Solriamfetol for ADHD

Recruiting in Palo Alto (17 mi)

+37 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Axsome Therapeutics, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?This trial is testing solriamfetol, a medication that may help adults with ADHD by balancing brain chemicals that control focus and activity levels. Participants will take solriamfetol once daily for several weeks to see if it improves their symptoms. Solriamfetol has been studied for its effectiveness in treating excessive sleepiness related to narcolepsy and obstructive sleep apnea, showing improvements in sleep latency and overall sleepiness scores.

Eligibility Criteria

This trial is for adults aged 18 to 55 who have been diagnosed with ADHD according to DSM-5 criteria. Participants must be able to follow the study procedures and give written consent. Those who've previously used Solriamfetol/Sunosi or are deemed medically unfit by the investigator cannot join.

Inclusion Criteria

I am between 18 and 55 years old.

Provides written informed consent to participate in the study before the conduct of any study procedures

I have been diagnosed with ADHD.

Exclusion Criteria

Unable to comply with study procedures

Medically inappropriate for study participation in the opinion of the investigator

I have previously taken solriamfetol/Sunosi.

Participant Groups

The FOCUS trial is testing the effectiveness and safety of a drug called Solriamfetol in two different doses (150 mg and 300 mg) compared to a placebo, which has no active ingredients. This study randomly assigns participants into groups without them knowing which treatment they're getting.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Solriamfetol 300 mgExperimental Treatment1 Intervention

Up to 6 weeks

Group II: Solriamfetol 150 mgExperimental Treatment1 Intervention

Up to 6 weeks

Group III: PlaceboPlacebo Group1 Intervention

Up to 6 weeks

Solriamfetol is already approved in United States for the following indications:

🇺🇸 Approved in United States as Sunosi for: