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

Completed · Phase 3 · Has a placebo group

Conditions studied: ADHD

In brief

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.

Key facts

Study ID

NCT05972044

Run by

Axsome Therapeutics, Inc.

People needed

516

Starts

2023-07-06

Expected to finish

2025-03-14

Last updated by the study team

2026-02-10

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Research Site — Encino, California, United States
• Clinical Research Site — Garden Grove, California, United States
• Clinical Research Site — Newport Beach, California, United States
• Clinical Research Site — Riverside, California, United States
• Clinical Research Site — Santa Ana, California, United States
• Clinical Research Site — Sherman Oaks, California, United States
• Clinical Research Site — Torrance, California, United States
• Clinical Research Site — Walnut Creek, California, United States
• Clinical Research Site — Colorado Springs, Colorado, United States
• Clinical Research Site — Clermont, Florida, United States
• Clinical Research Site — Doral, Florida, United States
• Clinical Research Site — Gainesville, Florida, United States
• Clinical Research Site — Jacksonville, Florida, United States
• Clinical Research Site — Lauderhill, Florida, United States
• Clinical Research Site — Miami Lakes, Florida, United States
• Clinical Research Site — Orlando, Florida, United States
• Clinical Research Site — Marietta, Georgia, United States
• Clinical Research Site — Overland Park, Kansas, United States
• Clinical Research Site — Boston, Massachusetts, United States
• Clinical Research Site — Saint Charles, Missouri, United States
• Clinical Research Site — Lincoln, Nebraska, United States
• Clinical Research Site — Las Vegas, Nevada, United States
• Clinical Research Site — Las Vegas, Nevada, United States
• Clinical Research Site — Berlin, New Jersey, United States
• Clinical Research Site — Cherry Hill, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.