A Study of SPD465 in Young Adult Drivers With Attention-Deficit Hyperactivity Disorder (ADHD) Using Driving Simulators
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00458445|
Recruitment Status : Withdrawn (This study was stopped by the sponsor before enrollment based on a non-safety related corporate decision.)
First Posted : April 10, 2007
Last Update Posted : March 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Drug: SPD465||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|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)|
|Study Start Date :||April 2007|
- Driver Safety (DS) Score averaged over 3 driving assessments at one interim and one final visit.
- 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.
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): NCT00458445
|United States, Florida|
|Tampa, Florida, United States|
|Principal Investigator:||Cynthia Huffman, M.D.||Meridien Research|