Vyvanse in Children Aged 6 to 12 Years (NCT05416125) | Clinical Trial Compass
CompletedEarly Phase 1
Vyvanse in Children Aged 6 to 12 Years
United States44 participantsStarted 2023-12-20
Plain-language 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.
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children ages 6 to \<12 years at study entry
* Severe obesity defined as BMI \>/= 1.2 times the 95th percentile at the screening visit
* Prior failed attempt of lifestyle therapy per parent/guardian report
* Written informed consent of parent/legal guardian and written assent of participant
Exclusion Criteria:
* Contraindications to lisdexamfetamine, including current or recent (\< 14 days) use of monoamine oxidase inhibitor and known hypersensitivity to amphetamine products
* Family history of sudden death or ventricular arrhythmia in any first or second degree relative with any of the following: sudden or unexplained death including sudden infant death syndrome, cardiomyopathy, heart transplant, familial arrhythmia (such as Wolff-Parkinson-White syndrome, long QT interval, or implantable defibrillator).
* Any history of fainting or seizure from exercise, startle, or fright
* Clinically significant congenital or structural heart disease or arrhythmia
* BMI \<1.2 times the 95th percentile at the baseline/randomization visits
* Hypertension defined as systolic blood pressure (SBP) and/or diastolic blood pressure (DBP) \>/= 95th percentile (on 3 separate occasions) at the screening OR baseline/randomization visits
* Tachycardia defined heart rate (HR) \>/= 120 bpm (on 3 separate occasions) at the screening OR baseline/randomization visits
* Current or recent (\< 3 months) use of psychostimulant or sympathomimetic amine
* History of chemical dependency
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.