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Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)

RecruitingPhase 3

Sponsor: Axsome Therapeutics, Inc.

Conditions: ADHD

Interventions: Solriamfetol Dose A, Solriamfetol Dose B, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 6 Years to 11 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (23)

Dothan, Alabama, United States
Little Rock, Arkansas, United States
Irvine, California, United States
Long Beach, California, United States
Orange, California, United States
Walnut Creek, California, United States
Coral Gables, Florida, United States
Jacksonville, Florida, United States
Maitland, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Bardstown, Kentucky, United States
Springfield, Massachusetts, United States
Worcester, Massachusetts, United States
Jackson, Mississippi, United States
Las Vegas, Nevada, United States
Staten Island, New York, United States
North Charleston, South Carolina, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Friendswood, Texas, United States
San Antonio, Texas, United States
Provo, Utah, United States