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ClinicalTrials.gov public records Last synced Sep 1, 2026, 9:44 AM EDT

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Showing 1–24 of 41 matching trials from the live ClinicalTrials.gov search.
Local D1 index available.
Conditions
Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
Interventions
Solriamfetol 150 MG, Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
508 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
40
States / cities
Tucson, Arizona • Bellflower, California • Chino, California + 33 more
Conditions
ADHD
Interventions
Solriamfetol Dose A, Solriamfetol Dose B, Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
6 Years to 11 Years
Enrollment
468 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
9
States / cities
Dothan, Alabama • Little Rock, Arkansas • Coral Gables, Florida + 6 more
Conditions
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation,Psychomotor
Interventions
AXS-05, Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
65 Years to 90 Years
Enrollment
178 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
61
States / cities
Sun City, Arizona • Tucson, Arizona • Chula Vista, California + 55 more
Conditions
Multiple Sclerosis, Multiple Sclerosis Fatigue
Interventions
Solriamfetol, Placebo
Drug
Lead sponsor
Johns Hopkins University
Other
Eligibility
18 Years to 60 Years
Enrollment
46 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
1
States / cities
Baltimore, Maryland
Conditions
Osteoarthritis, Knee
Interventions
AXS-02, Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
50 Years and older
Enrollment
346 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
54
States / cities
Birmingham, Alabama • Chandler, Arizona • Phoenix, Arizona + 49 more
Conditions
Major Depressive Disorder, Treatment Resistant Depression, Depression
Interventions
AXS-05 (dextromethorphan and bupropion) oral tablets
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
876 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
51
States / cities
Phoenix, Arizona • Little Rock, Arkansas • Bellflower, California + 46 more
Conditions
Major Depressive Disorder, Treatment Resistant Depression
Interventions
AXS-05, Bupropion SR
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
312 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021
U.S. locations
1
States / cities
New York, New York
Conditions
ADHD
Interventions
Solriamfetol 150 mg, Solriamfetol 300 mg, Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
516 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
42
States / cities
Encino, California • Garden Grove, California • Newport Beach, California + 37 more
Conditions
Fibromyalgia
Interventions
AXS-14 (esreboxetine)
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
300 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
18
States / cities
Arkansas City, Arkansas • Redlands, California • Sacramento, California + 15 more
Conditions
Depression, Major Depressive Disorder
Interventions
AXS-05, Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
327 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019
U.S. locations
43
States / cities
Phoenix, Arizona • Little Rock, Arkansas • Bellflower, California + 39 more
Conditions
Smoking Cessation
Interventions
AXS-05 (dextromethorphan-bupropion), Bupropion, Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
705 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
9
States / cities
Little Rock, Arkansas • Jacksonville, Florida • Orlando, Florida + 6 more
Conditions
ADHD
Interventions
Solriamfetol Dose A, Solriamfetol Dose B, Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
12 Years to 17 Years
Enrollment
468 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
9
States / cities
Dothan, Alabama • Little Rock, Arkansas • Coral Gables, Florida + 6 more
Conditions
Excessive Sleepiness, Shift-work Disorder
Interventions
Solriamfetol 150 mg, Solriamfetol 300 mg, Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
520 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
44
States / cities
Auburn, Alabama • Cullman, Alabama • Chandler, Arizona + 37 more
Conditions
Treatment Resistant Depression, Major Depressive Disorder
Interventions
AXS-05 (dextromethorphan-bupropion)
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
181 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
20
States / cities
Little Rock, Arkansas • Redlands, California • Sherman Oaks, California + 17 more
Conditions
Migraine
Interventions
AXS-07 (meloxicam-rizatriptan)
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
31
States / cities
Colton, California • Fullerton, California • La Jolla, California + 28 more
Conditions
Treatment Resistant Major Depressive Disorder
Interventions
AXS-05, Bupropion
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
312 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
74
States / cities
Phoenix, Arizona • Little Rock, Arkansas • Anaheim, California + 71 more
Conditions
ADHD
Interventions
Solriamfetol
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
6 Years to 18 Years
Enrollment
300 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
2
States / cities
Dothan, Alabama • Maitland, Florida
Conditions
Narcolepsy, Obstructive Sleep Apnea, Pregnant Women and Their Offspring
Interventions
Sunosi (solriamfetol), Other prescription wake-promoting medications or stimulants, No treatment
Drug · Other
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
Female only
Enrollment
1,731 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2029
U.S. locations
2
States / cities
Morrisville, North Carolina • Wilmington, North Carolina
Conditions
Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
Interventions
AXS-12 (reboxetine), Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
15 Years to 75 Years
Enrollment
68 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
24
States / cities
Phoenix, Arizona • Boulder, Colorado • Colorado Springs, Colorado + 20 more
Terminated Phase 4 Interventional Accepts healthy volunteers Results available

Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder

NCT04788953
Conditions
Excessive Sleepiness, Shift-work Disorder
Interventions
Solriamfetol Oral Tablet, Placebo
Drug
Lead sponsor
Charles A. Czeisler, PhD, MD
Other
Eligibility
18 Years to 64 Years
Enrollment
84 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2024
U.S. locations
1
States / cities
Boston, Massachusetts
Conditions
Major Depressive Disorder
Interventions
Solriamfetol 300 mg, Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
346 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2025
U.S. locations
40
States / cities
Little Rock, Arkansas • Bellflower, California • Encino, California + 35 more
Conditions
Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy
Interventions
AXS-02 (oral zoledronate), Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
190 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2019
U.S. locations
29
States / cities
Tucson, Arizona • Hot Springs, Arkansas • Encinitas, California + 26 more
Conditions
Treatment Resistant Depression, Major Depressive Disorder
Interventions
AXS-05, Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
44 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
20
States / cities
Little Rock, Arkansas • Redlands, California • Sherman Oaks, California + 17 more
Completed Phase 2 Interventional Results available

Assessing Symptomatic Clinical Episodes in Depression

NCT03595579
Conditions
Major Depressive Disorder
Interventions
AXS-05, Bupropion
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
97 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
4
States / cities
Beverly Hills, California • Jacksonville, Florida • Orlando, Florida + 1 more