Clinical trials: sponsored by Axsome Therapeutics, Inc.
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease
A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation
This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.
- Conditions
- Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, Psychomotor
- Trial name
- ACCORD-2 (NCT04947553)
- Testing
- AXS-05 (dextromethorphan-bupropion)
- Where
- 47 sites in United States, Canada and 1 more
- Volunteers
- 456 people
- Sponsor
- Axsome Therapeutics, Inc.
Migraine
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)
This is a multicenter, open-label trial to evaluate the efficacy and safety of AXS-07 in subjects with migraine attacks and prior inadequate response to oral CGRP inhibitors.
- Trial name
- NCT05550207
- Testing
- AXS-07 (meloxicam-rizatriptan)
- Where
- 31 sites in United States
- Volunteers
- 100 people
- Sponsor
- Axsome Therapeutics, Inc.
Narcolepsy, Cataplexy
A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE)
This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
- Trial name
- NCT05113745
- Testing
- AXS-12 (reboxetine)
- Where
- 25 sites in United States, Canada
- Volunteers
- 68 people
- Sponsor
- Axsome Therapeutics, Inc.
Major Depressive Disorder
A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
This is a randomized, double-blind, active-controlled, multi-center study to evaluate the efficacy of AXS-05, compared to bupropion, in preventing the relapse of depressive symptoms in subjects with major depressive disorder…
- Trial name
- NCT06223880
- Testing
- AXS-05, Bupropion
- Where
- 40 sites in United States
- Volunteers
- 350 people
- Sponsor
- Axsome Therapeutics, Inc.
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease
Assessing Clinical Outcomes in Alzheimer's Disease Agitation
This is a multi-center, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-05 compared to placebo in the treatment of agitation symptoms in subjects with agitation associated…
- Conditions
- Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation,Psychomotor
- Trial name
- ACCORD (NCT04797715)
- Testing
- AXS-05
- Where
- 63 sites in United States, Canada
- Volunteers
- 178 people
- Sponsor
- Axsome Therapeutics, Inc.
Migraine
Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)
MOVEMENT (Multimechanistic Treatment over Time of Migraine Symptoms) is a Phase 3 study to evaluate the long-term safety of chronic intermittent use of AXS-07 and to assess the effect of AXS-07 on migraine symptoms following…
- Trial name
- NCT04068051
- Testing
- AXS-07
- Where
- 51 sites in United States
- Volunteers
- 706 people
- Sponsor
- Axsome Therapeutics, Inc.
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease
Addressing Dementia Via Agitation-Centered Evaluation
This is a multi-center, randomized, double-blind, placebo-controlled study, to assess the efficacy and safety of AXS-05 in the treatment of agitation in patients with Alzheimer's disease.
- Conditions
- Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation,Psychomotor
- Trial name
- ADVANCE (NCT03226522)
- Testing
- AXS-05, Bupropion
- Where
- 78 sites in United States, Australia
- Volunteers
- 366 people
- Sponsor
- Axsome Therapeutics, Inc.
Migraine
Maximizing Outcomes in Treating Acute Migraine
AXS-07 is an oral, investigational medicine consisting of MoSEIC meloxicam and rizatriptan, which is being developed for the acute treatment of migraine with or without aura in adults.
- Trial name
- MOMENTUM (NCT03896009)
- Testing
- AXS-07 (MoSEIC meloxicam and rizatriptan), Meloxicam, Rizatriptan
- Where
- 85 sites in United States
- Volunteers
- 1,594 people
- Sponsor
- Axsome Therapeutics, Inc.
Narcolepsy, Obstructive Sleep Apnea
Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration
The purpose of study JZP110-401 is to evaluate solriamfetol pharmacokinetics (PK) in the breast milk and plasma of healthy postpartum women following the administration of the drug.
- Conditions
- Narcolepsy, Obstructive Sleep Apnea, Excessive Daytime Somnolence, Excessive Sleepiness
- Trial name
- NCT05008341
- Testing
- Solriamfetol 150 mg Oral Tablet
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Axsome Therapeutics, Inc.
Major Depressive Disorder, Treatment Resistant Depression
Open-Label Safety Study of AXS-05 in Subjects With Depression
An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.
- Conditions
- Major Depressive Disorder, Treatment Resistant Depression, Depression
- Trial name
- NCT04039022
- Testing
- AXS-05 (dextromethorphan and bupropion) oral tablets
- Where
- 51 sites in United States
- Volunteers
- 876 people
- Sponsor
- Axsome Therapeutics, Inc.
Depression, Major Depressive Disorder
A Trial of AXS-05 in Patients With Major Depressive Disorder
A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).
- Trial name
- GEMINI (NCT04019704)
- Testing
- AXS-05
- Where
- 43 sites in United States
- Volunteers
- 327 people
- Sponsor
- Axsome Therapeutics, Inc.
Treatment Resistant Depression, Major Depressive Disorder
Mechanistic Evaluation of Response in TRD (MERIT)
To evaluate the relapse prevention of AXS-05 relative to placebo in subjects with treatment resistant depression (TRD). This is a randomized, double-blind, placebo-controlled study to evaluate AXS-05 compared to placebo in…
- Trial name
- MERIT (NCT04608396)
- Testing
- AXS-05
- Where
- 20 sites in United States
- Volunteers
- 44 people
- Sponsor
- Axsome Therapeutics, Inc.
Major Depressive Disorder
Assessing Symptomatic Clinical Episodes in Depression
Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.
- Trial name
- ASCEND (NCT03595579)
- Testing
- AXS-05, Bupropion
- Where
- 4 sites in United States
- Volunteers
- 97 people
- Sponsor
- Axsome Therapeutics, Inc.
Major Depressive Disorder, Treatment Resistant Depression
An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent Patients
The TARGET study is an active-controlled evaluation of AXS-05 compared to bupropion in patients with treatment-resistant major depressive disorder (MDD) who are adherent to study drug.
- Trial name
- TARGET (NCT04971291)
- Testing
- AXS-05, Bupropion SR
- Where
- United States
- Volunteers
- 312 people
- Sponsor
- Axsome Therapeutics, Inc.
Treatment Resistant Major Depressive Disorder
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder
To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with treatment resistant major depressive disorder (MDD).
- Trial name
- STRIDE-1 (NCT02741791)
- Testing
- AXS-05, Bupropion
- Where
- 74 sites in United States
- Volunteers
- 312 people
- Sponsor
- Axsome Therapeutics, Inc.
Osteoarthritis, Knee
A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions
This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the efficacy and safety of AXS-02 in subjects with knee osteoarthritis associated with bone marrow lesions.
- Trial name
- COAST-1 (NCT02746068)
- Testing
- AXS-02
- Where
- 61 sites in United States, Australia
- Volunteers
- 346 people
- Sponsor
- Axsome Therapeutics, Inc.
Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy
CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1
This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the efficacy and safety of AXS-02 in patients with CRPS-I.
- Trial name
- CREATE-1 (NCT02504008)
- Testing
- AXS-02 (oral zoledronate)
- Where
- 44 sites in United States, Australia and 2 more
- Volunteers
- 190 people
- Sponsor
- Axsome Therapeutics, Inc.