Axsome Therap 
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27 Trials

   

Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
NCT04622293: A Trial of Solriamfetol in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Active, not recruiting
4
44
US
Solriamfetol Oral Tablet [Sunosi], Sunosi, Placebo
Rochester Center for Behavioral Medicine
Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
03/24
05/24
NCT04788953: Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder

Recruiting
4
110
US
Solriamfetol Oral Tablet, Sunosi, Placebo
Charles A. Czeisler, PhD, MD, Axsome Therapeutics, Inc.
Excessive Sleepiness, Shift-work Disorder
04/24
11/24
NCT04602936: Solriamfetol in Binge Eating Disorder

Recruiting
4
64
US
Solriamfetol, Sunosi, Placebo
Lindner Center of HOPE, Jazz Pharmaceuticals
Binge Eating Disorder
08/24
12/24
NCT05838430: Solriamfetol and CBT-I in Patients With Insomnia Disorder

Recruiting
4
60
US
Solriamfetol 75 MG, Cognitive Behavioral Therapy for Insomnia (CBT-I), Monitoring, Placebo
University of Pennsylvania, Axsome Therapeutics, Inc.
Insomnia
07/25
12/25
PARADIGM, NCT06360419: Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol

Recruiting
3
300
US
Solriamfetol 300 mg, Placebo
Axsome Therapeutics, Inc.
Major Depressive Disorder
12/25
12/25
ENGAGE, NCT06413433: Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol

Recruiting
3
450
US
Solriamfetol 150 mg, Solriamfetol 300 mg, Placebo
Axsome Therapeutics, Inc.
Binge-Eating Disorder
12/25
12/25
SOL-SWD-301, NCT06568367: Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)

Recruiting
3
520
US
Solriamfetol 150 mg, Solriamfetol 300 mg, Placebo
Axsome Therapeutics, Inc.
Excessive Sleepiness, Shift-work Disorder
12/26
12/26
NCT06103825: A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Solriamfetol in the Treatment of Excessive Daytime Sleepiness (EDS) in Patients With Obstructive Sleep Apnea (OSA)

Recruiting
3
204
RoW
Solriamfetol, Placebo
Ignis Therapeutics (Suzhou) Limited
Excessive Daytime Sleepiness Associated With Obstructive Sleep Apnea
09/24
10/24
NCT05972044: A Study to Access the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)

Recruiting
3
450
US
Solriamfetol 150 mg, Solriamfetol 300 mg, Placebo
Axsome Therapeutics, Inc.
ADHD
12/24
12/24
NCT04839562: A Controlled Study of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD) in Adults

Completed
2/3
66
US
Solriamfetol 75 MG, Sunosi 75 mg, Solriamfetol 150 MG, Sunosi 150 mg, Placebo
Massachusetts General Hospital
Attention Deficit Hyperactivity Disorder
01/23
01/23
SOLARIMS, NCT06170970: Solriamfetol for the Treatment of Multiple Sclerosis Fatigue

Recruiting
2
46
US
Solriamfetol, Sunosi, Placebo
Johns Hopkins University, National Multiple Sclerosis Society, Axsome Therapeutics, Inc.
Multiple Sclerosis, Multiple Sclerosis Fatigue
12/26
03/27
NCT06404086: RECOVER-SLEEP: Platform Protocol

Recruiting
2
1074
US
Modafinil, Modafinil Placebo, Solriamfetol, Solriamfetol Placebo, Melatonin, Melantonin Placebo, Tailored lighting (TL) Active, Tailored lighting (TL) Placebo
Duke University
Long COVID, Long COVID-19, Hypersomnia, Sleep Disturbance
07/25
07/25
NCT06404099: RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)

Recruiting
2
474
US
Modafinil, Modafinil Placebo, Solriamfetol, Solriamfetol Placebo
Duke University
Long COVID, Long COVID-19, Hypersomnia
11/25
11/25
SOLR-IH, NCT06590662: Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.

