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

Sponsor:	Shire Development LLC
Information provided by:	Shire Development LLC
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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by Shire Development LLC:

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

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:

Findling RL, Bukstein OG, Melmed RD, López FA, Sallee FR, Arnold LE, Pratt RD. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Methylphenidate Transdermal System in Pediatric Patients With Attention-Deficit/Hyperactivity Disorder. J Clin Psychiatry. 2008 Jan 3;:e1-e11 [Epub ahead of print]

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

Findling RL, Bukstein OG, Melmed RD, López FA, Sallee FR, Arnold LE, Pratt RD. A randomized, double-blind, placebo-controlled, parallel-group study of methylphenidate transdermal system in pediatric patients with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2008 Jan;69(1):149-59.

ClinicalTrials.gov Identifier:	NCT00444574 History of Changes
Other Study ID Numbers:	SPD485-302
Study First Received:	March 6, 2007
Last Updated:	May 6, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Shire Development LLC:

Attention Deficit Hyperactivity Disorder (ADHD)

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 May 24, 2012