Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study
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|ClinicalTrials.gov Identifier: NCT00764868|
Recruitment Status : Completed
First Posted : October 2, 2008
Results First Posted : March 28, 2011
Last Update Posted : February 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|ADHD||Drug: Lisdexamfetamine Dimesylate (LDX)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||269 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III, Open-Label, Extension, Multi-Center, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Adolescents Aged 13-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Lisdexamfetamine Dimesylate (LDX)
Drug: Lisdexamfetamine Dimesylate (LDX)
optimal dose of 30, 50 or 70 mg once daily
Other Name: Vyvanse
- Change From Baseline (From the Antecedent Study, SPD489-305) in the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at up to 52 Weeks [ Time Frame: Baseline and up to 52 weeks ]The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
- Percent of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) [ Time Frame: up to 52 weeks ]Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
- Change From Baseline (From the Antecedent Study, SPD489-305) in the Youth Quality of Life Instrument-Research Version (YQOL-R) Total Score at up to 52 Weeks [ Time Frame: Baseline and Up to 52 weeks ]The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764868
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|Principal Investigator:||Robert Findling, M.D.||University Hospitals of Cleveland Division of Child & Adolescent Psychiatry|