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Sponsors and Collaborators: |
University of California, Irvine Shire Pharmaceutical Development |
Information provided by: | University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT00733356 |
This is a single-blind, Investigator Initiated study to evaluate the safety and efficacy of Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on reading fluency and comprehension, over a period of approximately 6-8 weeks. Subjects will be between the ages of 6 and 12 at the beginning of the study.
Condition | Intervention | Phase |
Attention Deficit/Hyperactivity Disorder |
Drug: Vyvanse |
Phase IV |
ChemIDplus related topics: | Lisdexamfetamine Lisdexamfetamine dimesylate |
Study Type: | Interventional |
Study Design: | Basic Science, Single Blind (Outcomes Assessor), Dose Comparison, Single Group Assignment |
Official Title: | The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading |
Estimated Enrollment: | 28 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
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Show Detailed Description |
Ages Eligible for Study: | 6 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |||||
University of California, Irvine Child Development Center | Recruiting | ||||
Irvine, California, United States, 92697 | |||||
Contact: Audrey Kapelinski 949-824-1819 akapelin@uci.edu |
University of California, Irvine |
Shire Pharmaceutical Development |
Principal Investigator: | Kimberley Lakes, PhD | UC Irvine |
Responsible Party: | Univeristy of California, Irvine ( Kimberley Lakes, PhD. Principal Investigator ) |
Study ID Numbers: | VBHR |
First Received: | August 11, 2008 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00733356 |
Health Authority: | United States: Institutional Review Board; United States: Research Advisory Panel of California |
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