Axsome Therapeutics

🇺🇸United States

Country: 🇺🇸United States

Ownership: Public

Established: 2012-01-01

Employees: 545

Market Cap: $4.2B

Website: http://www.axsome.com

Introduction: Axsome Therapeutics, Inc. is a commercial-stage biopharmaceutical company, which engages in the development of novel therapies for the management of central nervous system disorders. Its portfolio consists of Products Overview and Pipeline Overview. The Products Overview includes Auvelity and Sunosi. The Pipeline Overview contain AXS-05, AXS-07, AXS-12, and ...

Clinical Trials

A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy

Phase 3

Completed

Conditions: Narcolepsy
Cataplexy
Excessive Daytime Sleepiness

Interventions: Drug: AXS-12 (reboxetine)
Drug: Placebo

First Posted Date: 2021-09-28

Last Posted Date: 2024-04-22

Lead Sponsor: Axsome Therapeutics, Inc.

Target Recruit Count: 90

Registration Number: NCT05059223

Locations: 🇨🇦
Clinical Research Site, Toronto, Ontario, Canada

Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration

Phase 1

Completed

Conditions: Obstructive Sleep Apnea
Narcolepsy
Excessive Daytime Somnolence
Excessive Sleepiness
Postpartum

Interventions: Drug: Solriamfetol 150 mg Oral Tablet

First Posted Date: 2021-08-17

Last Posted Date: 2023-04-14

Lead Sponsor: Axsome Therapeutics, Inc.

Target Recruit Count: 6

Registration Number: NCT05008341

Locations: 🇺🇸
M3-Wake Research, Inc., Raleigh, North Carolina, United States

An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent Patients

Phase 2

Conditions: Major Depressive Disorder
Treatment Resistant Depression

Interventions: Drug: AXS-05
Drug: Bupropion SR

First Posted Date: 2021-07-21

Last Posted Date: 2021-07-26

Lead Sponsor: Axsome Therapeutics, Inc.

Target Recruit Count: 312

Registration Number: NCT04971291

Locations: 🇺🇸
Axsome Research Site, New York, New York, United States

A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects with Alzheimer's Disease Agitation

Phase 3

Active, not recruiting

Conditions: Agitation in Patients with Dementia of the Alzheimer's Type
Alzheimer Disease
Agitation, Psychomotor

Interventions: Drug: AXS-05 (dextromethorphan-bupropion)
Drug: Placebo

First Posted Date: 2021-07-01

Last Posted Date: 2024-12-19

Lead Sponsor: Axsome Therapeutics, Inc.

Target Recruit Count: 300

Registration Number: NCT04947553

Locations: 🇵🇷
Clinical Research Site, San Juan, Puerto Rico

Assessing Clinical Outcomes in Alzheimer's Disease Agitation

Phase 3

Completed

Conditions: Agitation in Patients With Dementia of the Alzheimer's Type
Alzheimer Disease
Agitation,Psychomotor

Interventions: Drug: AXS-05
Drug: Placebo

First Posted Date: 2021-03-15

Last Posted Date: 2023-11-29

Lead Sponsor: Axsome Therapeutics, Inc.

Target Recruit Count: 178

Registration Number: NCT04797715

Locations: 🇨🇦
Clinical Research Site, Newmarket, Ontario, Canada

Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study

Phase 4

Completed

Conditions: Excessive Daytime Sleepiness
Obstructive Sleep Apnea
Impaired Cognitive Function

Interventions: Drug: Placebo
Drug: Solriamfetol

First Posted Date: 2021-03-09

Last Posted Date: 2022-10-17

Lead Sponsor: Axsome Therapeutics, Inc.

Target Recruit Count: 59

Registration Number: NCT04789174

Locations: 🇺🇸
FutureSearch Trials of Neuroglogy, Austin, Texas, United States
🇳🇱
Amphia Hospital, Breda, Netherlands
🇪🇸
Instiut de Reccerca Biomedica de Lledia, Lleida, Spain

and more 25 locations

Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)

Phase 2

Completed

Conditions: Treatment Resistant Depression
Major Depressive Disorder

Interventions: Drug: AXS-05 (dextromethorphan-bupropion)

First Posted Date: 2020-11-18

Last Posted Date: 2023-03-07

Lead Sponsor: Axsome Therapeutics, Inc.

Target Recruit Count: 186

Registration Number: NCT04634669

Locations: 🇺🇸
Clinical Research Site, Everett, Washington, United States

Mechanistic Evaluation of Response in TRD (MERIT)

Phase 2

Completed

Conditions: Treatment Resistant Depression
Major Depressive Disorder

Interventions: Drug: AXS-05
Drug: Placebo

First Posted Date: 2020-10-29

Last Posted Date: 2022-07-12

Lead Sponsor: Axsome Therapeutics, Inc.

Target Recruit Count: 44

Registration Number: NCT04608396

Locations: 🇺🇸
Clinical Research Site, Everett, Washington, United States

Initiating Early Control of Migraine Pain and Associated Symptoms

Phase 3

Completed

Conditions: Migraine

Interventions: Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)
Drug: Placebo

First Posted Date: 2019-11-14

Last Posted Date: 2021-04-30

Lead Sponsor: Axsome Therapeutics, Inc.

Target Recruit Count: 302

Registration Number: NCT04163185

Locations: 🇺🇸
Clinical Research Site, Charlottesville, Virginia, United States

Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)

Phase 3

Completed

Conditions: Migraine

Interventions: Drug: AXS-07

First Posted Date: 2019-08-28

Last Posted Date: 2023-10-10

Lead Sponsor: Axsome Therapeutics, Inc.

Target Recruit Count: 706

Registration Number: NCT04068051

Locations: 🇺🇸
Clinical Research Site, Seattle, Washington, United States

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