Safety and Efficacy of SPD465 in Adults With ADHD

June 21, 2021 updated by: Shire

A Phase II, Randomized, Double-Blind, Multi-center, Placebo-controlled, Crossover Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

The purpose of the study is to evaluate how safe and how well SPD465 works compared to placebo in adults with ADHD. It is hypothesized that SPD465 will achieve an extended duration of clinical benefit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
        • Clinical Study Center
    • California
      • Irvine, California, United States
        • UCI Child Development Center
    • Nevada
      • Las Vegas, Nevada, United States
        • Center for Psychiatry and Behavioral Medicine, Inc.
    • Texas
      • Houston, Texas, United States
        • Bayou City Research, Ltd.

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 using DSM-IV-TR criteria (at least 6 of the 9 subtype criteria met)
  • Baseline ADHD-RS-IV score =>24
  • IQ score of => 80 (using Kaufman Brief Intelligence Test)

Exclusion Criteria:

  • BMI < 18.5 or > 30 kg/m2
  • Diagnosis of Post Traumatic Stress Disorder, psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder
  • History of seizure disorder or a lifetime history of any seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or family history of Tourette's Disorder
  • History of uncontrolled hypertension or currently hypertensive
  • Subjects who have taken atomoxetine (STRATTERA) within 30 days prior to screening
  • Current (or history within the last 12 months) of drug dependence or substance abuse disorder according to DSM-IV-TR criteria (excluding nicotine)
  • Female subject is pregnant or lactating, less than 3 months post partum

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: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PERMP (Permanent Product Measure of Performance)
Time Frame: 0.5 hours pre-dosing
0.5 hours pre-dosing
PERMP (Permanent Product Measure of Performance)
Time Frame: 2 hours post-dosing
2 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Time Frame: 4 hours post-dosing
4 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Time Frame: 8 hours post-dosing
8 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Time Frame: 12 hours post-dosing
12 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Time Frame: 14 hours post-dosing
14 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Time Frame: 16 hours post-dosing
16 hours post-dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
Time Segment Rating System (ADHD-RS[TSRS])
Time Frame: 5½, 11, and 16½ hours post-dosing
5½, 11, and 16½ hours post-dosing
Subject self report (ADHD-SRS) of ADHD
Time Frame: approximately 5½, 11, and 16½ hours post-dosing
approximately 5½, 11, and 16½ hours post-dosing
Treatment emergent adverse events
Time Frame: Throughout the study period of approximately 3.25 months.
Throughout the study period of approximately 3.25 months.
Modified Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Study orientation and randomization visit, Week 1 after Study orientation and randomization visit, Week 2 after Study orientation and randomization visit
Study orientation and randomization visit, Week 1 after Study orientation and randomization visit, Week 2 after Study orientation and randomization visit

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)

September 29, 2005

Primary Completion (Actual)

January 6, 2006

Study Completion (Actual)

January 6, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Actual)

June 24, 2021

Last Update Submitted That Met QC Criteria

June 21, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPD465-203

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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