Safety of SPD465 in Treating Adults With ADHD.

Phase 3

Completed

• Conditions: Attention Deficit Disorder With Hyperactivity

• Registration Number: NCT00152035
• Lead Sponsor: Shire

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03-10
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-09
• Primary Completion: 2006-11-07
• Study Completion: 2006-11-07
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-19
• Last Update Posted: 2021-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 505

Inclusion Criteria

• Subject satisfied all entry criteria for the antecedent protocol (SPD465-301 or SPD465-303) and completed a minimum of 4 of the 7 weeks of double-blind treatment without experiencing any clinically significant adverse events.
• Subject must be male or non-pregnant female who agrees to comply with using acceptable contraceptive methods.

Exclusion Criteria

• Subject was terminated from antecedent protocol (SPD465-301 or SPD465-303) for non-compliance and/or experienced a serious adverse event or adverse event resulting in termination from the protocol.
• Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Asix I disorders.
• History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
• Females who are pregnant of lactating.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	Throughout the study period of approximately 20 months

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression of Improvement scale assessed at Visits 1 through 15/Early Termination (ET).	Baseline, Weekly for 4 weeks, and then Monthly for 5 months.
ADHD-rating scale (ADHD-RS-IV) taken at the Visit 1 and all visits thereafter.	Baseline, Weekly for 4 weeks, and then Monthly for 5 months.
Pittsburgh Sleep Quality Index (PSQI) - assessed at Visits 1 through 15/ET.	Baseline, Weekly for 4 weeks, and then Monthly for 5 months.