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

February 5, 2026 updated by: Axsome Therapeutics, Inc.

A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of Solriamfetol in Adults With ADHD.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

516

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Encino, California, United States, 91316
        • Clinical Research Site
      • Garden Grove, California, United States, 92845
        • Clinical Research Site
      • Newport Beach, California, United States, 92660
        • Clinical Research Site
      • Riverside, California, United States, 92506
        • Clinical Research Site
      • Santa Ana, California, United States, 92705
        • Clinical Research Site
      • Sherman Oaks, California, United States, 91403
        • Clinical Research Site
      • Torrance, California, United States, 90504
        • Clinical Research Site
      • Walnut Creek, California, United States, 94596
        • Clinical Research Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Clinical Research Site
    • Florida
      • Clermont, Florida, United States, 34711
        • Clinical Research Site
      • Doral, Florida, United States, 33122
        • Clinical Research Site
      • Gainesville, Florida, United States, 32607
        • Clinical Research Site
      • Jacksonville, Florida, United States, 32256
        • Clinical Research Site
      • Lauderhill, Florida, United States, 33319
        • Clinical Research Site
      • Miami Lakes, Florida, United States, 33016
        • Clinical Research Site
      • Orlando, Florida, United States, 32801
        • Clinical Research Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Clinical Research Site
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Clinical Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Clinical Research Site
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • Clinical Research Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Clinical Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Clinical Research Site
      • Las Vegas, Nevada, United States, 89128
        • Clinical Research Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Clinical Research Site
      • Cherry Hill, New Jersey, United States, 08002
        • Clinical Research Site
      • Princeton, New Jersey, United States, 08540
        • Clinical Research Site
    • New York
      • Mount Kisco, New York, United States, 10549
        • Clinical Research Site
      • New York, New York, United States, 10128
        • Clinical Research Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Clinical Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Clinical Research Site
      • Kettering, Ohio, United States, 45439
        • Clinical Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Clinical Research Site
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Clinical Research Site
    • South Carolina
      • North Charleston, South Carolina, United States, 29405
        • Clinical Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Research Site
    • Texas
      • Austin, Texas, United States, 78737
        • Clinical Research Site
      • Bellaire, Texas, United States, 77401
        • Clinical Research Site
      • Dallas, Texas, United States, 75243
        • Clinical Research Site
      • Dallas, Texas, United States, 75251
        • Clinical Research Site
      • San Antonio, Texas, United States, 78229
        • Clinical Research Site
    • Utah
      • Draper, Utah, United States, 84020
        • Clinical Research Site
    • Washington
      • Everett, Washington, United States, 98201
        • Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline to Week 6 in the AISRS total score
Time Frame: 6 weeks
Adult ADHD Investigator Symptom Report Scale (AISRS)
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axsome Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2023

Primary Completion (Actual)

February 7, 2025

Study Completion (Actual)

March 14, 2025

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOL-ADHD-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ADHD

Clinical Trials on Solriamfetol 150 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe