Solriamfetol for ADHD

Recruiting at 44 trial locations

Overseen By Study Director

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 3

Sponsor: Axsome Therapeutics, Inc.

Disqualifiers: Prior solriamfetol exposure, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

516 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive solriamfetol 150 mg, solriamfetol 300 mg, or placebo once daily for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Solriamfetol

Trial Overview 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.

Participant Groups

Group I: Solriamfetol 300 mg Experimental Treatment 1 Intervention

Up to 6 weeks

Group II: Solriamfetol 150 mg Experimental Treatment 1 Intervention

Up to 6 weeks

Group III: Placebo Placebo Group 1 Intervention

Up to 6 weeks

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

Approved in United States as Sunosi for:

• Excessive daytime sleepiness in patients with narcolepsy
• Excessive daytime sleepiness in patients with obstructive sleep apnea

Who Is Running the Clinical Trial?

Axsome Therapeutics, Inc.

Lead Sponsor

Trials

34

Recruited

11,600+