A Controlled Study of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD) in Adults

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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ six weeks

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