Lifestyle therapy plus lisdexamfetamine for Pediatric Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Minnesota, Minneapolis, MN
Pediatric Obesity+2 More
Lisdexamfetamine Dimesylate - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
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Study Summary

This study will randomize children who have difficulty maintaining a healthy weight to one of two treatment groups: lifestyle therapy plus lisdexamfetamine or lifestyle therapy plus placebo.

Eligible Conditions

  • Pediatric Obesity
  • Obesity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 24 weeks

24 weeks
Percent change in Body Mass Index

Trial Safety

Trial Design

2 Treatment Groups

Lifestyle therapy plus lisdexamfetamine
1 of 2
Lifestyle therapy plus placebo
1 of 2
Active Control
Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: Lifestyle therapy plus lisdexamfetamine · Has Placebo Group · Phase < 1

Lifestyle therapy plus lisdexamfetamine
Drug
ActiveComparator Group · 1 Intervention: Lisdexamfetamine Dimesylate · Intervention Types: Drug
Lifestyle therapy plus placebo
Behavioral
PlaceboComparator Group · 1 Intervention: Lifestyle therapy · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks
Closest Location: University of Minnesota · Minneapolis, MN
Photo of University of Minnesota  1Photo of University of Minnesota  2Photo of University of Minnesota 3
1993First Recorded Clinical Trial
11 TrialsResearching Pediatric Obesity
830 CompletedClinical Trials

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,227 Previous Clinical Trials
1,454,363 Total Patients Enrolled
27 Trials studying Pediatric Obesity
4,934 Patients Enrolled for Pediatric Obesity

Eligibility Criteria

Age < 18 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a body mass index (BMI) of at least 1.2 times the 95th percentile.
You have a prior failed attempt of lifestyle therapy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.