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.
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.
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.
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.