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Central Nervous System Stimulant

Solriamfetol 75 MG for Attention Deficit Hyperactivity Disorder (ADHD)

Phase 2 & 3
Waitlist Available
Led By Craig Surman, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Summary

This trial is testing solriamfetol, a medication that helps improve wakefulness, in adults with ADHD. The medication works by increasing certain chemicals in the brain that help with attention and focus. Participants will be those who have significant ADHD symptoms.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and six weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
A Priori Definition of Clinical Improvement
Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score
Secondary study objectives
Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Behavioral Regulation Index
Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Emotional Control Subscale
Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Global Executive Composite Index
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: solriamfetolExperimental Treatment2 Interventions
Participant will receive daily doses of solriamfetol, at 75 mg at week one and 150 mg at week 2, and with intention that dosing remain stable for the last four weeks of study participation, such that investigators will ask a subject to go back down to 75 mg during any of the weeks following week 2 only if only if 150 mg is not tolerated.
Group II: placeboPlacebo Group1 Intervention
Participant will receive daily doses of placebo, at 75 mg at week one and 150 mg at week 2, and with intention that dosing remain stable for the last four weeks of study participation, such that investigators will ask a subject to go back down to 75 mg during any of the weeks following week 2 only if only if 150 mg is not tolerated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Solriamfetol 75 MG
2021
Completed Phase 3
~70
Solriamfetol 150 MG
2021
Completed Phase 3
~70

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,993 Previous Clinical Trials
13,230,655 Total Patients Enrolled
59 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
8,473 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Craig Surman, MDPrincipal InvestigatorMass General Brigham
6 Previous Clinical Trials
221 Total Patients Enrolled
6 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
221 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
~16 spots leftby Sep 2025
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