Vyvanse and Glucose Intolerance in Children With Attention Deficit Hyperactivity Disorder (ADHD) and Obesity

This study has been terminated.
(Due very high screen fail rate, pre study feasibility not consistent with screened population.)
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01017263
First received: November 19, 2009
Last updated: February 18, 2014
Last verified: September 2013

November 19, 2009
February 18, 2014
December 2009
August 2012   (final data collection date for primary outcome measure)
Pre and Post Study Fasting Blood Sugar and Two Hour Post Prandial. [ Time Frame: Baseline to end of study ] [ Designated as safety issue: Yes ]
The study was terminated due to lack of enrollment therefore outcome measures were not assessed. If completed, the expected outcomes would have shown an improvement of the subject's fasting and 2 hour post prandial glucose values, insulin levels and HbA1c. However, all of the subjects recruited did not have abnormal values to start with. The two subjects who were enrolled were the younger kids to which the entry lab criteria do not apply.
Fasting and 2 hour post prandial glucose, insulin and HbA1c. [ Time Frame: Screening, Visit 7 and 11(end of study) ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01017263 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Vyvanse and Glucose Intolerance in Children With Attention Deficit Hyperactivity Disorder (ADHD) and Obesity
Vyvanse and Glucose Intolerance in Children With ADHD and Obesity

The purpose of this study to assess the effects of chronic administration of Vyvanse (lis-dexamphetamine) on glucose metabolism in a sample of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who also have glucose intolerance and are obese.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Attention Deficit Hyperactivity Disorder
  • Glucose Intolerance
  • Obesity
Drug: Lis-dexamphetamine
Eligible subjects will be dispensed open label LDX (VyvanseTM). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.
Other Name: Vyvanse, LDX
Active Comparator: Open label Vyvanse
Eligible subjects will be dispensed open label LDX (VyvanseTM). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.
Intervention: Drug: Lis-dexamphetamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • male or female, ages between 8 and 17
  • Body Mass Index > 30
  • fasting blood sugar between 90-100 mg/dl
  • 2 hour post prandial >140 <180 mg/dl
  • meets criteria for a diagnosis of ADHD, any subtype

Exclusion Criteria:

  • known cardiovascular disease or diabetes
  • structural cardiac abnormalities, abnormal ECGs, family history of sudden death
  • positive urine drug screen
  • fasting blood sugar level > 126 mg/dl
  • HbA1c > 6.5 %
  • Weight > 300 lbs
Both
8 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01017263
Pro00019063
No
Duke University
Duke University
Shire
Principal Investigator: Scott H Kollins, PhD Duke University
Duke University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP