The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Tracking Information
First Submitted Date  ICMJE July 25, 2023
First Posted Date  ICMJE August 2, 2023
Last Update Posted Date April 26, 2024
Actual Study Start Date  ICMJE July 6, 2023
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2023)		 Change from Baseline to Week 6 in the AISRS total score [ Time Frame: 6 weeks ]
Adult ADHD Investigator Symptom Report Scale (AISRS)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Access the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)
Official Title  ICMJE A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of Solriamfetol in Adults
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE ADHD
Intervention  ICMJE
  • Drug: Solriamfetol 150 mg
    Solriamfetol tablets, taken once daily
  • Drug: Solriamfetol 300 mg
    Solriamfetol tablets, taken once daily
  • Drug: Placebo
    Placebo tablets, taken once daily
Study Arms  ICMJE
  • Experimental: Solriamfetol 150 mg
    Up to 6 weeks
    Intervention: Drug: Solriamfetol 150 mg
  • Experimental: Solriamfetol 300 mg
    Up to 6 weeks
    Intervention: Drug: Solriamfetol 300 mg
  • Placebo Comparator: Placebo
    Up to 6 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 25, 2023)		 450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Director 212-332-5061 cstreicher@axsome.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05972044
Other Study ID Numbers  ICMJE SOL-ADHD-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Axsome Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Axsome Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Axsome Therapeutics, Inc.
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP