The Safety and Efficacy of SPD465 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

June 1, 2021 updated by: Shire

A Phase 2, Randomized, Double-Blind, Multi-Center, Placebo- and Active-Controlled, Crossover Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder

This is a phase 2, randomized, multi-center, double-blind, 3-period and 3-treatment crossover study designed to evaluate the safety and duration of efficacy of SPD465 (50 or 75 mg) compared with placebo and an immediate release amphetamine salt formulation (25 mg) in adults with ADHD. The controlled environment used in this study is an analog classroom setting adapted for a 16-hour adult day.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 2

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:

  • Adult men and non-pregnant women between the ages of 18 and 55
  • Confirmed diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
  • Baseline ADHD score of at least 24

Exclusion Criteria:

  • Weight less than 100 pounds or greater than 250 pounds
  • Psychiatric diagnosis such as a severe comorbid Axis II or Axis I disorder
  • Pregnancy or breastfeeding
  • History of seizures
  • Positive urine drug screen

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Once daily for 7 days
Experimental: SPD465 (50 or 75 mg)
Drug: SPD465
50 or 75 mg once daily for 7 days
Active Comparator: Immediate Release Amphetamine salt (25 mg)
Drug: Immediate Release Amphetamine Salt
25 mg once daily for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the duration of efficacy of SPD465 compared to placebo and immediate release amphetamine formulation in adults with ADHD using the Permanent Product Measure of Performance (PERMP) math test
Time Frame: -0.5, 2, 4, 8, 12, 14 and 18 hours post-dose
-0.5, 2, 4, 8, 12, 14 and 18 hours post-dose

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the duration of efficacy of SPD465 compared with placebo and immediate release amphetamine on ADHD symptoms as determined by the ADHD-rating scale (ADHD-RS)
Time Frame: 5, 10 and 15 hours post-dose
5, 10 and 15 hours post-dose
To assess the duration of efficacy of SPD465 compared with placebo and immediate release amphetamine on ADHD symptoms as determined by the Swanson, Kotkin, Agler, M. Flynn, and Pelham (SKAMP) scale
Time Frame: 5, 10, and 15 hours post-dose
5, 10, and 15 hours post-dose
To assess the impact of SPD465 compared with placebo and immediate release amphetamine on sleep as measured by the modified Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 21 days
21 days
To evaluate the safety of SPD465 based on occurrence of treatment-emergent adverse events (TEAEs), blood pressure (BP), heart rate, electrocardiogram (ECG), and clinical laboratory findings
Time Frame: 21 days
21 days

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)

June 14, 2004

Primary Completion (Actual)

November 20, 2004

Study Completion (Actual)

November 20, 2004

Study Registration Dates

First Submitted

June 23, 2009

First Submitted That Met QC Criteria

June 23, 2009

First Posted (Estimate)

June 25, 2009

Study Record Updates

Last Update Posted (Actual)

June 3, 2021

Last Update Submitted That Met QC Criteria

June 1, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPD465-201

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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