Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.
This study has been completed.
First Posted: September 9, 2005
Last Update Posted: January 16, 2017
Information provided by:
The purpose of this study is to assess the safety and effectiveness of SPD465 compared to placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also look at how SPD465 affects the participants sleep and how they perceive their quality of life.
|Attention Deficit Disorder With Hyperactivity||Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulphate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase III, Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel-Group, Safety and Efficacy Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).|
Resource links provided by NLM:
Drug Information available for: Dextroamphetamine sulfate Dextroamphetamine Amphetamine sulfate AmphetamineU.S. FDA Resources
Further study details as provided by Shire:
Primary Outcome Measures:
- The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) taken at the Baseline visit and all visits thereafter.
Secondary Outcome Measures:
- Clinical Global Impression of Improvement scale (CG(-I) - assessed at visits 1 through 6/Early Termination (ET)
- Brown ADD Scale (BADDS) - completed at Baseline and 6/ET visits
- Adult ADHD Impact Module (AIM-A)-completed at Baseline and 6/ET visits.
- Pittsburgh Sleep Quality Index (PSQI) - taken at every visit from Baseline to study completion.
|Study Start Date:||April 2005|
|Study Completion Date:||April 2006|
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