Solriamfetol for Binge Eating Disorder

(ENGAGE Trial)

Recruiting at 40 trial locations

Overseen By Study Director

Age: 18 - 65

Sex: Any

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: 12 weeks

450 Participants Needed

Trial Summary

What is the purpose of this trial?

ENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of binge eating disorder (BED) in adults.

Do I need to stop my current medications to join the trial?

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.

What data supports the effectiveness of the drug solriamfetol for treating binge eating disorder?

The study protocol aims to evaluate solriamfetol, a drug that affects brain chemicals dopamine and norepinephrine, for its effectiveness in treating binge eating disorder. While direct data on solriamfetol for this condition is not provided, similar drugs like armodafinil have shown some promise in reducing binge eating episodes, suggesting potential benefits of solriamfetol. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults with binge eating disorder (BED). Participants must not have other conditions that could interfere with the study, such as bulimia or other significant psychiatric disorders. They should be able to follow the trial procedures and take medication as directed.

Inclusion Criteria

I have been diagnosed with Binge Eating Disorder.

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

I am between 18 and 55 years old.

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

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive solriamfetol (150 or 300 mg) or placebo once daily for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Solriamfetol

Trial Overview The ENGAGE trial is testing solriamfetol at two different doses (150 mg and 300 mg) against a placebo to see if it helps reduce binge eating episodes in adults. It's a Phase 3 study, meaning it's one of the final stages before potential approval for public use.

Participant Groups

Group I: Solriamfetol 300 mg Experimental Treatment 1 Intervention

Up to 12 weeks

Group II: Solriamfetol 150 mg Experimental Treatment 1 Intervention

Up to 12 weeks

Group III: Placebo Placebo Group 1 Intervention

Up to 12 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+

Findings from Research

This study is the first randomized, double-blind trial assessing the efficacy and safety of solriamfetol, a novel dopamine and norepinephrine reuptake inhibitor, in treating binge eating disorder (BED) over a 12-week period with 64 participants.

The primary outcome measured is the frequency of binge-eating days, which will help determine how effective solriamfetol is compared to a placebo in reducing binge eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol and rationale for a randomized, placebo-controlled trial of solriamfetol to treat binge eating disorder. Guerdjikova, AI., Romo-Nava, F., Blom, TJ., et al.[2021]

In a 10-week study involving 60 participants with binge eating disorder, armodafinil showed a significant reduction in binge eating episode frequency compared to placebo, although both groups had similar improvements in binge eating day frequency.

Armodafinil also led to significant reductions in obsessive-compulsive features and body mass index (BMI), with no serious adverse events reported, suggesting it may be a safe option for treating BED, though further research with larger samples is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Armodafinil in binge eating disorder: a randomized, placebo-controlled trial. McElroy, SL., Guerdjikova, AI., Mori, N., et al.[2022]

Pharmacotherapy has shown potential benefits for patients with binge eating disorder (BED), which involves episodes of uncontrollable eating without compensatory weight loss behaviors.

The paper reviews various medications and their effectiveness in treating BED, highlighting the need for further research to optimize pharmacological treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological management of binge eating disorder: current and emerging treatment options. McElroy, SL., Guerdjikova, AI., Mori, N., et al.[2021]

A review of pharmacologic trials for binge eating disorder (BED) found that several medications, including antidepressants like fluoxetine and sertraline, as well as appetite suppressants and anticonvulsants, are effective in treating BED.

The study supports the use of these medications based on placebo-controlled trials, providing guidelines for their pharmacologic management in patients with BED.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacologic treatment of binge eating disorder. Carter, WP., Hudson, JI., Lalonde, JK., et al.[2022]

Binge-eating disorder (BED) is the most common eating disorder among Black women, with contributing factors such as stress, trauma, and food insecurity identified as significant.

Despite the availability of evidence-based treatments for BED, Black women face disparities in access to care and treatment retention, highlighting the need for culturally relevant assessments and collaborative care approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Binge-Eating Disorder in Black Women: Treatment Recommendations and Implications for Healthcare Providers. Goode, RW., Webster, CK., Gwira, RE.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Study protocol and rationale for a randomized, placebo-controlled trial of solriamfetol to treat binge eating disorder. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Armodafinil in binge eating disorder: a randomized, placebo-controlled trial. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacological management of binge eating disorder: current and emerging treatment options. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Pharmacologic treatment of binge eating disorder. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A Review of Binge-Eating Disorder in Black Women: Treatment Recommendations and Implications for Healthcare Providers. [2023]