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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness and safety of solriamfetol for treating binge eating disorder (BED) in adults. Researchers will compare solriamfetol, administered in two different doses, to a placebo (a pill with no active drug) over 12 weeks. The trial aims to determine if solriamfetol can reduce the urge to binge eat by affecting certain brain chemicals. Adults diagnosed with BED who have not previously tried solriamfetol may be suitable candidates. 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 treatment.

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.

Is there any evidence suggesting that solriamfetol is likely to be safe for humans?

Research has shown that solriamfetol has been tested in other studies without major safety issues. One study on conditions like narcolepsy and sleep apnea reported no significant safety concerns, with main side effects occurring only at high doses.

The FDA has already approved solriamfetol for other uses, indicating its general safety. However, side effects can vary among individuals. This information may help prospective trial participants feel more informed about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for binge eating disorder?

Researchers are excited about solriamfetol for binge eating disorder because it offers a novel approach compared to existing treatments like cognitive behavioral therapy and medications such as lisdexamfetamine. Solriamfetol primarily works as a dopamine and norepinephrine reuptake inhibitor, which is different from the mechanisms of other medications that target neurotransmitter systems differently. This unique action could potentially lead to improved focus and reduced urges to binge eat. Additionally, solriamfetol's existing approval for sleep disorders suggests it could be a well-tolerated option with a known safety profile.

What evidence suggests that solriamfetol might be an effective treatment for binge eating disorder?

Research has shown that solriamfetol, a drug affecting certain brain chemicals, might help with binge eating disorder (BED). Studies indicate that solriamfetol often reduces appetite and can lead to weight loss. In a 40-week study, 32.4% of participants lost a significant amount of weight. This trial tests solriamfetol in different dosages to determine if it can manage binge-eating episodes by altering brain chemistry, potentially controlling the urge to binge eat. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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

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 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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714421003232

Study protocol and rationale for a randomized, placebo ... In the long-term (40-week) open-label trial, which combined narcolepsy and OSA patients, rates of ≥5% weight loss were 4.5%, 17.3%, and 32.4% for maintenance ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04602936

NCT04602936 | Solriamfetol in Binge Eating Disorder The goal of this project is to evaluate the efficacy and tolerability of the novel dopamine and norepinephrine reuptake inhibitor (DNRI) solriamfetol in the ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34610482/

Study protocol and rationale for a randomized, placebo ... The primary outcome is binge-eating day frequency as assessed by take-home patient-completed binge eating diaries.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1389945722011005

Effects of solriamfetol treatment on body weight in ... Solriamfetol commonly is associated with decreased appetite. After ≤52 weeks solriamfetol, overall median weight change was −1.76% from baseline.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06413433

Study Details | NCT06413433 | Elucidating TAAR-1, ... ENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled ...

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

Sunosi, INN-solriamfetol - EMA No significant safety concerns for the clinical use of solriamfetol arose from toxicology studies. The principal toxicities noted at high doses of solriamfetol ...