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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Noven Therapeutics
ClinicalTrials.gov Identifier:
NCT00444574
First received: March 6, 2007
Last updated: June 23, 2015
Last verified: June 2015
  Purpose
Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with ADHD.

Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: Methylphenidate Transdermal System
Drug: Placebo
Drug: Concerta
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:


Further study details as provided by Noven Therapeutics:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CTRS-R, CPRS-R, CGI, PGA scores [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Treatment emergent AEs, dermal evaluations, PK [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Enrollment: 282
Study Start Date: September 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Methylphenidate Transdermal System
Methylphenidate 2.7mg, 41.3mg, 55mg, and 82.5mg patches for 7 weeks
Drug: Methylphenidate Transdermal System
The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA
Other Name: MTS
Placebo Comparator: Placebo
Placebp matching MTS and Concerta for 7 weeks
Drug: Placebo
The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA
Other Name: Sham treatment
Active Comparator: Concerta
Methylphenidate HCL 18mg tablet 7 weeks
Drug: Concerta
The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA
Other Name: Methylphenidate HCL

Detailed Description:
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).
  Eligibility

Ages Eligible for Study:   6 Years to 12 Years   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
Publications:
Responsible Party: Noven Therapeutics
ClinicalTrials.gov Identifier: NCT00444574     History of Changes
Other Study ID Numbers: SPD485-302 
Study First Received: March 6, 2007
Last Updated: June 23, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Noven Therapeutics:
Attention Deficit Hyperactivity Disorder (ADHD)

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

ClinicalTrials.gov processed this record on August 30, 2016