A Phase III, Multi-center, 12-month, Open-label Safety Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).

Shire0 sites505 target enrollmentMarch 10, 2005

ConditionsAttention Deficit Disorder With Hyperactivity

DrugsNeutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Attention Deficit Disorder With Hyperactivity
Sponsor: Shire
Enrollment: 505
Primary Endpoint: 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.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 10, 2005

End Date

November 7, 2006

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shire

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Time Frame: Throughout the study period of approximately 20 months

Secondary Outcomes

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.)