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NCT05416125 · ClinicalTrials.gov registry record · Early Phase 1
Vyvanse in Children Aged 6 to 12 Years
A Early Phase 1 study of Obesity, Childhood, sponsored by University of Minnesota.
- Active
- Registry status
- Early Phase 1
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT05416125: Active Early Phase 1 study of Obesity, Childhood, sponsored by University of Minnesota.
NCT05416125 is a Early Phase 1 study of Obesity, Childhood that is active but no longer recruiting, run by University of Minnesota. The registered enrollment target is 44 participants, below the 343-participant average among 53 other Obesity, Childhood trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05416125, a Early Phase 1 study of Obesity, Childhood, is active but no longer recruiting, sponsored by University of Minnesota.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The primary outcome is the percent change in body mass index (BMI) from randomization to Week 24
Conditions Studied
Interventions
- DRUG Lisdexamfetamine Dimesylate
- BEHAVIORAL Lifestyle therapy
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2023-12-20 |
| Est. Completion | 2027-07-31 |
| Phase | Early Phase 1 |
What the registry record for NCT05416125 still lists
NCT05416125 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 343-participant average among 53 other Obesity, Childhood trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Obesity, Childhood appearing as the primary indexed condition, and to 2 interventions - of which Lisdexamfetamine Dimesylate is the first listed.
NCT05416125 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT05416125 about?
NCT05416125 is a clinical study titled "Vyvanse in Children Aged 6 to 12 Years". 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.
What is the current status of trial NCT05416125?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 44 participants. The study started on 2023-12-20. Estimated completion is 2027-07-31.
What conditions does trial NCT05416125 study?
This clinical trial studies the following conditions: Obesity, Childhood.
What interventions are being tested in trial NCT05416125?
The interventions under investigation include: Lisdexamfetamine Dimesylate (DRUG), Lifestyle therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT05416125?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05416125 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05416125's enrollment target sits among peer trials
44 47th of 53 higher than 7 of 53 other Obesity, Childhood trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity, Childhood trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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