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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

Study Summary

This trial tests the effectiveness of a new medication for ADHD in adults. Neither the participants nor the researchers will know who is taking the medication or the placebo.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
A Priori Definition of Clinical Improvement
Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score
Secondary outcome measures
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
2,928 Previous Clinical Trials
13,198,289 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)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are adults aged 35 and up being sought for this experiment?

"The age range for this study is from 18 to 65 years old."

Answered by AI

How many participants are expected to enroll in this research project?

"That is correct, according to the information available on clinicaltrials.gov. The trial in question was first posted on 8/6/2021 and is currently seeking 60 patients from 1 location."

Answered by AI

Is this research project still welcoming participants?

"Yes, that is correct. As the data on clinicaltrials.gov show, this trial was posted on 8/6/2021 and is actively recruiting patients. The study needs to recruit 60 patients from 1 site."

Answered by AI

What are the most recent clinical studies completed on Solriamfetol 75 MG?

"Currently, there are 3 ongoing clinical trials for Solriamfetol 75 MG. 1 of these trials is in Phase 3 while the other 2 are still in earlier phases. The majority of these medical studies are taking place in Boston, but you can find them occurring in a total of 3 different locations."

Answered by AI

What other similar research projects exist?

"Research for Solriamfetol 75 MG began in 2021 with a study sponsored by Jazz Pharmaceuticals. The first Phase 4 clinical trial was conducted the same year and involved 64 patients. Currently, there are 3 active studies being performed in 2 cities and 1 country."

Answered by AI

Might I be eligible to join this clinical research?

"This clinical study is looking for 60 participants that suffer from attention deficit disorder and meet the following inclusion criteria: A score of 20 or more on the Adult ADHD Investigator Symptom Report Scale (AISRS), Adults ages 18-65 years of age., A diagnosis of childhood-onset ADHD, meeting the Diagnostic and Statistcal Manual-5 (DSM-5) criteria for ADHD in adulthood, including at least 5 current symptoms of inattentive or impulsive-hyperactive traits, and childhood onset by age 12, defined as two symptoms of inattentive or of impulsive/hyperactive traits by the"

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
Pennsylvania
Massachusetts
Other
How old are they?
< 18
18 - 65
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
3+

Why did patients apply to this trial?

Seeking new treatment. Because I'm tired of the lack or research and education in woman/girls with ADHD. We can do better.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Phone Call
Average response time
  • < 2 Days
Most responsive sites:
  1. Massachusetts General Hospital: < 24 hours
Recent research and studies
clinicaltrials.govStudy
A Controlled Study of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD) in Adults
Craig B. Surman, MD 2021. "A Controlled Study of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD) in Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04839562.
~18 spots leftby Apr 2025
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