Efficacy and Safety of SPD465 in Adults With ADHD

June 25, 2021 updated by: Shire

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

240

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment.
Time Frame: Baseline, and the Endpoint (average of weeks 5, 6, 7).
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Baseline, and the Endpoint (average of weeks 5, 6, 7).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in the Clinical Global Impression of Improvement scale (CGI-I) to the Endpoint assessment.
Time Frame: Baseline, and the Endpoint (average of weeks 5, 6, 7).
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Baseline, and the Endpoint (average of weeks 5, 6, 7).
Change from Baseline in the Time-Sensitive ADHD Symptom Scale (TASS) score to the Endpoint assessment.
Time Frame: Baseline, and the Endpoint (average of weeks 5, 6, 7).
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Baseline, and the Endpoint (average of weeks 5, 6, 7).
Change from Baseline in the Brown Attention Deficit Disorder Scale (BADDS) to the Endpoint assessment
Time Frame: Baseline, and the Endpoint (average of weeks 5, 6, 7).
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Baseline, and the Endpoint (average of weeks 5, 6, 7).
Change in Baseline in the Adult ADHD Impact Module (AIM-A) score to the Endpoint assessment
Time Frame: Baseline, and the Endpoint (average of weeks 5, 6, 7).
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Baseline, and the Endpoint (average of weeks 5, 6, 7).
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 1
Time Frame: Baseline and Week 1.
Baseline and Week 1.
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 4
Time Frame: Baseline and Week 4.
Baseline and Week 4.
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 7
Time Frame: Baseline and Week 7.
Baseline and Week 7.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2005

Primary Completion (Actual)

June 14, 2005

Study Completion (Actual)

June 14, 2005

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Actual)

June 30, 2021

Last Update Submitted That Met QC Criteria

June 25, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPD465-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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