Clinical trials: sponsored by Axsome Therapeutics, Inc.
Fibromyalgia
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
This is a Phase 3, multi-center, 52-week, open-label trial to evaluate the long-term safety and efficacy of AXS-14 in the management of fibromyalgia.
- Trial name
- NCT07637162
- Testing
- AXS-14 (esreboxetine)
- Where
- 35 sites in United States
- Volunteers
- 300 people
- Sponsor
- Axsome Therapeutics, Inc.
Smoking Cessation
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
This study is a Phase 3, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group trial to evaluate the efficacy and safety of AXS-05 compared to placebo and bupropion for smoking cessation in adults.
- Trial name
- SUMMIT (NCT07766655)
- Testing
- AXS-05 (dextromethorphan-bupropion), Bupropion
- Where
- 26 sites in United States
- Volunteers
- 705 people
- Sponsor
- Axsome Therapeutics, Inc.
ADHD
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-3)
This study is a Phase 3, multi-center, randomized, 6-week, double-blind, placebo-controlled, parallel-group trial to assess the efficacy and safety of solriamfetol in adolescents aged 12 to <18 years with ADHD.
- Trial name
- NCT07717892
- Testing
- Solriamfetol Dose A, Solriamfetol Dose B
- Where
- 28 sites in United States
- Volunteers
- 468 people
- Sponsor
- Axsome Therapeutics, Inc.
Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
CLARITY (Clinical Assessment of Response in the Treatment of Depression with Daytime Sleepiness Using Solriamfetol) is a Phase 3, double-blind, placebo-controlled, multicenter randomized withdrawal trial in patients with major…
- Trial name
- CLARITY (NCT07484217)
- Testing
- Solriamfetol 150 MG
- Where
- 40 sites in United States
- Volunteers
- 508 people
- Sponsor
- Axsome Therapeutics, Inc.
ADHD
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
This study is a Phase 3, multi-center, open-label trial to evaluate the long-term safety of solriamfetol in children and adolescents with ADHD.
- Trial name
- NCT07773883
- Testing
- Solriamfetol
- Where
- 7 sites in United States
- Volunteers
- 300 people
- Sponsor
- Axsome Therapeutics, Inc.
ADHD
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
This study is a Phase 3, multi-center, randomized, 6-week, double-blind, placebo-controlled, parallel-group trial to assess the efficacy and safety of solriamfetol in children aged 6 to <12 years with ADHD.
- Trial name
- NCT07717879
- Testing
- Solriamfetol Dose A, Solriamfetol Dose B
- Where
- 30 sites in United States
- Volunteers
- 468 people
- Sponsor
- Axsome Therapeutics, Inc.
Narcolepsy, Obstructive Sleep Apnea
SUNOSI® (Solriamfetol) Pregnancy Registry
The SUNOSI (solriamfetol) Pregnancy Registry is a US- and Canada-based prospective, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep…
- Conditions
- Narcolepsy, Obstructive Sleep Apnea, Pregnant Women and Their Offspring
- Trial name
- NCT06413420
- Testing
- Sunosi (solriamfetol), Other prescription wake-promoting medications or stimulants, No treatment
- Where
- 2 sites in United States
- Volunteers
- 1,731 people
- Sponsor
- Axsome Therapeutics, Inc.
Fibromyalgia
Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
The study is a Phase 3, double-blind, placebo-controlled, randomized withdrawal study to assess the efficacy and safety of AXS-14 in the management of fibromyalgia.
- Trial name
- FORWARD (NCT07398417)
- Testing
- AXS-14 (Esreboxetine)
- Where
- 53 sites in United States
- Volunteers
- 620 people
- Sponsor
- 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.
Binge-Eating Disorder
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder
This is a Phase 3, multi-center, open-label and randomized withdrawal study to evaluate the long-term safety and efficacy of solriamfetol in the treatment of binge eating disorder (BED) in adults.
- Trial name
- NCT06878976
- Testing
- Solriamfetol
- Where
- 33 sites in United States
- Volunteers
- 236 people
- Sponsor
- Axsome Therapeutics, Inc.
Binge-Eating Disorder
Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol
ENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol…
- Trial name
- ENGAGE (NCT06413433)
- Testing
- Solriamfetol 150 mg, Solriamfetol 300 mg
- Where
- 45 sites in United States
- Volunteers
- 450 people
- Sponsor
- Axsome Therapeutics, Inc.
Excessive Sleepiness, Shift-work Disorder
Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
SUSTAIN (Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and…
- Trial name
- NCT06568367
- Testing
- Solriamfetol 150 mg, Solriamfetol 300 mg
- Where
- 49 sites in United States, Canada
- Volunteers
- 520 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.
Narcolepsy, Cataplexy
A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy
This study is a multi-center, double-blind, placebo-controlled, randomized Phase 3 trial to assess the safety and efficacy of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
- Trial name
- SYMPHONY (NCT05059223)
- Testing
- AXS-12 (reboxetine)
- Where
- 50 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- Axsome Therapeutics, Inc.
ADHD
A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)
FOCUS (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol…
- Trial name
- NCT05972044
- Testing
- Solriamfetol 150 mg, Solriamfetol 300 mg
- Where
- 42 sites in United States
- Volunteers
- 516 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.
Major Depressive Disorder
Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol
PARADIGM (Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the safety and efficacy of solriamfetol for the…
- Trial name
- PARADIGM (NCT06360419)
- Testing
- Solriamfetol 300 mg
- Where
- 40 sites in United States
- Volunteers
- 346 people
- Sponsor
- Axsome Therapeutics, Inc.