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NCT01859013 · ClinicalTrials.gov registry record · Phase 2
Topiramate in Adolescents With Severe Obesity
A Phase 2 study of Obesity and Weight Loss, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT01859013 is a Phase 2 study of Obesity and Weight Loss that has completed, run by University of Minnesota. The registered enrollment target is 34 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01859013, a Phase 2 study of Obesity and Weight Loss, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
The prevalence of severe pediatric obesity is on the rise and youth with this condition are at elevated risk for developing chronic diseases such as cardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM). Topiramate, a medication approved by the Food and Drug Administration (FDA) for the treatment of seizures in adults and children, is associated with weight loss. Although not FDA approved for the treatment of obesity, studies in obese adults have demonstrated weight reduction of approximately 5% with 6-12 months of therapy. However, the weight loss effect of topiramate has never been evaluated among children and adolescents. Therefore, the goal of this pilot study is to evaluate the safety and efficacy of 24 weeks of topiramate therapy with a 4-week run-in of meal replacement therapy in adolescents with severe obesity. The primary hypothesis is that 4 weeks of meal replacement therapy followed by 24 weeks of topiramate will have a larger average percent decline in BMI between baseline and 28 weeks compared to meal replacement therapy followed by placebo.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Topiramate
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2013-06 |
| Est. Completion | 2017-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01859013
The ClinicalTrials.gov registry entry for NCT01859013 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (96% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01859013 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT01859013 about?
NCT01859013 is a clinical study titled "Topiramate in Adolescents With Severe Obesity". The prevalence of severe pediatric obesity is on the rise and youth with this condition are at elevated risk for developing chronic diseases such as cardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM). Topiramate, a medication approved by the Food and Drug Administration (FDA) for the t...
What is the current status of trial NCT01859013?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2013-06. Estimated completion is 2017-04.
What conditions does trial NCT01859013 study?
This clinical trial studies the following conditions: Obesity, Weight Loss, Obesity, Morbid.
What interventions are being tested in trial NCT01859013?
The interventions under investigation include: Placebo (OTHER), Topiramate (DRUG).
Who is sponsoring clinical trial NCT01859013?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01859013 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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