Safety of SPD465 in Treating Adults With 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 in the treatment of ADHD. The study will also look at how SPD465 affects sleep.
|Attention Deficit Disorder With Hyperactivity||Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.||Phase 3|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase III, Multi-center, 12-month, Open-label Safety 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 evaluation of safety will be based on the occurrence of treatment emergent AEs and specific evaluation of vitals signs, ECG, laboratory and physical examination.
Secondary Outcome Measures:
- ADHD-rating scale (ADHD-RS-IV) taken at the Visit 1 and all visits thereafter.
- Clinical Global Impression of Improvement scale assessed at Visits 1 through 15/Early Termination (ET).
- Pittsburgh Sleep Quality Index (PSQI) - assessed at Visits 1 through 15/ET.
|Study Start Date:||March 2005|
|Study Completion Date:||May 2007|
Contacts and Locations
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