Solriamfetol for Binge Eating Disorder

Overseen By Genie Groff

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Lindner Center of HOPE

Must not be taking: Antidepressants, Antipsychotics, Mood stabilizers, others

Disqualifiers: Bulimia, Anorexia, Psychosis, others

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: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness and tolerability of solriamfetol for treating binge eating disorder (BED). Solriamfetol affects brain chemicals to help control urges to binge eat. Participants will receive either solriamfetol or a placebo (an inactive pill) to compare outcomes. Individuals who have experienced frequent binge eating episodes, at least three times a week for the past week, might be a good fit for this trial.

As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial requires that you stop taking any psychotropic medications (medications affecting mood, perception, or behavior) at least four weeks before starting the study. This includes antidepressants, antipsychotics, mood stabilizers, and psychostimulants. If you are on any medications that might interact with the study drug, like warfarin or anticonvulsants, you may also need to stop those.

What is the safety track record for solriamfetol?

Research has shown that solriamfetol is generally safe and well-tolerated in people. In previous studies, the observed side effects were expected and manageable. Solriamfetol has already received approval for other uses, providing some reassurance about its safety. While no treatment is without risk, current evidence suggests that solriamfetol is a relatively safe option for those considering joining a clinical trial for binge eating disorder. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for binge eating disorder, which typically include options like cognitive behavioral therapy and medications such as selective serotonin reuptake inhibitors (SSRIs), solriamfetol offers a novel approach by acting as a dopamine and norepinephrine reuptake inhibitor. This unique mechanism of action potentially enhances focus and energy levels, which could help reduce binge-eating episodes. Researchers are excited about solriamfetol because it might provide quicker behavioral improvements compared to other medications, offering a promising alternative for those who don't respond well to existing treatments.

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

This trial will evaluate the effectiveness of solriamfetol for binge eating disorder (BED). Research has shown that solriamfetol, a type of medication, is effective for certain conditions. It is approved for treating excessive daytime sleepiness in people with narcolepsy and sleep apnea. Although direct evidence for its use in BED is limited, its mechanism suggests it might help reduce binge eating episodes. Solriamfetol increases levels of certain brain chemicals, dopamine and norepinephrine, which can influence mood and impulse control. Early signs are promising, but more research is needed to confirm its effectiveness for BED specifically. Participants in this trial will receive either solriamfetol or a placebo to assess its potential benefits for BED. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with Binge Eating Disorder (BED), experiencing significant distress and at least three binge-eating days per week. They must meet DSM-5 criteria for BED without a history of bulimia or anorexia nervosa. Excluded are pregnant individuals, those with recent substance abuse, serious psychiatric or medical conditions, uncontrolled hypertension or heart issues, misuse of stimulants, and anyone on certain medications.

Inclusion Criteria

You don't have episodes of excessive eating that only happen during bulimia nervosa or anorexia nervosa.

You have episodes of binge eating at least once a week for the past three months.

You often have episodes of eating a lot of food in a short time and feel like you can't control it.

Exclusion Criteria

Body mass index (BMI) ≤ 18 mg/kg2.

I am not on medication that could interfere with the study drug.

I have not started any new mental health or weight loss treatments for binge eating disorder in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive solriamfetol or placebo for 12 weeks, with weekly evaluations for the first 4 weeks and biweekly evaluations for the next 8 weeks

12 weeks

4 weekly visits, 4 biweekly visits

Treatment Discontinuation

Participants discontinue treatment and are monitored for any withdrawal effects

1 week

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 study tests the effectiveness and safety of solriamfetol—a drug affecting dopamine and norepinephrine—in treating BED against a placebo. Participants will be randomly assigned to receive either solriamfetol or a placebo to compare outcomes.

How Is the Trial Designed?

Group I: Solriamfetol Active Control 1 Intervention

All medication will be 37.5 mg encapsulated soriamfetol tablets or matching encapsulated placebo tablets supplied in numbered containers for dispensing to patients. The minimum dose of solriamfetol during the trial will be 37.5 mg/day; the maximum dose will be 150 mg/day. At the Baseline Visit (Visit 0), participants will be instructed to take one capsule of solriamfetol 37.5 mg or matching placebo in the morning for the first 7 days. Thereafter, at Visit 1, solriamfetol or placebo will be increased to 75 mg/day, if tolerated. Beginning on day 15 (Visit 2), solriamfetol or placebo will be increased to 150 mg/day, if tolerated. Study medication dosage may be decreased, or a scheduled increase may not be made, because of side effects. Study medication will be administered as a single daily dose in the morning.

