A Phase 3, Randomized, 6-Week, Double-blind, Placebo- Controlled Trial of Solriamfetol in Adolescents Aged 12 to <18 Years With Attention Deficit Hyperactivity Disorder (ADHD)
Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
Clinical Research Site
RECRUITING
Dothan
Arkansas
Clinical Research Site
RECRUITING
Little Rock
California
Clinical Research Site
RECRUITING
Irvine
Clinical Research Site
RECRUITING
Long Beach
Clinical Research Site
RECRUITING
Los Angeles
Clinical Research Site
RECRUITING
Walnut Creek
Florida
Clinical Research Site
RECRUITING
Coral Gables
Clinical Research Site
RECRUITING
Gainesville
Clinical Research Site
RECRUITING
Jacksonville
Clinical Research Site
RECRUITING
Maitland
Clinical Research Site
RECRUITING
Orlando
Georgia
Clinical Research Site
RECRUITING
Atlanta
Kentucky
Clinical Research Site
RECRUITING
Bardstown
Massachusetts
Clinical Research Site
RECRUITING
Springfield
Clinical Research Site
RECRUITING
Worcester
Mississippi
Clinical Research Site
RECRUITING
Jackson
Nevada
Clinical Research Site
RECRUITING
Las Vegas
New York
Clinical Research Site
RECRUITING
Staten Island
South Carolina
Clinical Research Site
RECRUITING
North Charleston
Tennessee
Clinical Research Site
RECRUITING
Memphis
Texas
Clinical Research Site
RECRUITING
Austin
Clinical Research Site
RECRUITING
Friendswood
Clinical Research Site
RECRUITING
San Antonio
Utah
Clinical Research Site
RECRUITING
Provo
Contact Information
Primary
Study Director
sol-adhd-304@axsome.com
212-332-5061
Time Frame
Start Date: 2026-06-25
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 468
Treatments
Experimental: Solriamfetol Dose A
Up to 6 weeks
Experimental: Solriamfetol Dose B
Up to 6 weeks
Placebo_comparator: Placebo
Up to weeks
Related Therapeutic Areas
Sponsors
Leads: Axsome Therapeutics, Inc.