Your session is about to expire
← Back to Search
Lisdexamfetamine for Binge Eating Disorder and Obesity
Study Summary
This trial will test whether lisdexamfetamine (LDX) is more effective than placebo as a maintenance therapy for binge-eating disorder (BED) in obese patients.
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
Find a Location
Who is running the clinical trial?
Media Library
- My diabetes is not currently under control.I have a condition affecting my gallbladder.My thyroid condition is not under control.I am allergic to the study medication or similar stimulants.My high blood pressure is not under control.The study team is available for the duration of the treatment and follow-up period (18 months).I am currently on a recognized treatment for eating or weight issues.You have a history of eating disorders like anorexia or bulimia, or you currently make yourself vomit on a regular basis.You have a serious mental illness that requires you to stay in the hospital or receive intense treatment.I am prone to having seizures.I have a history of serious heart conditions or high blood pressure.You are currently having thoughts of hurting yourself or someone else and have a plan to do so.You have had a problem with alcohol or drugs in the past or are currently struggling with it.I am between 18 and 64 years old.I can travel to New Haven, CT for weekly visits.You have binge-eating disorder, which means you frequently eat large amounts of food in a short period of time.I do not have severe kidney, liver, nerve, lung diseases or other serious health issues.I have had issues with LDX or similar medications before.I am currently taking medication for depression or other conditions that affects my brain's chemical balance.I am currently taking Vyvanse, Wellbutrin, Zyban, Naltrexone, or Contrave.I am currently taking opioid pain medications.I am not taking any medications that would interfere with the study drugs.I am not pregnant, breastfeeding, and I agree to use contraception.My heart health is cleared by an EKG and doctor's review.I am currently using medication for ADHD or psychostimulants.My BMI is between 27 and 50, and if it's under 30, I have a controlled obesity-related health issue.
- Group 1: LDX
- Group 2: Placebo
- 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 people still able to join this trial at its current stage?
"If you are reading this, it is likely that you qualify for the study. This trial was first posted on 8/7/2019 and updated as recently as 1/6/2022 according to clinicaltrials.gov."
Is this research study only available to people who are 20 years old or younger?
"The age restriction for this clinical study is between 18 to 64 years old."
Has this particular research been done before?
"LDX has been researched since 2018 when the first study, which was sponsored by Shire. After this initial 40-person trial concluded in 2018 and LDX received Phase 4 approval, there are now 6 active trials being conducted in 3 cities across 3 countries."
Who can sign up for this particular medical research program?
"This study is looking for 80 participants that suffer from binge-eating disorder and meet the following age, BMI, and medical criteria: between 18-64 years old, a Body Mass Index of 27-30 with controlled obesity co-morbidity; or a BMI of 30 to 50, and have no recent heart conditions as determined by EKG. Lastly, these individuals must be available for weekly visits over the course of 18 months."
Has the FDA cleared LDX for therapeutic use?
"LDX's safety is estimated to be a 3 out of 3. This score comes from the fact that LDX is in Phase 3 clinical trials, meaning there is evidence of efficacy as well as multiple rounds of data supporting its safety."
Is lenalidomide the only novel therapy being studied?
"Currently, there are 6 ongoing clinical trials looking into LDX with 3 of those in Phase 3. The majority of the research is taking place in Iowa City, although LDX is being studied at 6 different centres."
How many people are being welcomed into this test program?
"That is correct. The clinical trial is seeking 80 participants from 1 location, as per the most recent update on clinicaltrials.gov (1/6/2022)."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger