Solriamfetol for Binge Eating Disorder

AG
GG
Overseen ByGenie Groff
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

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.12345

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.13456

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.
See 4 more

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.
See 17 more

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?
2Treatment groups
Active Control
Placebo Group
Group I: SolriamfetolActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Solriamfetol is already approved in United States for the following indications:

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Approved in United States as Sunosi for:

Find a Clinic Near You

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 profile image

Bruce C. Cozadd

Jazz Pharmaceuticals

Chief Executive Officer since 2009

BA in Economics from Yale University, MBA from Stanford University

Dr. Austin profile image

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

Citations

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 ...
NCT04602936 | Solriamfetol in Binge Eating DisorderThe 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.govpubmed.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.
Solriamfetol hydrochloride by Axsome Therapeutics for ...According to GlobalData, Phase III drugs for Binge Eating Disorder have a 25% phase transition success rate (PTSR) indication benchmark for ...
5.axsometherapeuticsinc.gcs-web.comaxsometherapeuticsinc.gcs-web.com/node/11956/pdf
Axsome Therapeutics Announces Topline Results of ...In MDD patients with severe EDS (ESS score ≥16), solriamfetol treatment resulted in clinically meaningful and numerically greater improvements ...
Sunosi, INN-solriamfetol - EMAIn a large European. Sleep Apnoea Cohort study with over 6,000 subjects, severe OSA was associated with an increased likelihood (approximately a 2-fold increase) ...
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