Solriamfetol for Binge Eating Disorder

Enrolling by invitation at 28 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Axsome Therapeutics, Inc.

Disqualifiers: Significant change in vital signs, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines solriamfetol to determine its safety and effectiveness in treating binge eating disorder (BED) in adults. BED involves consuming large amounts of food quickly while feeling a loss of control. The trial lasts up to 52 weeks and is open to those who completed a previous study on this treatment. It aims to assist individuals struggling with frequent binge eating episodes. Participants must have completed the earlier study and be able to adhere to the study rules. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment for BED.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if there has been a significant change in your medications since the previous study, it might affect your eligibility.

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

Research has shown that solriamfetol is generally safe and well-tolerated. One study tested it on individuals with conditions like binge eating disorder and excessive sleepiness. The results indicated that solriamfetol was safe, with manageable side effects. Although specific side effects were not listed, the overall findings suggest it was well-tolerated by participants.

This trial is in a late stage, building on earlier research to assess the long-term safety of solriamfetol. When a treatment reaches this stage, earlier studies typically have not revealed major safety concerns. Solriamfetol is already approved for other conditions, suggesting it has been found safe for human use. ^{1 2 3 4 5}

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

Solriamfetol is unique because it offers a novel approach to treating binge eating disorder. Unlike traditional treatments that primarily target neurotransmitters like serotonin, Solriamfetol works by enhancing the activity of dopamine and norepinephrine, which are key players in mood and impulse control. This distinct mechanism could potentially offer quicker and more effective relief from binge eating episodes. Researchers are excited about Solriamfetol because it could provide an alternative for those who haven't found success with current options like cognitive behavioral therapy or medications such as SSRIs.

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

Research shows that solriamfetol, a drug affecting certain brain chemicals, is under study in this trial for its potential to help people with binge eating disorder (BED). Earlier studies have shown that solriamfetol may reduce the frequency of binge-eating episodes. The drug adjusts brain chemicals related to control and reward, which might lessen the urge to binge eat. While research specifically on BED continues, solriamfetol has proven effective in treating conditions like narcolepsy and sleep apnea, and it has helped some patients manage their weight. These findings offer hope that solriamfetol could benefit those dealing with BED. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with Binge Eating Disorder (BED) who are looking to participate in a study evaluating the long-term safety and effectiveness of a medication called Solriamfetol. Specific eligibility criteria details were not provided.

Inclusion Criteria

Completion of the treatment period in Study SOL-BED-301

Able to comply with study procedures

Exclusion Criteria

Significant change in vital signs, medical history or concomitant medications since enrolling in the SOL-BED-301 study which, in the opinion of the Investigator or the Medical Monitor, would render the subject unsuitable to receive solriamfetol or participate in the study

Timeline for a Trial Participant

Baseline

Initial assessment and baseline measurements before treatment begins

1 visit

Titration

Participants undergo a 2-week titration phase to adjust dosing of solriamfetol

2 weeks

Maintenance

Participants receive solriamfetol for long-term treatment of binge eating disorder

50 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Solriamfetol

Trial Overview The study is testing three different doses of Solriamfetol (75mg, 150 mg, or 300 mg) to determine its safety and efficacy over an extended period for treating BED in adults. It's an open-label, Phase 3 trial conducted across multiple centers.

How Is the Trial Designed?

Group I: Solriamfetol Experimental Treatment 1 Intervention

Up to 52 weeks.

Who Is Running the Clinical Trial?

Axsome Therapeutics, Inc.

Lead Sponsor

Trials

34

Recruited

11,600+

Published Research Related to This Trial

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]

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 study involving 745 adults with moderate to severe binge eating disorder, treatment with lisdexamfetamine dimesylate (LDX) significantly reduced binge eating days per week and improved obsessive-compulsive symptoms related to binge eating, with consistent results across different genders and age groups.

While LDX was effective, it was also associated with a higher frequency of treatment-emergent adverse events, including increases in blood pressure and pulse, indicating the need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Characteristics and Treatment Response to Lisdexamfetamine Dimesylate Versus Placebo in Adults With Binge Eating Disorder: Analysis by Gender and Age. Kornstein, SG., Bliss, C., Kando, J., et al.[2019]

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. trialx.com trialx.com/clinical-trials/listings/225072/solriamfetol-in-binge-eating-disorder/

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) ...

3. 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 ...

4. 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.

5. withpower.com withpower.com/trial/phase-3-binge-eating-disorder-1-2025-74aba

Solriamfetol for Binge Eating Disorder · Info for Participants In a study involving 745 adults with moderate to severe binge eating disorder, treatment with lisdexamfetamine dimesylate (LDX) significantly reduced binge ...

6. 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 ...

7. axsometherapeuticsinc.gcs-web.com axsometherapeuticsinc.gcs-web.com/node/11956/pdf

Axsome Therapeutics Announces Topline Results of ... Solriamfetol was safe and well tolerated in the trial, with a side ... binge eating disorder (BED), and excessive sleepiness associated.