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ClinicalTrials.gov public records Last synced Oct 16, 2026, 4:14 PM EDT

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Showing 1–24 of 41 matching trials from the live ClinicalTrials.gov search.
Filters: Sponsor: Axsome Therapeutics, Inc. Clear all
Completed Phase 3 Interventional

A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE)

NCT05113745
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Nov 13, 2025 · Synced Oct 16, 2026, 4:14 PM EDT
Recruiting Phase 3 Interventional

Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)

NCT07717879
View directory record Official record
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
30
States / cities
Dothan, Alabama • Little Rock, Arkansas • Anaheim, California + 26 more
Source: ClinicalTrials.gov public record
Updated Oct 13, 2026 · Synced Oct 16, 2026, 4:14 PM EDT
Completed Phase 3 Interventional Results available

A Trial of AXS-05 in Patients With Major Depressive Disorder

NCT04019704
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Oct 12, 2022 · Synced Oct 16, 2026, 4:14 PM EDT
Terminated Phase 2 Interventional Results available

Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)

NCT04634669
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jan 28, 2026 · Synced Oct 16, 2026, 4:14 PM EDT
Completed Phase 2 Interventional Results available

Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)

NCT03881852
View directory record Official record
Conditions
Narcolepsy, Cataplexy Narcolepsy, Excessive Sleepiness
Interventions
AXS-12 (Reboxetine), Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years to 70 Years
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019
U.S. locations
14
States / cities
Birmingham, Alabama • Alameda, California • Santa Ana, California + 11 more
Source: ClinicalTrials.gov public record
Updated Jun 15, 2026 · Synced Oct 16, 2026, 4:14 PM EDT
Completed Phase 3 Interventional

Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol

NCT06360419
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jan 5, 2026 · Synced Oct 16, 2026, 4:14 PM EDT
Recruiting Phase 3 Interventional

Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol

NCT07484217
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Oct 13, 2026 · Synced Oct 16, 2026, 4:14 PM EDT
Completed Phase 3 Interventional

A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)

NCT05972044
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Feb 10, 2026 · Synced Oct 16, 2026, 4:14 PM EDT
Not listed Phase 3 Interventional

CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1

NCT02504008
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Mar 23, 2018 · Synced Oct 16, 2026, 4:14 PM EDT
Completed Phase 3 Interventional

A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation

NCT04947553
View directory record Official record
Conditions
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, Psychomotor
Interventions
AXS-05 (dextromethorphan-bupropion), Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
65 Years to 90 Years
Enrollment
456 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
45
States / cities
Peoria, Arizona • Tempe, Arizona • Long Beach, California + 35 more
Source: ClinicalTrials.gov public record
Updated Dec 8, 2025 · Synced Oct 16, 2026, 4:14 PM EDT
Completed Phase 3 Interventional Results available

A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation

NCT05557409
View directory record Official record
Conditions
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation
Interventions
AXS-05, Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
65 Years to 90 Years
Enrollment
408 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
53
States / cities
Peoria, Arizona • Tempe, Arizona • Tucson, Arizona + 43 more
Source: ClinicalTrials.gov public record
Updated Aug 13, 2026 · Synced Oct 16, 2026, 4:14 PM EDT
Completed Phase 3 Interventional Results available

Initiating Early Control of Migraine Pain and Associated Symptoms

NCT04163185
View directory record Official record
Conditions
Migraine
Interventions
AXS-07 (MoSEIC meloxicam and rizatriptan), Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
302 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
41
States / cities
Birmingham, Alabama • Mobile, Alabama • Colton, California + 37 more
Source: ClinicalTrials.gov public record
Updated Jan 28, 2026 · Synced Oct 16, 2026, 4:14 PM EDT
Not listed Phase 3 Interventional

A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions

NCT02746068
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jan 10, 2019 · Synced Oct 16, 2026, 4:14 PM EDT
Recruiting No phase listed Observational

SUNOSI® (Solriamfetol) Pregnancy Registry

NCT06413420
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Oct 5, 2026 · Synced Oct 16, 2026, 4:14 PM EDT
Recruiting Phase 3 Interventional

Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)

NCT07766655
View directory record Official record
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
26
States / cities
Little Rock, Arkansas • Lemon Grove, California • Long Beach, California + 22 more
Source: ClinicalTrials.gov public record
Updated Oct 13, 2026 · Synced Oct 16, 2026, 4:14 PM EDT
Recruiting Phase 3 Interventional

Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol

NCT06413433
View directory record Official record
Conditions
Binge-Eating Disorder
Interventions
Solriamfetol 150 mg, Solriamfetol 300 mg, Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
450 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
44
States / cities
Encino, California • Garden Grove, California • Long Beach, California + 38 more
Source: ClinicalTrials.gov public record
Updated Jul 28, 2026 · Synced Oct 16, 2026, 4:14 PM EDT
Completed Phase 2 Interventional Results available

Assessing Symptomatic Clinical Episodes in Depression

NCT03595579
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Sep 24, 2021 · Synced Oct 16, 2026, 4:14 PM EDT
Completed Phase 2 Interventional

Mechanistic Evaluation of Response in TRD (MERIT)

NCT04608396
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jul 12, 2022 · Synced Oct 16, 2026, 4:14 PM EDT
Completed Phase 4 Interventional Results available

Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study

NCT04789174
View directory record Official record
Conditions
Excessive Daytime Sleepiness, Obstructive Sleep Apnea, Impaired Cognitive Function
Interventions
Solriamfetol, Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
59 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
15
States / cities
Los Angeles, California • Santa Ana, California • Jacksonville, Florida + 11 more
Source: ClinicalTrials.gov public record
Updated Jan 26, 2026 · Synced Oct 16, 2026, 4:14 PM EDT
Completed Phase 3 Interventional

Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor (EMERGE)

NCT05550207
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Dec 2, 2025 · Synced Oct 16, 2026, 4:14 PM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

AXS-05 Phase II Trial on Smoking Behavior

NCT03471767
View directory record Official record
Conditions
Smoking Cessation, Smoking, Cigarette, Nicotine Dependence
Interventions
AXS-05, Bupropion SR
Drug
Lead sponsor
James Davis
Other
Eligibility
18 Years and older
Enrollment
58 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018 – 2019
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Dec 19, 2022 · Synced Oct 16, 2026, 4:14 PM EDT
Completed Phase 3 Interventional Results available

Maximizing Outcomes in Treating Acute Migraine

NCT03896009
View directory record Official record
Conditions
Migraine
Interventions
AXS-07 (MoSEIC meloxicam and rizatriptan), Meloxicam, Rizatriptan, Placebo
Drug
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
1,594 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019
U.S. locations
85
States / cities
Birmingham, Alabama • Mobile, Alabama • Phoenix, Arizona + 80 more
Source: ClinicalTrials.gov public record
Updated Aug 24, 2023 · Synced Oct 16, 2026, 4:14 PM EDT
Completed Phase 3 Interventional Results available

Open-Label Safety Study of AXS-05 in Subjects With Depression

NCT04039022
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Oct 12, 2022 · Synced Oct 16, 2026, 4:14 PM EDT
Recruiting Phase 3 Interventional

Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)

NCT06568367
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jul 24, 2026 · Synced Oct 16, 2026, 4:14 PM EDT