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A Study to Access the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05972044
Recruitment Status : Recruiting
First Posted : August 2, 2023
Last Update Posted : April 26, 2024
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Study Description
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Brief Summary:
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 in adults with ADHD.

Condition or disease Intervention/treatment Phase
ADHD Drug: Solriamfetol 150 mg Drug: Solriamfetol 300 mg Drug: Placebo Phase 3

Detailed Description:
Eligible subjects must have a primary diagnosis of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to be treated with solriamfetol 150 mg, solriamfetol 300 mg, or placebo, once daily for 6 weeks.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of Solriamfetol in Adults
Actual Study Start Date : July 6, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Solriamfetol 150 mg
Up to 6 weeks
 Drug: Solriamfetol 150 mg
Solriamfetol tablets, taken once daily
Experimental: Solriamfetol 300 mg
Up to 6 weeks
 Drug: Solriamfetol 300 mg
Solriamfetol tablets, taken once daily
Placebo Comparator: Placebo
Up to 6 weeks
 Drug: Placebo
Placebo tablets, taken once daily


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline to Week 6 in the AISRS total score [ Time Frame: 6 weeks ]
    Adult ADHD Investigator Symptom Report Scale (AISRS)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary diagnosis of ADHD according to DSM-5 criteria.
  • Provides written informed consent to participate in the study before the conduct of any study procedures.
  • Male or female, aged 18 to 55 inclusive.

Exclusion Criteria:

  • Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription.
  • Unable to comply with study procedures.
  • Medically inappropriate for study participation in the opinion of the investigator.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05972044


Contacts
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Contact: Study Director 212-332-5061 cstreicher@axsome.com

Locations
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United States, California
Clinical Research Site Recruiting
Encino, California, United States, 91316
Clinical Research Site Recruiting
Garden Grove, California, United States, 92845
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Lafayette, California, United States, 94549
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Riverside, California, United States, 92506
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Santa Ana, California, United States, 92705
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Sherman Oaks, California, United States, 91403
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Torrance, California, United States, 90504
United States, Colorado
Clinical Research Site Recruiting
Colorado Springs, Colorado, United States, 80910
United States, Florida
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Gainesville, Florida, United States, 32607
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Jacksonville, Florida, United States, 32256
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Miami Lakes, Florida, United States, 33016
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Orlando, Florida, United States, 32801
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Orlando, Florida, United States, 32806
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Palm Bay, Florida, United States, 32905
United States, Georgia
Clinical Research Site Recruiting
Alpharetta, Georgia, United States, 30022
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Atlanta, Georgia, United States, 30328
Clinical Research Site Recruiting
Atlanta, Georgia, United States, 30331
Clinical Research Site Recruiting
Marietta, Georgia, United States, 30060
United States, Kansas
Clinical Research Site Recruiting
Overland Park, Kansas, United States, 66210
United States, Massachusetts
Clinical Research Site Recruiting
Boston, Massachusetts, United States, 02131
United States, Missouri
Clinical Research Site Recruiting
Saint Charles, Missouri, United States, 63304
United States, Nevada
Clinical Research Site Recruiting
Las Vegas, Nevada, United States, 89102
Clinical Research Site Recruiting
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Clinical Research Site Recruiting
Berlin, New Jersey, United States, 08009
Clinical Research Site Recruiting
Cherry Hill, New Jersey, United States, 08002
United States, New York
Clinical Research Site Recruiting
Mount Kisco, New York, United States, 10549
Clinical Research Site Recruiting
New York, New York, United States, 10128
United States, North Carolina
Clinical Research Site Recruiting
Hickory, North Carolina, United States, 28601
Clinical Research Site Recruiting
Raleigh, North Carolina, United States, 27609
United States, Ohio
Clinical Research Site Recruiting
Cincinnati, Ohio, United States, 45219
Clinical Research Site Recruiting
Kettering, Ohio, United States, 45439
United States, Oklahoma
Clinical Research Site Recruiting
Oklahoma City, Oklahoma, United States, 73118
United States, Pennsylvania
Clinical Research Site Recruiting
Media, Pennsylvania, United States, 19063
United States, South Carolina
Clinical Research Site Recruiting
North Charleston, South Carolina, United States, 29405
United States, Tennessee
Clinical Research Site Recruiting
Memphis, Tennessee, United States, 38119
United States, Texas
Clinical Research Site Recruiting
Austin, Texas, United States, 78737
Clinical Research Site Recruiting
Bellaire, Texas, United States, 77401
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Dallas, Texas, United States, 75231
Clinical Research Site Recruiting
Dallas, Texas, United States, 75243
Clinical Research Site Recruiting
San Antonio, Texas, United States, 78229
United States, Utah
Clinical Research Site Recruiting
Draper, Utah, United States, 84020
United States, Washington
Clinical Research Site Recruiting
Everett, Washington, United States, 98201
Sponsors and Collaborators
Axsome Therapeutics, Inc.
More Information
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Additional Information:

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Responsible Party: Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05972044    
Other Study ID Numbers: SOL-ADHD-301
First Posted: August 2, 2023    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Axsome Therapeutics, Inc.:
Attention deficit hyperactivity disorder
ADHD
Solriamfetol
Sunosi
 Axsome
Non-stimulant therapy
Dopamine norepinephrine reuptake inhibitor