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Efficacy and Safety of SPD465 in Adults With 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 sulfate, 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 sleep and how the participants 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 (CGI-I) - assessed at visits A1 through A7/Early Termination (ET)

Time-Sensitive ADHD Symptom Scale (TASS) - completed at the Baseline visit and twice daily throughout the remainder of the subjects participation in this study

Brown ADD Scale (BADDS) - completed at the Baseline and A7/ET visits

Adult ADHD Impact Module (AIM-A) - completed at the Baseline and A7/ET visits

Pittsburgh Sleep Quality Index (PSQI) - completed at every visit from Baseline to study completion/ET

Eligibility

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

Criteria:

Inclusion Criteria:

- Primary diagnosis of ADHD

- Baseline ADHD-RS-IV score >= 24

- 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

Locations and Contacts

Additional Information

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

Page last updated: August 20, 2015

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