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

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ClinicalTrials.gov Identifier: NCT00928148
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : June 25, 2009
Sponsor:
Information provided by:
Shire

Brief Summary:
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 or disease Intervention/treatment Phase
Attention-Deficit/Hyperactivity Disorder Drug: SPD465 Drug: Immediate Release Amphetamine Salt Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : March 2004
Actual Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Amphetamine
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Responsible Party: Timothy Whitaker, M.D., Shire Pharmaceutical
ClinicalTrials.gov Identifier: NCT00928148     History of Changes
Other Study ID Numbers: SPD465-201
First Posted: June 25, 2009    Key Record Dates
Last Update Posted: June 25, 2009
Last Verified: June 2009

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Amphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors