What side effects are associated with this type of intervention?

Common treatments for ADHD, such as stimulants (e.g., amphetamines and methylphenidate) and non-stimulants (e.g., atomoxetine), often have side effects including insomnia, decreased appetite, weight loss, increased heart rate, and elevated blood pressure. Solriamfetol, a Dopamine and Norepinephrine Reuptake Inhibitor, shares some of these side effects, particularly insomnia and increased heart rate. Other potential side effects of Solriamfetol include headache, nausea, and anxiety. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of ADHD, including stimulants like methylphenidate and amphetamines, which are the most commonly prescribed. These drugs work by increasing the levels of dopamine and norepinephrine in the brain. Non-stimulant medications such as atomoxetine, a selective norepinephrine reuptake inhibitor, and guanfacine, an alpha-2A adrenergic receptor agonist, have also been approved. Solriamfetol, a DNRI, is currently being studied for its efficacy and safety in treating ADHD, similar to its approved use for excessive daytime sleepiness in narcolepsy.

What other types of research exist?

Promising novel alternatives to Solriamfetol for ADHD treatment include: 1) Osmotic Release Oral System Methylphenidate (OROS-MPH), which has shown efficacy in poor adherents to immediate-release methylphenidate. 2) NWP06, an extended-release oral suspension of methylphenidate, which improved ADHD symptoms in a laboratory classroom study. 3) SHP465 mixed amphetamine salts, which demonstrated efficacy, safety, and tolerability in children and adolescents with ADHD in a randomized, double-blind, placebo-controlled study.

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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

Pivotal Trial

Summary

This trial is testing solriamfetol, a medication that may help adults with ADHD by balancing brain chemicals that control focus and activity levels. Participants will take solriamfetol once daily for several weeks to see if it improves their symptoms. Solriamfetol has been studied for its effectiveness in treating excessive sleepiness related to narcolepsy and obstructive sleep apnea, showing improvements in sleep latency and overall sleepiness scores.

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.

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.

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:

Select...

I have previously taken solriamfetol/Sunosi.

Timeline

Screening ~ 3 days1 visit

Treatment ~ 6 weeks0 visits

Follow Up ~ 6 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline to Week 6 in the AISRS total score

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 3Eligibility criteria met

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.