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Solriamfetol for Binge Eating Disorder
Study Summary
This trial will test whether the drug solriamfetol can help reduce binge eating disorder.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You don't have episodes of excessive eating that only happen during bulimia nervosa or anorexia nervosa.I am not on medication that could interfere with the study drug.You have episodes of binge eating at least once a week for the past three months.I have not started any new mental health or weight loss treatments for binge eating disorder in the last 3 months.You often have episodes of eating a lot of food in a short time and feel like you can't control it.I have not taken any experimental drugs or long-acting antipsychotics in the last three months.You have a history of severe mental illnesses like psychosis, mania, or dementia.You feel very upset or bothered by your binge eating.You are allergic to solriamfetol or any of its ingredients.I have not taken any psychotropic drugs, except for sleep aids, in the last 4 weeks.I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am using effective birth control.You currently have bulimia nervosa or anorexia nervosa.I have a serious heart condition or have had a stroke.I have had seizures in the past, including as a child.I have narcolepsy or sleep apnea, or I'm taking medication to stay awake.I am between 18 and 65 years old.You have episodes of eating a lot of food quickly, eating until you feel very full, and feeling guilty or upset afterwards.You have been diagnosed with binge eating disorder (BED) according to the DSM-5 guidelines.I haven't used psychostimulants for dieting or misused them in the last 6 months.My blood pressure is not higher than 160/100 and my heart rate is not over 110.I do not have any unstable health conditions affecting my heart, liver, kidneys, stomach, lungs, or hormones.You are showing signs of wanting to harm yourself or others.
- Group 1: Placebo
- Group 2: Solriamfetol
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any recruitment openings for this research endeavor?
"Indeed, the data hosted on clinicaltrials.gov verifies that this medical study is currently recruiting patients. This trial was advertised since June 15th 2021 and has been revised as recently as January 18th 2022 with a goal of enlisting 64 individuals from 1 site."
Has the U.S. Food & Drug Administration (FDA) sanctioned Solriamfetol for public use?
"Our team has confidence in Solriamfetol's safety, as the drug is approved after undergoing a Phase 4 trial. This would logically result in it scoring a 3 on our scale of 1 to 3."
Is there an age ceiling for participants in this experiment?
"The inclusion criteria of this clinical trial stipulates that participants must be between 18 and 65 years old. Separate trials exist for individuals below the age of consent (46) and those over 65 (51)."
How many participants are there in this research endeavor?
"Affirmative, clinicaltrials.gov data suggests that this medical study is actively recruiting patients. This trial was originally advertised on June 15th 2021 and has since been updated on January 18th 2022. 64 participants are needed from 1 site to complete the experiment."
Is this particular research effort unprecedented?
"Since 2021, studies concerning the efficacy of Solriamfetol have been conducted. Jazz Pharmaceuticals was the sponsor for its first trial in that year; this experiment had 64 participants and resulted in Phase 4 drug approval. Currently, there are 3 ongoing trials across 2 cities within 1 nation."
What is the eligibility criterion for enrolling in this clinical experiment?
"The prerequisites for this medical trial include being between 18 and 65 years of age, and having an eating disorder. Presently, the team is looking to recruit 64 individuals."
Has Solriamfetol been subject to any other investigations in a clinical setting?
"Currently, 3 clinical trials are assessing the efficacy of Solriamfetol with one in its final stages. These studies primarily take place in Boston, MA but there are additional sites offering this research opportunity."
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