A Study of SPD465 in Young Adult Drivers With Attention-Deficit Hyperactivity Disorder (ADHD) Using Driving Simulators
This study has been withdrawn prior to enrollment.
(This study was stopped by the sponsor before enrollment based on a non-safety related corporate decision.)
Information provided by:
First received: April 2, 2007
Last updated: April 7, 2008
Last verified: April 2008
The purpose of this study is to determine whether SPD465 is safe and effective in the treatment of ADHD in young adult drivers after a duration of 16 hours.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||A Phase IIIb Study to Evaluate the Efficacy and Time Course of Treatment With SPD465 Compared to Placebo on Simulated Driving Safety and Performance in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)|
Resource links provided by NLM:
Further study details as provided by Shire:
Primary Outcome Measures:
- Driver Safety (DS) Score averaged over 3 driving assessments at one interim and one final visit.
Secondary Outcome Measures:
- Simulated DS scores & individual components, averaged over the testing times. Interim & final visits: ADHD-RS-IV, CGI-I and Self-Rating of DS Performance Questionnaire. TEAEs, vital signs, lab parameters, physical exams & ECG measurements.
|Study Start Date:||April 2007|
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