitaker, MD (1)
Results publications
PMID 32215834, PMID 37209427
NIH funding
2005 (1)