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

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00928148
First received: June 23, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Attention-Deficit/Hyperactivity Disorder
Drug: SPD465
Drug: Immediate Release Amphetamine Salt
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Multi-Center, Placebo- and Active-Controlled, Crossover Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 86
Study Start Date: March 2004
Study Completion Date: October 2004
Arms Assigned Interventions
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
Placebo Comparator: Placebo Drug: Placebo
Once daily for 7 days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Timothy Whitaker, M.D., Shire Pharmaceutical
ClinicalTrials.gov Identifier: NCT00928148     History of Changes
Other Study ID Numbers: SPD465-201
Study First Received: June 23, 2009
Last Updated: June 23, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Amphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on April 14, 2014