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Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
Sponsor: Axsome Therapeutics, Inc.
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 children aged 6 to \<12 years with ADHD.
Official title: A Phase 3, Randomized, 6-Week, Double-blind, Placebo-controlled Trial of Solriamfetol in Children Aged 6 to <12 Years With Attention Deficit Hyperactivity Disorder (ADHD)
Key Details
Gender
All
Age Range
6 Years - 11 Years
Study Type
INTERVENTIONAL
Enrollment
468
Start Date
2026-07-06
Completion Date
2028-06-30
Last Updated
2026-09-08
Healthy Volunteers
No
Conditions
Interventions
Solriamfetol Dose A
Solriamfetol capsules, taken once daily
Solriamfetol Dose B
Solriamfetol capsules, taken once daily
Placebo
Placebo capsules, taken once daily
Locations (23)
Clinical Research Site
Dothan, Alabama, United States
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Little Rock, Arkansas, United States
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Irvine, California, United States
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Long Beach, California, United States
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Orange, California, United States
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Walnut Creek, California, United States
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Coral Gables, Florida, United States
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Jacksonville, Florida, United States
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Maitland, Florida, United States
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Orlando, Florida, United States
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Atlanta, Georgia, United States
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Bardstown, Kentucky, United States
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Springfield, Massachusetts, United States
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Worcester, Massachusetts, United States
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Jackson, Mississippi, United States
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Las Vegas, Nevada, United States
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Staten Island, New York, United States
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North Charleston, South Carolina, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Friendswood, Texas, United States
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San Antonio, Texas, United States
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Provo, Utah, United States