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Vyvanse in Children Aged 6 to 12 Years

Primary Purpose

Obesity, Childhood

Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lisdexamfetamine Dimesylate
Lifestyle therapy
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Childhood focused on measuring Obesity

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children ages 6 to <12 years at study entry
  • Severe obesity defined as BMI >/= 1.2 times the 95th percentile
  • 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
  • Clinically significant congenital or structural heart disease or arrhythmia
  • Hypertension defined as systolic blood pressure (SBP) and/or diastolic blood pressure (DBP) >/= 95th percentile
  • Tachycardia defined heart rate (HR) >/= 120 bpm
  • Current or recent (< 3 months) use of psychostimulant or sympathomimetic amine
  • History of chemical dependency
  • Positive urine drug screen
  • Diabetes mellitus (type 1 or 2)
  • Current or recent (< 3 months) use of anti-obesity medication(s)
  • Previous bariatric surgery
  • Recent initiation or change in dose (< 3 months prior) of anti-hypertensive or lipid medication(s)
  • Thyroid stimulating hormone (TSH) > 1.5x upper limit of normal (ULN)
  • Aspartate transaminase (AST) or alanine transaminase (ALT) > 3x ULN
  • Fasting glucose >/= 126 mg/dL
  • History of mania, schizophrenia, bipolar disorder, or psychosis
  • Unstable depression or anxiety that has required hospitalization in the past 12 months
  • Any history of suicide attempt
  • Columbia Suicide Severity Rating Scale (C-SSRS) of type 4 or 5 in past month
  • Children's Depressive Inventory 2 (CDE-2_ score >/= 70
  • Concomitant use of tricyclic antidepressants, selective serotonin re-uptake inhibitors (SSRIs), serotonin and norepinephrine re-uptake inhibitors (SNRIs), lithium, fentanyl, tramadol, triptans, tryptophan, buspirone and St. John's wort
  • Refusal to use adequate contraception (double barrier method or stable hormonal contraception plus single barrier method, tubal ligation, or abstinence) in girls of childbearing potential

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Lifestyle therapy plus placebo

Lifestyle therapy plus lisdexamfetamine

Arm Description

Individuals randomized to this arm will receive lifestyle therapy plus placebo for 24 weeks.

Individuals randomized to this arm will receive lifestyle therapy plus lisdexamfetamine for 24 weeks.

Outcomes

Primary Outcome Measures

Percent change in Body Mass Index
The primary outcome is the percent change in body mass index (BMI) from randomization to Week 24

Secondary Outcome Measures

Full Information

First Posted
June 8, 2022
Last Updated
October 2, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05416125
Brief Title
Vyvanse in Children Aged 6 to 12 Years
Official Title
Lisdexamfetamine for the Treatment of Severe Obesity in Children Aged 6 to 12 Years
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 30, 2028 (Anticipated)
Study Completion Date
November 30, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
This pilot study will enroll up to 40 children aged 6 to 12 years who have severe obesity. Individuals will be randomized to receive lifestyle therapy plus lisdexamfetamine or lifestyle therapy plus placebo. Participants will receive therapy for 24 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood
Keywords
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle therapy plus placebo
Arm Type
Placebo Comparator
Arm Description
Individuals randomized to this arm will receive lifestyle therapy plus placebo for 24 weeks.
Arm Title
Lifestyle therapy plus lisdexamfetamine
Arm Type
Active Comparator
Arm Description
Individuals randomized to this arm will receive lifestyle therapy plus lisdexamfetamine for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Lisdexamfetamine Dimesylate
Intervention Description
Vyvanse treatment
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle therapy
Intervention Description
Lifestyle treatment
Primary Outcome Measure Information:
Title
Percent change in Body Mass Index
Description
The primary outcome is the percent change in body mass index (BMI) from randomization to Week 24
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children ages 6 to <12 years at study entry Severe obesity defined as BMI >/= 1.2 times the 95th percentile 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 Clinically significant congenital or structural heart disease or arrhythmia Hypertension defined as systolic blood pressure (SBP) and/or diastolic blood pressure (DBP) >/= 95th percentile Tachycardia defined heart rate (HR) >/= 120 bpm Current or recent (< 3 months) use of psychostimulant or sympathomimetic amine History of chemical dependency Positive urine drug screen Diabetes mellitus (type 1 or 2) Current or recent (< 3 months) use of anti-obesity medication(s) Previous bariatric surgery Recent initiation or change in dose (< 3 months prior) of anti-hypertensive or lipid medication(s) Thyroid stimulating hormone (TSH) > 1.5x upper limit of normal (ULN) Aspartate transaminase (AST) or alanine transaminase (ALT) > 3x ULN Fasting glucose >/= 126 mg/dL History of mania, schizophrenia, bipolar disorder, or psychosis Unstable depression or anxiety that has required hospitalization in the past 12 months Any history of suicide attempt Columbia Suicide Severity Rating Scale (C-SSRS) of type 4 or 5 in past month Children's Depressive Inventory 2 (CDE-2_ score >/= 70 Concomitant use of tricyclic antidepressants, selective serotonin re-uptake inhibitors (SSRIs), serotonin and norepinephrine re-uptake inhibitors (SNRIs), lithium, fentanyl, tramadol, triptans, tryptophan, buspirone and St. John's wort Refusal to use adequate contraception (double barrier method or stable hormonal contraception plus single barrier method, tubal ligation, or abstinence) in girls of childbearing potential
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Fox, MD
Phone
(612) 626-6616
Email
lusc0001@umn.edu
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Fox, MD
Phone
612-626-6616
Email
lusc0001@umn.edu
First Name & Middle Initial & Last Name & Degree
Lisa Hostetler, BA
Phone
(612) 624-0149
Email
hoste005@umn.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Vyvanse in Children Aged 6 to 12 Years

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