468 Participants NeededMy employer runs this trial

Solriamfetol for ADHD

Recruiting at 9 trial locations
Age: < 18
Sex: Any
Trial Phase: Phase 3
Sponsor: Axsome Therapeutics, Inc.
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
1 Power Preferred Clinic1 of this trial's clinic is considered top 20 on Power

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for children aged 6 to under 12 years who have been diagnosed with ADHD. Participants should generally be in good health aside from their ADHD.

Inclusion Criteria

Are you the child’s parent or legal guardian, and can you give permission for them to join?
Is your child 6 to 11 years old?
Can your child follow the study instructions and say yes to joining the study?

Exclusion Criteria

Does your child have a health problem that may prevent them from joining the study?

What Are the Treatments Tested in This Trial?

Interventions

  • Solriamfetol

Trial Overview

The study is testing two different doses of solriamfetol compared to a placebo (inactive pill) over six weeks. Children are randomly assigned to one of the groups, and neither they nor the researchers know which treatment they're getting.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Solriamfetol Dose BExperimental Treatment1 Intervention
Group II: Solriamfetol Dose AExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Axsome Therapeutics, Inc.

Lead Sponsor

Trials
34
Recruited
11,600+