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Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.

Information source: Shire
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention Deficit Disorder With Hyperactivity.

Intervention: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulphate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate. (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Shire

Summary

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.

Clinical Details

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).

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: 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:

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.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Primary diagnosis of ADHD

- Baseline ADHD-RS-IV score >= 32

- Non-pregnant females of childbearing potential must comply with contraceptive

restrictions. Exclusion Criteria:

- Significantly underweight or morbidly obese

- Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or

severe Axis I disorders

- History of seizure, tic disorder, or a current diagnosis and/or family history of

Tourette's Disorder

- Females who are pregnant or lactating

Locations and Contacts

Additional Information

Starting date: April 2005
Last updated: November 2, 2007

Page last updated: August 20, 2015

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