Solriamfetol for ADHD

No longer recruiting at 44 trial locations

Overseen By Study Director

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 3

Sponsor: Axsome Therapeutics, Inc.

Disqualifiers: Prior solriamfetol exposure, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of solriamfetol for treating adults with ADHD. Participants will receive either solriamfetol or a placebo (a substance with no active drug) for up to six weeks. The goal is to determine if solriamfetol can reduce ADHD symptoms such as inattention and hyperactivity. Ideal candidates for this trial are those diagnosed with ADHD who have not previously used solriamfetol and can adhere to study procedures. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new ADHD treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that solriamfetol is generally well-tolerated in clinical studies. Previous research on sleep disorders found it to be safe, providing doctors with a good understanding of its safety profile.

In real-world studies, about 33% of patients experienced some side effects, with headaches and reduced appetite being the most common. Some individuals also reported anxiety, trouble sleeping, or irritability.

These results come from studies where solriamfetol was used for various conditions, not just ADHD, which enhances its safety assurance. However, individual experiences with any treatment can vary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ADHD?

Unlike the standard ADHD treatments that primarily involve stimulants like amphetamines or methylphenidate, Solriamfetol offers a different approach. This medication works by targeting both dopamine and norepinephrine transporters, which may enhance focus and attention without the typical stimulant side effects. Researchers are particularly excited about Solriamfetol because it has shown potential for fast-acting benefits, possibly improving symptoms in just a few days compared to the weeks that some current treatments require. Additionally, its dual mechanism might provide a novel option for individuals who don't respond well to existing medications.

What evidence suggests that solriamfetol might be an effective treatment for ADHD?

Research has shown that solriamfetol can help reduce ADHD symptoms in adults. One study found it reduced average ADHD symptoms by almost half. Participants in that trial received solriamfetol at either 150 mg or 300 mg doses and showed noticeable improvements in their overall ADHD condition compared to those who took a placebo. Improvements in symptoms appeared by the third week and continued through the sixth week of treatment. These results suggest that solriamfetol could be a promising treatment option for adults with ADHD. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Provides written informed consent to participate in the study before the conduct of any study procedures

I have been diagnosed with ADHD.

Exclusion Criteria

Unable to comply with study procedures

Medically inappropriate for study participation in the opinion of the investigator

I have previously taken solriamfetol/Sunosi.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive solriamfetol 150 mg, solriamfetol 300 mg, or placebo once daily for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Solriamfetol

Trial Overview 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.

How Is the Trial Designed?

Group I: Solriamfetol 300 mg Experimental Treatment 1 Intervention

Up to 6 weeks

Group II: Solriamfetol 150 mg Experimental Treatment 1 Intervention

Up to 6 weeks

Group III: Placebo Placebo Group 1 Intervention

Up to 6 weeks

Solriamfetol is already approved in United States for the following indications:

Approved in United States as Sunosi for:

• Excessive daytime sleepiness in patients with narcolepsy
• Excessive daytime sleepiness in patients with obstructive sleep apnea

Who Is Running the Clinical Trial?

Axsome Therapeutics, Inc.

Lead Sponsor

Trials

34

Recruited

11,600+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37819836/

Solriamfetol for Attention-Deficit/Hyperactivity Disorder in ... Compared to individuals on placebo, individuals on solriamfetol treatment experienced adverse events at a rate of at least 10 percentage points ...

2. psychiatrictimes.com psychiatrictimes.com/view/phase-3-trial-success-solriamfetol-for-the-treatment-of-adults-with-adhd

Solriamfetol for the Treatment of Adults With ADHD The results of the FOCUS trial demonstrate that solriamfetol was able to reduce mean ADHD symptom burden by nearly 50%, which contributed to ...

3. axsometherapeuticsinc.gcs-web.com axsometherapeuticsinc.gcs-web.com/node/11946/pdf

Axsome Therapeutics Announces FOCUS Phase 3 Trial of ... The study also achieved the key secondary endpoint by statistically significantly reducing overall ADHD disease severity compared to placebo, as.

4. empr.com empr.com/news/solriamfetol-significantly-reduces-adhd-symptoms-in-phase-3-trial/

Solriamfetol Significantly Reduces ADHD Symptoms in ... “The results of the FOCUS trial demonstrate that solriamfetol was able to reduce mean ADHD symptom burden by nearly fifty percent, which ...

5. mghpsychnews.org mghpsychnews.org/solriamfetol-sunosi-another-option-for-adhd/

Another Option for the Treatment of Adult ADHD? Individuals treated with solriamfetol noted greater improvements in total AISRS scores by week 3 through week 6 (P = .0012; week 6 effect size = ...

6. ema.europa.eu ema.europa.eu/en/documents/rmp/sunosi-epar-risk-management-plan_en.pdf

Sunosi, INN-solriamfetol - EMA There is a substantial amount of evidence that there are no differences in the disease pathophysiology and core symptoms as well as co-morbidities and treatment ...

7. sunosi.com sunosi.com/pi/sunosi.en.USPI.pdf

Prescribing Information 5.2 Psychiatric Symptoms. Psychiatric adverse reactions have been observed in clinical trials with SUNOSI, including anxiety, insomnia, and irritability [see ...

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/62/NCT04839562/Prot_SAP_000.pdf

Solriamfetol for ADHD in Adults Prior clinical data to support efficacy in sleep disorder indications, and the product's well- elaborated safety profile, also suggest potential favorable ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11868153/

SURWEY real-world study of solriamfetol: initiation, titration ... A total of 27 patients (33%) reported an adverse event. The most frequent adverse events were headache (9%), decreased appetite (7%), and ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024144817

Post-marketing safety profile of solriamfetol: A real-world ... Several clinical trials have confirmed solriamfetol's safety and effectiveness, collectively highlight its good therapeutic effect in patients ...