64 Participants Needed

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

Trial Summary

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

Solriamfetol is being studied for its effectiveness in treating binge eating disorder (BED) because it is a dopamine and norepinephrine reuptake inhibitor (DNRI), which may help reduce binge eating episodes. While direct evidence for solriamfetol in BED is still being evaluated, similar drugs like armodafinil have shown some promise in reducing binge eating episodes and related symptoms.12345

How is the drug Solriamfetol unique for treating Binge Eating Disorder?

Solriamfetol is unique for treating Binge Eating Disorder because it is primarily known for its use in treating sleep disorders like narcolepsy and obstructive sleep apnea, where it works by increasing wakefulness. This mechanism of action, which involves stimulating certain brain pathways, may offer a novel approach compared to traditional treatments for Binge Eating Disorder.678910

What is the purpose of this trial?

This trial tests solriamfetol, a medication that balances brain chemicals, in adults with Binge Eating Disorder (BED) to see if it can reduce their binge eating episodes.

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: SolriamfetolActive Control1 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: PlaceboPlacebo Group1 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

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

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

References

Study protocol and rationale for a randomized, placebo-controlled trial of solriamfetol to treat binge eating disorder. [2021]
Armodafinil in binge eating disorder: a randomized, placebo-controlled trial. [2022]
Pharmacological management of binge eating disorder: current and emerging treatment options. [2021]
Pharmacologic treatment of binge eating disorder. [2022]
A Review of Binge-Eating Disorder in Black Women: Treatment Recommendations and Implications for Healthcare Providers. [2023]
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. [2018]
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. [2022]
Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2†. [2023]
Comparative Treatment Patterns and Outcomes of Fulvestrant versus Everolimus Plus Exemestane for Postmenopausal Metastatic Breast Cancer Resistant to Aromatase Inhibitors in Real-World Experience. [2022]
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. [2020]
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