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Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD

This study has been completed.
Sponsor:
Collaborator:
Noven Pharmaceuticals
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00151970
First received: September 7, 2005
Last updated: June 23, 2009
Last verified: December 2008
History of Changes
  Purpose

Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.


Condition Intervention Phase
Attention Deficit Disorder With Hyperactivity
 Drug: 'd, I (threo)-methylphenidate, Methylphenidate Transdermal System
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase IIB, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Dose-Optimization, 3-Way Cross-Over, Analog Classroom Study to Assess the Efficacy, Duration of Effect, Tolerability and Safety of 4- and 6- Hour Wear Times of Methylphenidate Transdermal System (MTS) in Pediatric Subjects Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shire Development LLC:

Primary Outcome Measures:
  • SKAMP deportment rating scale

Secondary Outcome Measures:
  • PERMP age-adjusted math test
  • Clinician-rated ADHD-RS-IV
  • CGI-I
  • Parent Global Assessment
  • Connors' Parent Rating Scale
  • ADHD Impact Module-Children
  • SKAMP-total and inattention subscales

Enrollment: 128
Study Start Date: June 2005
Study Completion Date: October 2006
  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects have primary diagnosis of ADHD
  • Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test
  • Subject has an IQ score of >_ 80
  • Subject is able to complete as least the Basic Test of the PERMP assessment

Exclusion Criteria:

  • Subject has a comorbid psychiatric diagnosis such as Axis II disorders or severe Axis I disorders
  • Subject is taking Strattera(r)
  • Subject has a recent history of suspected substance abuse or dependence disorder
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
FDA Recall Information  This link exits the ClinicalTrials.gov site
FDA Medical Product Safety Alerts  This link exits the ClinicalTrials.gov site
FDA-approved Label  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00151970     History of Changes
Other Study ID Numbers: SPD485-304
Study First Received: September 7, 2005
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
Methylphenidate
 Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013