Not yet recruiting
2
60
Europe
Solriamfetol, Placebo
University Hospital, Montpellier
Idiopathic Hypersomnia
11/26
06/27
NCT06413420: SUNOSI® (Solriamfetol) Pregnancy Registry

Recruiting
N/A
1731
US
Sunosi (solriamfetol), Other prescription wake-promoting medications or stimulants, No treatment
Axsome Therapeutics, Inc.
Narcolepsy, Obstructive Sleep Apnea, Pregnant Women and Their Offspring
09/29
09/29
NCT05536011: WAKIX® (Pitolisant) Pregnancy Registry

Recruiting
N/A
1329
US
Pitolisant, Wakix, Comparator Products, Modafinil/armodafinil, Sodium oxybate, Oxybate mixed salts, Solriamfetol, Methylphenidate, Amphetamines
Harmony Biosciences, LLC
Pregnancy Related, Narcolepsy
06/30
06/30
Auvelity (bupropion/dextromethorphan) / Axsome Therap
NCT06223880: A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms

Recruiting
4
350
US
AXS-05, Bupropion
Axsome Therapeutics, Inc.
Major Depressive Disorder
03/26
03/26
AXS-05-AD-303, NCT04947553: A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation

Enrolling by invitation
3
300
Canada, US
AXS-05 (dextromethorphan-bupropion), Placebo
Axsome Therapeutics, Inc.
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, Psychomotor
12/24
12/24
ADVANCE-2, NCT05557409: A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation

Recruiting
3
350
US
AXS-05, Placebo
Axsome Therapeutics, Inc.
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation
06/25
06/25
NCT03450941: AXS-05 Phase II Trial on Smoking Behavior

Not yet recruiting
2
60
US
AXS-05, Bupropion/dextromethorphan, Bupropion SR, Wellbutrin SR, Zyban SR
James Davis, Axsome Therapeutics, Inc.
Smoking Cessation, Smoking, Cigarette, Nicotine Dependence
12/18
01/19
TARGET, NCT04971291: An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent Patients

Enrolling by invitation
2
312
US
AXS-05, Bupropion SR
Axsome Therapeutics, Inc.
Major Depressive Disorder, Treatment Resistant Depression
07/21
07/21
NCT05976646: Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion

Recruiting
1/2
18
US
Placebo, Auvelity
Virginia Commonwealth University, National Institute on Drug Abuse (NIDA)
Addiction, Opioid Use, Substance Use Disorders, Opioid Use Disorder
01/25
01/25
zoledronate (AXS-02) / Axsome Therap
2015-001527-22: CREATE-1 Study: CRPS Treatment Evaluation 1 Study. A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-02 (Disodium Zoledronate Tetrahydrate) Administered Orally to Subjects with Complex Regional Pain Syndrome Type I (CRPS-I)

Not yet recruiting
3
190
Europe
Disodium Zoledronate Tetrahydrate, AXS-02, Tablet
Axsome Therapeutics, Inc., Axsome Therapeutics, Inc.
Complex regional pain syndrome (CRPS-I)., Severe pain in a limb accompanied by autonomic, sensory, motor and trophic changes, Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
 
 
2015-000751-25: Zoledronic acid, an osteoporosis drug, in chronic low back pain with specific findings on magnetic resonance imaging: a randomized controlled trial Zoledronihappo, osteoporoosilääke, kroonisessa alaselkäkivussa jossa on spesifisiä löydöksiä magneettikuvauksessa: satunnaistettu kontrolloitu tutkimus

Ongoing
2
250
Europe
Disodium Zoledronate Tetrahydrate, AXS-02, Tablet
Jaro Karppinen, Axsome Therapeutics Inc.
Chronic low back pain Krooninen alaselkäkipu, Longlasting pain in the lower back Pitkäkestoinen alaselkäkipu, Diseases [C] - Musculoskeletal Diseases [C05]
 
 
reboxetine (AXS-12) / Axsome Therap
SYMPHONY, NCT05059223: A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy

Completed
3
90
Canada, US
AXS-12 (reboxetine), Placebo
Axsome Therapeutics, Inc.
Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
03/24
03/24
NCT05113745: A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy

Enrolling by invitation
3
90
Canada, US
AXS-12 (reboxetine), Placebo
Axsome Therapeutics, Inc.
Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
12/24
12/24
meloxicam/rizatriptan (AXS-07) / Axsome Therap
EMERGE, NCT05550207: Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor

Recruiting
3
100
US
AXS-07 (meloxicam-rizatriptan)
Axsome Therapeutics, Inc.
Migraine
12/24
12/24
esreboxetine (AXS-14) / Axsome Therap, Pfizer
No trials found

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