Group II: Placebo Placebo Group 1 Intervention

Placebo (i.e., inactive compound for comparison)

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?

Lindner Center of HOPE

Lead Sponsor

Trials

29

Recruited

1,400+

Jazz Pharmaceuticals

Industry Sponsor

Trials

252

Recruited

35,100+

Bruce C. Cozadd

Jazz Pharmaceuticals

Chief Executive Officer since 2009

BA in Economics from Yale University, MBA from Stanford University

Dr. Austin

Jazz Pharmaceuticals

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Published Research Related to This Trial

The BOLERO-2 study found that adding everolimus (EVE) to exemestane (EXE) significantly improved progression-free survival (PFS) in postmenopausal women with hormone-receptor-positive advanced breast cancer, with a median PFS increase of 4.6 months.

However, the addition of EVE did not result in a statistically significant improvement in overall survival (OS), with median OS being 31.0 months for the EVE + EXE group compared to 26.6 months for the placebo + EXE group, indicating that while EVE enhances PFS, it does not extend overall survival significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2†. Piccart, M., Hortobagyi, GN., Campone, M., et al.[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]

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]

In a study of 168 hormone receptor-positive, HER2-negative metastatic breast cancer patients, treatment with the combination of everolimus and exemestane (EVE-EXE) showed a significant improvement in progression-free survival (PFS) for those with multiple metastatic sites compared to fulvestrant (FUL), with median PFS of 6.1 months versus 3.2 months.

Despite comparable overall clinical outcomes between the two treatments after adjusting for confounding factors, more patients in the EVE-EXE group discontinued treatment due to adverse events, indicating a potential trade-off between efficacy and tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Treatment Patterns and Outcomes of Fulvestrant versus Everolimus Plus Exemestane for Postmenopausal Metastatic Breast Cancer Resistant to Aromatase Inhibitors in Real-World Experience. Li, Y., Xie, Y., Gong, C., et al.[2022]

The EVA study, involving 404 patients with HR+ advanced breast cancer, demonstrated that the combination of Everolimus (EVE) and Exemestane (EXE) is safe, with an overall response rate (ORR) of 31.6% and a disease control rate (DCR) of 60.7%.

Patients who received the full dose of EVE or had prior treatment with Fulvestrant showed better treatment responses, highlighting the importance of dose intensity and previous therapies in optimizing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of Everolimus and Exemestane in hormone-receptor positive (HR+) human-epidermal-growth-factor negative (HER2-) advanced breast cancer patients: New insights beyond clinical trials. The EVA study. Cazzaniga, ME., Airoldi, M., Arcangeli, V., et al.[2018]

In the SoFEA trial involving 723 postmenopausal women with advanced hormone-receptor-positive breast cancer, the combination of fulvestrant and anastrozole did not show a significant improvement in progression-free survival compared to fulvestrant alone or exemestane, indicating that this double endocrine treatment may not be more effective than existing options.

The study reported a low incidence of serious adverse events across all treatment groups, suggesting that the treatments were generally safe, with common side effects being manageable and not significantly different among the groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fulvestrant plus anastrozole or placebo versus exemestane alone after progression on non-steroidal aromatase inhibitors in postmenopausal patients with hormone-receptor-positive locally advanced or metastatic breast cancer (SoFEA): a composite, multicentre, phase 3 randomised trial. Johnston, SR., Kilburn, LS., Ellis, P., et al.[2022]

In the BOLERO-2 trial, the combination of everolimus (EVE) and exemestane (EXE) significantly prolonged progression-free survival (PFS) in postmenopausal women with hormone-receptor-positive, HER2-negative advanced breast cancer, especially in those with visceral metastases, showing a median PFS of 6.8 months compared to 2.8 months with placebo plus EXE.

The efficacy of EVE+EXE was consistent across different performance statuses, with patients having a performance status of 0 experiencing a median PFS of 6.8 months and those with a performance status of ≥1 seeing a more than threefold increase in median PFS (6.8 months vs. 1.5 months), highlighting the treatment's effectiveness regardless of disease severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of visceral metastases on the efficacy and safety of everolimus in postmenopausal women with advanced breast cancer: subgroup analysis from the BOLERO-2 study. Campone, M., Bachelot, T., Gnant, M., et al.[2020]

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]

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]

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]

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