Solriamfetol for Binge Eating Disorder

Recruiting at 17 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

300 Participants Needed

Trial Summary

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.

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

Solriamfetol is being studied for its potential to help with binge eating disorder because it affects dopamine and norepinephrine, chemicals in the brain that are also targeted by other drugs like lisdexamfetamine, which has shown positive results in reducing binge eating episodes. ^{1 2 3 4 5}

Is solriamfetol safe for humans?

The study aims to evaluate the safety and tolerability of solriamfetol, a drug that affects brain chemicals, for treating binge eating disorder, but specific safety data from this study is not provided in the available information. ^{1 6 7 8 9}

What is the purpose of this trial?

This is a Phase 3, multi-center, open-label study to evaluate the long-term safety and efficacy of solriamfetol in the treatment of binge eating disorder (BED) in adults.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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

Duloxetine in obese binge eater outpatients: preliminary results from a 12-week open trial. [2022]

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

Effects of Lisdexamfetamine Dimesylate on Functional Impairment Measured on the Sheehan Disability Scale in Adults With Moderate-to-severe Binge Eating Disorder: Results from Two Randomized, Placebo-controlled Trials. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Investigational drugs for the treatment of binge eating disorder (BED): an update. [2019]

5. England pubmed.ncbi.nlm.nih.gov

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

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

A Phase 3, Multicenter, Open-Label, 12-Month Extension Safety and Tolerability Trial of Lisdexamfetamine Dimesylate in Adults With Binge Eating Disorder. [2022]

7. India pubmed.ncbi.nlm.nih.gov

Lisdexamfetamine for binge eating disorder in adults: a systematic review of the efficacy and safety profile for this newly approved indication - what is the number needed to treat, number needed to harm and likelihood to be helped or harmed? [2022]

8. United States 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. [2019]

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

Naltrexone-Bupropion and Behavior Therapy, Alone and Combined, for Binge-Eating Disorder: Randomized Double-Blind Placebo-Controlled Trial. [2023]