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

NCT07717879 · tracked via the Priya Life Science USA tracker

Sponsor

Axsome Therapeutics, Inc.

Phase

Phase 3

Started

2026-07-06

Last updated

2026-09-08

Condition(s) studied

ADHD

Investigational drug(s) / intervention(s)

Solriamfetol Dose A →Solriamfetol Dose B →Placebo

Solriamfetol Dose A: Solriamfetol capsules, taken once daily

Solriamfetol Dose B: Solriamfetol capsules, taken once daily

Placebo: Placebo capsules, taken once daily

Study 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.

Eligibility

Sex

ALL

Min age

6 Years

Max age

11 Years

Healthy volunteers

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.

Primary outcome measure(s)

ADHD-RS-5 Total Score, Change from Baseline to Week 6 — 6 weeks
Attention Deficit/ Hyperactivity Disorder Rating Scale-5, Interview with Informant, Child Version (ADHD-RS-5)

Trial sites (23)

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

More Axsome Therapeutics, Inc. trials in the USA

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A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder Enrolling by invitation

Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design Recruiting

Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-3) Recruiting

A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms Recruiting

Other trials for the same condition

A Study to Evaluate the Effects of a Supplement on the Side Effects Associated With Stimulant Medications Recruiting

tRNS Treatment for ADHD Symptoms Active, not recruiting

Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-3) Recruiting

An Adjunct Study to Assess Guided ADHD Therapy for Managing the Extent and Severity of Symptoms Active, not recruiting

EndeavorOTC™ Prospective Product Registry Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07717879 on ClinicalTrials.gov ↗ ← All trials in the USA