An Open-label Study of NRP104 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
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|ClinicalTrials.gov Identifier: NCT00337285|
Recruitment Status : Completed
First Posted : June 15, 2006
Results First Posted : July 17, 2009
Last Update Posted : August 20, 2012
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder Attention Deficit Disorders With Hyperactivity Attention Deficit Hyperactivity Disorders||Drug: Vyvanse (lisdexamfetamine dimesylate), NRP104||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||349 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Long-Term, Open-Label, and Single-Arm Study of NRP104 30 mg, 50 mg, or 70 mg Per Day in Adults With Attention Deficit Hyperactivity Disorder (ADHD)|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||June 2008|
Drug: Vyvanse (lisdexamfetamine dimesylate), NRP104
NRP104 capsule once-a-day orally beginning at 30mg/day and titrated by 20 mg per day at weekly intervals up to a maximum daily dose of 70 mg
- Change in ADHD-RS-IV Total Score From Baseline at Up to One Year [ Time Frame: up to one year ]Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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.
- Number of Participants With Improvement on CGI-I [ Time Frame: Up to 1 year ]Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes 1 and 2 on the scale.
- Change in PSQI Total Score From Baseline at Up to One Year [ Time Frame: up to 1 year ]Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire consisting of 18 items which generates seven component scores on a scale from 0 (better sleep) to 3 (worse sleep) resulting in a global score of 0-21, where a higher number reflects worse sleep quality.
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): NCT00337285
Show 45 Study Locations
|Principal Investigator:||Joseph Biederman, M.D.||Massachusetts General Hospital|