Recruiting
Phase 3

Solriamfetol

Sponsor:

Axsome Therapeutics, Inc.

Code:

NCT07717879

Conditions

ADHD

Eligibility Criteria

Sex: All

Age: 6 - 11

Healthy Volunteers: Not accepted

Interventions

Solriamfetol Dose A

Solriamfetol Dose B

Placebo

Study Details

Brief 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.

Conditions

ADHD

Study ID

NCT07717879

Start date

Jul 6, 2026

Status verified date

Sep, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 11

Healthy Volunteers: Not accepted

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

Enrollment

468 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Solriamfetol Dose A

Up to 6 weeks

experimental: Solriamfetol Dose B

Up to 6 weeks

placebo comparator: Placebo

Up to 6 weeks

Interventions

Solriamfetol Dose A

Solriamfetol capsules, taken once daily

Solriamfetol Dose B

Solriamfetol capsules, taken once daily

Placebo

Placebo capsules, taken once daily

Primary outcome measure

  • ADHD-RS-5 Total Score, Change from Baseline to Week 6 [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Study Director

212-332-5061sol-adhd-302@axsome.com

Locations

Clinical Research Site

Recruiting

Dothan, Alabama, United States, 36303

Clinical Research Site

Recruiting

Little Rock, Arkansas, United States, 72211

Clinical Research Site

Recruiting

Irvine, California, United States, 92604

Clinical Research Site

Recruiting

Long Beach, California, United States, 90806

Clinical Research Site

Recruiting

Orange, California, United States, 92868

Clinical Research Site

Recruiting

Walnut Creek, California, United States, 94596

Clinical Research Site

Recruiting

Coral Gables, Florida, United States, 33146

Clinical Research Site

Recruiting

Jacksonville, Florida, United States, 32256

Clinical Research Site

Recruiting

Maitland, Florida, United States, 32751

Clinical Research Site

Recruiting

Orlando, Florida, United States, 32801

Clinical Research Site

Recruiting

Atlanta, Georgia, United States, 30318

Clinical Research Site

Recruiting

Bardstown, Kentucky, United States, 40004

Clinical Research Site

Recruiting

Springfield, Massachusetts, United States, 01103

Clinical Research Site

Recruiting

Worcester, Massachusetts, United States, 01608

Clinical Research Site

Recruiting

Jackson, Mississippi, United States, 39206

Clinical Research Site

Recruiting

Las Vegas, Nevada, United States, 89128

Clinical Research Site

Recruiting

Staten Island, New York, United States, 10314

Clinical Research Site

Recruiting

North Charleston, South Carolina, United States, 29405

Clinical Research Site

Recruiting

Memphis, Tennessee, United States, 38119

Clinical Research Site

Recruiting

Austin, Texas, United States, 78759

Clinical Research Site

Recruiting

Friendswood, Texas, United States, 77546

Clinical Research Site

Recruiting

San Antonio, Texas, United States, 78229

Clinical Research Site

Recruiting

Provo, Utah, United States, 84604

More Information

Sponsor

Axsome Therapeutics, Inc.

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Attention deficit hyperactivity disorder
  • ADHD
  • Sunosi
  • Solriamfetol
  • Axsome
  • Non-stimulant therapy
  • Dopamine norepinephrine reuptake inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-14. This information was provided to ClinicalTrials.gov by Axsome Therapeutics, Inc. on 2026-09-08.