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

Last updated: April 1, 2025
Sponsor: Axsome Therapeutics, Inc.
Overall Status: Completed

Phase

3

Condition

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Williams Syndrome

Treatment

Placebo

Solriamfetol 300 mg

Solriamfetol 150 mg

Clinical Study ID

NCT05972044
SOL-ADHD-301
  • Ages 18-55
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Primary diagnosis of ADHD according to DSM-5 criteria.

  • Provides written informed consent to participate in the study before the conduct ofany study procedures.

  • Male or female, aged 18 to 55 inclusive.

Exclusion

Exclusion Criteria:

  • Prior exposure to solriamfetol/Sunosi, through either a clinical study orprescription.

  • Unable to comply with study procedures.

  • Medically inappropriate for study participation in the opinion of the investigator.

Study Design

Total Participants: 516
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
July 06, 2023
Estimated Completion Date:
March 14, 2025

Study 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.

Connect with a study center

  • Clinical Research Site

    Encino, California 91316
    United States

    Site Not Available

  • Clinical Research Site

    Garden Grove, California 92845
    United States

    Site Not Available

  • Clinical Research Site

    Lafayette, California 94549
    United States

    Site Not Available

  • Clinical Research Site

    Newport Beach, California 92660
    United States

    Site Not Available

  • Clinical Research Site

    Riverside, California 92506
    United States

    Site Not Available

  • Clinical Research Site

    Santa Ana, California 92705
    United States

    Site Not Available

  • Clinical Research Site

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Clinical Research Site

    Torrance, California 90504
    United States

    Site Not Available

  • Clinical Research Site

    Walnut Creek, California 94596
    United States

    Site Not Available

  • Clinical Research Site

    Colorado Springs, Colorado 80910
    United States

    Site Not Available

  • Clinical Research Site

    Clermont, Florida 34711
    United States

    Site Not Available

  • Clinical Research Site

    Doral, Florida 33122
    United States

    Site Not Available

  • Clinical Research Site

    Gainesville, Florida 32607
    United States

    Site Not Available

  • Clinical Research Site

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Clinical Research Site

    Lauderhill, Florida 33319
    United States

    Site Not Available

  • Clinical Research Site

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Clinical Research Site

    Orlando, Florida 32801
    United States

    Site Not Available

  • Clinical Research Site

    Palm Bay, Florida 32905
    United States

    Site Not Available

  • Clinical Research Site

    Alpharetta, Georgia 30022
    United States

    Site Not Available

  • Clinical Research Site

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Clinical Research Site

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Clinical Research Site

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Clinical Research Site

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • Clinical Research Site

    Saint Charles, Missouri 63304
    United States

    Site Not Available

  • Clinical Research Site

    Lincoln, Nebraska 68526
    United States

    Site Not Available

  • Clinical Research Site

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Clinical Research Site

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Clinical Research Site

    Cherry Hill, New Jersey 08002
    United States

    Site Not Available

  • Clinical Research Site

    Princeton, New Jersey 08540
    United States

    Site Not Available

  • Clinical Research Site

    Mount Kisco, New York 10549
    United States

    Site Not Available

  • Clinical Research Site

    New York, New York 10128
    United States

    Site Not Available

  • Clinical Research Site

    Hickory, North Carolina 28601
    United States

    Site Not Available

  • Clinical Research Site

    Raleigh, North Carolina 27609
    United States

    Site Not Available

  • Clinical Research Site

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Clinical Research Site

    Kettering, Ohio 45439
    United States

    Site Not Available

  • Clinical Research Site

    Oklahoma City, Oklahoma 73116
    United States

    Site Not Available

  • Clinical Research Site

    Media, Pennsylvania 19063
    United States

    Site Not Available

  • Clinical Research Site

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Clinical Research Site

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Clinical Research Site

    Austin, Texas 78737
    United States

    Site Not Available

  • Clinical Research Site

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Clinical Research Site

    Dallas, Texas 75251
    United States

    Site Not Available

  • Clinical Research Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Clinical Research Site

    Draper, Utah 84020
    United States

    Site Not Available

  • Clinical Research Site

    Everett, Washington 98201
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.