Solriamfetol for ADHD
Recruiting at 44 trial locations
SD
SD
Overseen ByStudy Director
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
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.
Treatment Details
Interventions
- Solriamfetol (Other)
Trial OverviewThe 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
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Axsome Therapeutics, Inc.
Lead Sponsor
Trials
34
Recruited
11,600+