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Completed

NCT Number: NCT00928148

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

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.

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Key information

Conditions

Attention-Deficit/Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPD465

Drug

50 or 75 mg once daily for 7 days

Immediate Release Amphetamine Salt

Drug

25 mg once daily for 7 days

Placebo

Drug

Once daily for 7 days

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Jun 25, 2009
Registry last updated
Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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