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Other

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
Must not have
Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription
Timeline
Screening 3 days
Treatment 6 weeks
Follow Up 6 weeks
Awards & highlights

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
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I have been diagnosed with ADHD.
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I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have previously taken solriamfetol/Sunosi.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for ADHD include stimulants like methylphenidate and amphetamines, and non-stimulants such as atomoxetine and guanfacine. Stimulants primarily work by increasing the levels of dopamine and norepinephrine in the brain, which helps improve attention and reduce impulsivity and hyperactivity. Non-stimulants like atomoxetine, a selective norepinephrine reuptake inhibitor, also increase norepinephrine levels but do so without the same stimulant effects. Solriamfetol, a dopamine and norepinephrine reuptake inhibitor (DNRI), similarly enhances the levels of these neurotransmitters. This is crucial for ADHD patients as it helps regulate attention, behavior, and executive function, thereby alleviating core symptoms of the disorder.
Lisdexamfetamine dimesylate in adults with attention-deficit/ hyperactivity disorder who report clinically significant impairment in executive function: results from a randomized, double-blind, placebo-controlled study.An update on the pharmacotherapy of attention-deficit/hyperactivity disorder in adults.

Find a Location

Who is running the clinical trial?

Axsome Therapeutics, Inc.Lead Sponsor
30 Previous Clinical Trials
9,957 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
~112 spots leftby Dec 2024