A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)
A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of Solriamfetol in Adults With ADHD.
1 other identifier
interventional
516
1 country
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2023
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 6, 2023
CompletedFirst Submitted
Initial submission to the registry
July 25, 2023
CompletedFirst Posted
Study publicly available on registry
August 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2025
CompletedFebruary 10, 2026
February 1, 2026
1.6 years
July 25, 2023
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline to Week 6 in the AISRS total score
Adult ADHD Investigator Symptom Report Scale (AISRS)
6 weeks
Study Arms (3)
Solriamfetol 150 mg
EXPERIMENTALUp to 6 weeks
Solriamfetol 300 mg
EXPERIMENTALUp to 6 weeks
Placebo
PLACEBO COMPARATORUp to 6 weeks
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Clinical Research Site
Encino, California, 91316, United States
Clinical Research Site
Garden Grove, California, 92845, United States
Clinical Research Site
Newport Beach, California, 92660, United States
Clinical Research Site
Riverside, California, 92506, United States
Clinical Research Site
Santa Ana, California, 92705, United States
Clinical Research Site
Sherman Oaks, California, 91403, United States
Clinical Research Site
Torrance, California, 90504, United States
Clinical Research Site
Walnut Creek, California, 94596, United States
Clinical Research Site
Colorado Springs, Colorado, 80910, United States
Clinical Research Site
Clermont, Florida, 34711, United States
Clinical Research Site
Doral, Florida, 33122, United States
Clinical Research Site
Gainesville, Florida, 32607, United States
Clinical Research Site
Jacksonville, Florida, 32256, United States
Clinical Research Site
Lauderhill, Florida, 33319, United States
Clinical Research Site
Miami Lakes, Florida, 33016, United States
Clinical Research Site
Orlando, Florida, 32801, United States
Clinical Research Site
Marietta, Georgia, 30060, United States
Clinical Research Site
Overland Park, Kansas, 66210, United States
Clinical Research Site
Boston, Massachusetts, 02131, United States
Clinical Research Site
Saint Charles, Missouri, 63304, United States
Clinical Research Site
Lincoln, Nebraska, 68526, United States
Clinical Research Site
Las Vegas, Nevada, 89102, United States
Clinical Research Site
Las Vegas, Nevada, 89128, United States
Clinical Research Site
Berlin, New Jersey, 08009, United States
Clinical Research Site
Cherry Hill, New Jersey, 08002, United States
Clinical Research Site
Princeton, New Jersey, 08540, United States
Clinical Research Site
Mount Kisco, New York, 10549, United States
Clinical Research Site
New York, New York, 10128, United States
Clinical Research Site
Raleigh, North Carolina, 27609, United States
Clinical Research Site
Cincinnati, Ohio, 45219, United States
Clinical Research Site
Kettering, Ohio, 45439, United States
Clinical Research Site
Oklahoma City, Oklahoma, 73116, United States
Clinical Research Site
Media, Pennsylvania, 19063, United States
Clinical Research Site
North Charleston, South Carolina, 29405, United States
Clinical Research Site
Memphis, Tennessee, 38119, United States
Clinical Research Site
Austin, Texas, 78737, United States
Clinical Research Site
Bellaire, Texas, 77401, United States
Clinical Research Site
Dallas, Texas, 75243, United States
Clinical Research Site
Dallas, Texas, 75251, United States
Clinical Research Site
San Antonio, Texas, 78229, United States
Clinical Research Site
Draper, Utah, 84020, United States
Clinical Research Site
Everett, Washington, 98201, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2023
First Posted
August 2, 2023
Study Start
July 6, 2023
Primary Completion
February 7, 2025
Study Completion
March 14, 2025
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share