Clinical trials: sponsored by Axsome Therapeutics, Inc.
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation
This trial was a multi-center, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of AXS-05 compared to placebo for the treatment of agitation associated with Alzheimer's disease.
- Conditions
- Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation
- Trial name
- ADVANCE-2 (NCT05557409)
- Testing
- AXS-05
- Where
- 55 sites in United States, Puerto Rico
- Volunteers
- 408 people
- Sponsor
- Axsome Therapeutics, Inc.
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease
An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study
The primary objective of this open-label extension trial was to evaluate the long-term safety of AXS-05 for the treatment of Alzheimer's disease agitation in subjects that participated in ADVANCE-2 or ACCORD-2.
- Conditions
- Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, Psychomotor
- Trial name
- NCT06736509
- Testing
- AXS-05 (dextromethorphan-bupropion)
- Where
- 22 sites in United States, Puerto Rico
- Volunteers
- 139 people
- Sponsor
- Axsome Therapeutics, Inc.
Narcolepsy, Cataplexy Narcolepsy
Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)
CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) is a Phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter trial of AXS-12 in patients with narcolepsy.
- Conditions
- Narcolepsy, Cataplexy Narcolepsy, Excessive Sleepiness
- Trial name
- CONCERT (NCT03881852)
- Testing
- AXS-12 (Reboxetine)
- Where
- 14 sites in United States
- Volunteers
- 21 people
- Sponsor
- Axsome Therapeutics, Inc.
Treatment Resistant Depression, Major Depressive Disorder
Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)
This study is a multi-center, open-label trial to evaluate the long-term safety and efficacy of AXS-05 in subjects with major depressive disorder with prior treatment failures
- Trial name
- NCT04634669
- Testing
- AXS-05 (dextromethorphan-bupropion)
- Where
- 20 sites in United States
- Volunteers
- 181 people
- Sponsor
- Axsome Therapeutics, Inc.
Migraine
Initiating Early Control of Migraine Pain and Associated Symptoms
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
- INTERCEPT (NCT04163185)
- Testing
- AXS-07 (MoSEIC meloxicam and rizatriptan)
- Where
- 41 sites in United States
- Volunteers
- 302 people
- Sponsor
- Axsome Therapeutics, Inc.
Excessive Daytime Sleepiness, Obstructive Sleep Apnea
Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study
The purpose of study JZP110-405 is to determine whether solriamfetol is effective at improving cognitive function in participants with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) plus impaired…
- Conditions
- Excessive Daytime Sleepiness, Obstructive Sleep Apnea, Impaired Cognitive Function
- Trial name
- SHARP (NCT04789174)
- Testing
- Solriamfetol
- Where
- 28 sites in United States, Canada and 4 more
- Volunteers
- 59 people
- Sponsor
- Axsome Therapeutics, Inc.
Excessive Sleepiness, Shift-work Disorder
Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder
In this research study the investigators want to learn more about whether the medication Solriamfetol improves daytime sleepiness in workers who start work at very early times (between 3 and 6am).
- Trial name
- NCT04788953
- Testing
- Solriamfetol Oral Tablet
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Charles A. Czeisler, PhD, MD
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.
Smoking Cessation, Smoking, Cigarette
AXS-05 Phase II Trial on Smoking Behavior
This research study is designed with the purpose of evaluating a new drug, combination Dextromethorphan-Bupropion (AXS-05), for its effects on smoking behavior.
- Conditions
- Smoking Cessation, Smoking, Cigarette, Nicotine Dependence
- Trial name
- NCT03471767
- Testing
- AXS-05, Bupropion SR
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- James Davis
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.
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.
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.