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Completed

NCT Number: NCT05972044

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

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Site, Encino, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Solriamfetol 150 MG

Drug

Solriamfetol tablets, taken once daily

Solriamfetol 300 mg

Drug

Solriamfetol tablets, taken once daily

Placebo

Drug

Placebo tablets, taken once daily

Primary outcomes

  1. Change from Baseline to Week 6 in the AISRS total score

    Time frame: 6 weeks

    Adult ADHD Investigator Symptom Report Scale (AISRS)

Sponsors and collaborators

Lead sponsor

Axsome Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 2, 2023
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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