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Solriamfetol for ADHD

Phase 3
Recruiting
Research Sponsored by Axsome Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary diagnosis of ADHD according to DSM-5 criteria
Male or female, aged 18 to 55 inclusive
Timeline
Screening 3 days
Treatment 6 weeks
Follow Up 6 weeks
Awards & highlights

Study Summary

This trial tests if a drug is safe & effective for adults with ADHD. Results will show if it can help them concentrate & stay focused.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects of Solriamfetol may include trouble sleeping, headaches, decreased appetite, dry mouth, nausea, anxiety, dizziness, increased heart rate or blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with ADHD.
Select...
I am between 18 and 55 years old.

Timeline

Screening ~ 3 days
Treatment ~ 6 weeks
Follow Up ~6 weeks
This trial's timeline: 3 days for screening, 6 weeks for treatment, and 6 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
Change from Baseline to Week 6 in the AISRS total score

Trial Design

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 Location

Who is running the clinical trial?

Axsome Therapeutics, Inc.Lead Sponsor
28 Previous Clinical Trials
7,742 Total Patients Enrolled

Media Library

Solriamfetol (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05972044 — Phase 3
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Placebo, Solriamfetol 300 mg, Solriamfetol 150 mg
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Solriamfetol Highlights & Side Effects. Trial Name: NCT05972044 — Phase 3
Solriamfetol (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05972044 — Phase 3

Frequently Asked Questions

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

Is the study age-restricted, or can those 25 and above partake in the research?

"This clinical trial requires that all participants are over the age of 18 and under 55 years old."

Answered by AI

Are there any risks associated with Solriamfetol 150 mg dosage?

"Our team has assigned a score of 3 to Solriamfetol 150 mg due to the presence of prior clinical data indicating its efficacy and safety."

Answered by AI

Are there specific demographics that are most appropriate for this research endeavor?

"The primary inclusion criteria for this research is a documented diagnosis of ADHD and ages 18 to 55. Approximately 450 volunteers are still needed for the trial."

Answered by AI

Are there any available openings in this clinical trial for participants?

"As per data hosted on clinicaltrials.gov, this study is presently seeking research participants. It was first posted to the site on July 6th 2023 and recently modified on July 25th of that same year."

Answered by AI

What is the geographic scope of this trial’s implementation?

"Presently, the study is running operations in five sites located near Cherry Hill, Memphis and San Antonio amongst other cities. To reduce transportation burdens associated with participating, it may be best to select a site closest to your own residence."

Answered by AI

How many individuals are currently being observed for this research?

"Affirmative. Clinicaltrials.gov attests to this trial's current recruitment status, which began on July 6th 2023 and was last modified on the 25th of that same month. This research is focused on obtaining 450 participants at 5 different locations."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
What site did they apply to?
Clinical Research Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0

What questions have other patients asked about this trial?

How long will this trial last? Will I have to stop taking my prescribed Concerta throughout?
PatientReceived no prior treatments

Why did patients apply to this trial?

Th hopefully help science out. Looking for additional help with adhd. I wanted to get a better treatment for my ADHD.
PatientReceived 1 prior treatment
I’ve tried other adhd medications and they haven’t worked.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. Clinical Research Site: < 24 hours
Recent research and studies
clinicaltrials.govStudy
A Study to Access the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)
2023. "A Study to Access the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05972044.
All > Paid Studies Las Vegas > Adhd
~197 spots leftby Dec 2024
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