Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-3)
Recruiting · NCT07717892 · Interventional (participants receive a specific treatment) · Lead sponsor: Axsome Therapeutics, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboSolriamfetol Dose ASolriamfetol Dose B
What this trial is about
This study is a Phase 3, multi-center, randomized, 6-week, double-blind, placebo-controlled, parallel-group trial to assess the efficacy and safety of solriamfetol in adolescents aged 12 to \<18 years with ADHD.
Who can take part
Age range
12 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Male or female, aged 12 to \<18 years.
- Primary diagnosis of ADHD according to DSM-5 criteria.
- Has parents/legal guardians provide written informed consent and has child provide written informed assent to participate in the study before the conduct of any study procedures.
Exclusion criteria
- Unable to comply with study procedures.
- Medically inappropriate for study participation in the opinion of the investigator.
Where it is running
24 locations listed across 14 US states.
- Clinical Research Site - Dothan, Alabama, United States
- Clinical Research Site - Little Rock, Arkansas, United States
- Clinical Research Site - Irvine, California, United States
- Clinical Research Site - Long Beach, California, United States
- Clinical Research Site - Los Angeles, California, United States
- Clinical Research Site - Walnut Creek, California, United States
- Clinical Research Site - Coral Gables, Florida, United States
- Clinical Research Site - Gainesville, Florida, United States
- Clinical Research Site - Jacksonville, Florida, United States
- Clinical Research Site - Maitland, Florida, United States
- Clinical Research Site - Orlando, Florida, United States
- Clinical Research Site - Atlanta, Georgia, United States
- Clinical Research Site - Bardstown, Kentucky, United States
- Clinical Research Site - Springfield, Massachusetts, United States
- Clinical Research Site - Worcester, Massachusetts, United States
- Clinical Research Site - Jackson, Mississippi, United States
- Clinical Research Site - Las Vegas, Nevada, United States
- Clinical Research Site - Staten Island, New York, United States
- Clinical Research Site - North Charleston, South Carolina, United States
- Clinical Research Site - Memphis, Tennessee, United States
- Clinical Research Site - Austin, Texas, United States
- Clinical Research Site - Friendswood, Texas, United States
- Clinical Research Site - San Antonio, Texas, United States
- Clinical Research Site - Provo, Utah, United States