Safety & Tolerability of MTS in Children Aged 6-12 Diagnosed With ADHD & Previously Treated With Extended-Release Methylphenidate Therapy

This study has been completed.
Sponsor:
Collaborator:
Noven Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Noven Therapeutics
ClinicalTrials.gov Identifier:
NCT00151983
First received: September 7, 2005
Last updated: July 8, 2015
Last verified: July 2015
  Purpose

This study will assess the safety and tolerability of MTS while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.


Condition Intervention Phase
Attention Deficit Disorder With Hyperactivity
Drug: Methylphenidate Transdermal System
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Open-Label, Multi-Center Study Evaluating the Safety and Tolerability of Methylphenidate Transdermal System (MTS) in Children Aged 6-12 Previously Treated With Extended-Release Methylphenidate Product.

Resource links provided by NLM:


Further study details as provided by Noven Therapeutics:

Primary Outcome Measures:
  • Score on ADHD Rating Scale at 4 weeks [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parent rating scale [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Parent Global Assessment [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Medication Satisfaction Survey [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • ADHD Impact Module [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Clinical Global Impressions Scale [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Adverse events, lab tests, dermal evaluations, ECGs [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 175
Study Start Date: June 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Methylphenidate Transdermal System
Methylphenidate 27.5mg, 41.3mg, 55mg, and 82.5mg patches applied daily for 8 weeks
Drug: Methylphenidate Transdermal System
To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo
Other Name: MTS
Placebo Comparator: Placebo patch
Placebo patch applied daily for 8 weeks
Drug: Methylphenidate Transdermal System
To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo
Other Name: MTS

Detailed Description:

Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the safety and tolerability of SPD485 while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.

  Eligibility

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

Inclusion Criteria:

  • Subject must have a primary diagnosis of ADHD
  • Subject must be adequately controlled on a stable dose of one of the following medications for a 30 day period: Ritalin LA(r), Concerta(r), or Metadate DC(r), not to exceed 54 mg per day
  • Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin pregnancy test

Exclusion Criteria:

  • A history of mental retardation that would indicate that the subject is not functioning at an age appropriate level intellectually
  • A recent history of suspected substance abuse or dependence disorder
  • Subject is taking Strattera
  • Clinical signs and symptoms of skin irritation or hyper/hypopigmentation at the potential application sites
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151983

Locations
United States, Arizona
Meadowbrook Research, Inc.
Scottsdale, Arizona, United States
United States, California
Psychiatric Centers at San Diego
San Marcos, California, United States
United States, Colorado
Alpine Clinical Research Center
Boulder, Colorado, United States
United States, Florida
Miami Research Associates, Inc.
Miami, Florida, United States
United States, Illinois
Capstone Clinical Research
Libertyville, Illinois, United States
United States, Kentucky
Pedia Research, LLC
Owensboro, Kentucky, United States
United States, Michigan
ProMed Pediatrics
Kalamazoo, Michigan, United States
United States, New Jersey
Children's Specialized Hospital
Toms River, New Jersey, United States
United States, North Carolina
North Carolina Neuropsychiatry PA
Chapel Hill, North Carolina, United States
United States, Ohio
Ohio State University
Columbus, Ohio, United States
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States
United States, Oregon
Oregon Center for Clinical Investigations (OCCI, Inc.)
Portland, Oregon, United States
United States, Pennsylvania
CNS Research Institute
Philadelphia, Pennsylvania, United States
Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, United States
United States, Texas
Claghorn-Lesem Research Clinic
Bellaire, Texas, United States
ADHD Clinic of San Antonio
San Antonio, Texas, United States
United States, Virginia
NeuroScience, Inc.
Herndon, Virginia, United States
Monarch Medical Research
Norfolk, Virginia, United States
Sponsors and Collaborators
Noven Therapeutics
Noven Pharmaceuticals, Inc.
  More Information

No publications provided by Noven Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Noven Therapeutics
ClinicalTrials.gov Identifier: NCT00151983     History of Changes
Other Study ID Numbers: SPD485-305
Study First Received: September 7, 2005
Last Updated: July 8, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Methylphenidate
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on September 03, 2015