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.
Eligible subjects are children, 6 to \<12 years of age, with a primary diagnosis of ADHD based on criteria established by the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol dose A, solriamfetol dose B or placebo once daily for 6 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
468
Solriamfetol capsules, taken once daily
Solriamfetol capsules, taken once daily
Placebo capsules, taken once daily
Clinical Research Site
Dothan, Alabama, United States
ADHD-RS-5 Total Score, Change from Baseline to Week 6
Attention Deficit/ Hyperactivity Disorder Rating Scale-5, Interview with Informant, Child Version (ADHD-RS-5)
Time frame: 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinical Research Site
Little Rock, Arkansas, United States
RECRUITINGClinical Research Site
Irvine, California, United States
RECRUITINGClinical Research Site
Long Beach, California, United States
RECRUITINGClinical Research Site
Orange, California, United States
RECRUITINGClinical Research Site
Walnut Creek, California, United States
RECRUITINGClinical Research Site
Coral Gables, Florida, United States
RECRUITINGClinical Research Site
Jacksonville, Florida, United States
RECRUITINGClinical Research Site
Maitland, Florida, United States
RECRUITINGClinical Research Site
Orlando, Florida, United States
RECRUITING...and 13 more locations