Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
Purpose
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.
Condition
- ADHD
Eligibility
- Eligible Ages
- Between 6 Years and 11 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male or female, aged 6 to <12 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Solriamfetol Dose A |
Up to 6 weeks |
|
|
Experimental Solriamfetol Dose B |
Up to 6 weeks |
|
|
Placebo Comparator Placebo |
Up to 6 weeks |
|
Recruiting Locations
Clinical Research Site
Dothan, Alabama 36303
Dothan, Alabama 36303
Clinical Research Site
Little Rock, Arkansas 72211
Little Rock, Arkansas 72211
Clinical Research Site
Irvine, California 92604
Irvine, California 92604
Clinical Research Site
Long Beach, California 90806
Long Beach, California 90806
Clinical Research Site
Orange, California 92868
Orange, California 92868
Clinical Research Site
Walnut Creek, California 94596
Walnut Creek, California 94596
Clinical Research Site
Coral Gables, Florida 33146
Coral Gables, Florida 33146
Clinical Research Site
Jacksonville, Florida 32256
Jacksonville, Florida 32256
Clinical Research Site
Maitland, Florida 32751
Maitland, Florida 32751
Clinical Research Site
Orlando, Florida 32801
Orlando, Florida 32801
Clinical Research Site
Atlanta, Georgia 30318
Atlanta, Georgia 30318
Clinical Research Site
Bardstown, Kentucky 40004
Bardstown, Kentucky 40004
Clinical Research Site
Springfield, Massachusetts 01103
Springfield, Massachusetts 01103
Clinical Research Site
Worcester, Massachusetts 01608
Worcester, Massachusetts 01608
Clinical Research Site
Jackson, Mississippi 39206
Jackson, Mississippi 39206
Clinical Research Site
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Clinical Research Site
Staten Island, New York 10314
Staten Island, New York 10314
Clinical Research Site
North Charleston, South Carolina 29405
North Charleston, South Carolina 29405
Clinical Research Site
Memphis, Tennessee 38119
Memphis, Tennessee 38119
Clinical Research Site
Austin, Texas 78759
Austin, Texas 78759
Clinical Research Site
Friendswood, Texas 77546
Friendswood, Texas 77546
Clinical Research Site
San Antonio, Texas 78229
San Antonio, Texas 78229
Clinical Research Site
Provo, Utah 84604
Provo, Utah 84604
More Details
- Status
- Recruiting
- Sponsor
- Axsome Therapeutics, Inc.
Detailed Description
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.