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Safety and Efficacy of Methylphenidate Transdermal System (MTS) Versus Concerta in Pediatric Patients (Aged 6-12 Years) With ADHD

This study has been completed.

Sponsored by: Shire Pharmaceutical Development
Information provided by: Shire Pharmaceutical Development
ClinicalTrials.gov Identifier: NCT00444574
  Purpose

This is a phase III, randomized, double-blind, multi-center, parallel-group, placebo-controlled, dose optimization study designed to evaluate the safety and efficacy of MTS (12.5, 18.75, 25, and 37.5 cm2) compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with attention deficit hyperactivity disorder (ADHD).


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: Methylphenidate
Phase III

MedlinePlus related topics:   Attention Deficit Hyperactivity Disorder   

Drug Information available for:   Methylphenidate hydrochloride    Methylphenidate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) vs. CONCERTA® in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:
  • The primary objective of this study is to evaluate, under controlled conditions, the safety and efficacy of SPD485 (MTS) compared to placebo with reference to CONCERTA®, as determined by the change in the clinician completed ADHD-RS-IV at each visit. [ Time Frame: 7 weeks ]

Secondary Outcome Measures:
  • CTRS-R, CPRS-R, CGI, PGA scores [ Time Frame: 7 weeks ]
  • Treatment emergent AEs, dermal evaluations, PK [ Time Frame: 7 weeks ]

Enrollment:   282
Study Start Date:   September 2004
Study Completion Date:   June 2005

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

Criteria

Inclusion Criteria:

  • male or female aged 6-12 years
  • females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline.
  • a primary diagnosis of ADHD based on a detailed psychiatric evaluation
  • a total score of =>26 on the ADHD-RS-IV at the Baseline Visit
  • a minimum level of intellectual functioning, as determined by an IQ (based on KBIT) score of 80 or above
  • no comorbid illness that could affect safety or tolerability or in any way interfere with the subject's participation in the study.

EXCLUSION CRITERIA:

  • a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD) with significant symptoms such as Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder
  • a known non-responder to psychostimulant treatment
  • overweight (Body Mass Index (BMI)-for-age >90th percentile)
  • a history of seizures during the last 2 years (exclusive of infantile febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
  • Conduct Disorder.
  • Subject has taken an investigational drug within 30 days prior to Screening.
  Contacts and Locations

No Contacts or Locations Provided
  More Information


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Publications of Results:

Publications indexed to this study:

Study ID Numbers:   SPD485-302
First Received:   March 6, 2007
Last Updated:   February 25, 2008
ClinicalTrials.gov Identifier:   NCT00444574
Health Authority:   United States: Food and Drug Administration

Keywords provided by Shire Pharmaceutical Development:
Attention Deficit Hyperactivity Disorder (ADHD)  

Study placed in the following topic categories:
Signs and Symptoms
Dopamine
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Methylphenidate
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Stimulants
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 31, 2008




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