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

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Methylphenidate Transdermal System
Sponsored by
Noven Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Meadowbrook Research, Inc.
  • Psychiatric Centers at San Diego
  • Alpine Clinical Research Center
  • Miami Research Associates, Inc.
  • Capstone Clinical Research
  • Pedia Research, LLC
  • ProMed Pediatrics
  • Children's Specialized Hospital
  • North Carolina Neuropsychiatry PA
  • Ohio State University
  • IPS Research Company
  • Oregon Center for Clinical Investigations (OCCI, Inc.)
  • CNS Research Institute
  • Western Psychiatric Institute & Clinic
  • Claghorn-Lesem Research Clinic
  • ADHD Clinic of San Antonio
  • NeuroScience, Inc.
  • Monarch Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Methylphenidate Transdermal System

Placebo patch

Arm Description

Methylphenidate 27.5mg, 41.3mg, 55mg, and 82.5mg patches applied daily for 8 weeks

Placebo patch applied daily for 8 weeks

Outcomes

Primary Outcome Measures

Score on ADHD Rating Scale at 4 weeks

Secondary Outcome Measures

Parent rating scale
Parent Global Assessment
Medication Satisfaction Survey
ADHD Impact Module
Clinical Global Impressions Scale
Adverse events, lab tests, dermal evaluations, ECGs

Full Information

First Posted
September 7, 2005
Last Updated
July 8, 2015
Sponsor
Noven Therapeutics
Collaborators
Noven Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00151983
Brief Title
Safety & Tolerability of MTS in Children Aged 6-12 Diagnosed With ADHD & Previously Treated With Extended-Release Methylphenidate Therapy
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Noven Therapeutics
Collaborators
Noven Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylphenidate Transdermal System
Arm Type
Active Comparator
Arm Description
Methylphenidate 27.5mg, 41.3mg, 55mg, and 82.5mg patches applied daily for 8 weeks
Arm Title
Placebo patch
Arm Type
Placebo Comparator
Arm Description
Placebo patch applied daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Methylphenidate Transdermal System
Other Intervention Name(s)
MTS
Intervention Description
To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo
Primary Outcome Measure Information:
Title
Score on ADHD Rating Scale at 4 weeks
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Parent rating scale
Time Frame
30 days
Title
Parent Global Assessment
Time Frame
30 days
Title
Medication Satisfaction Survey
Time Frame
30 days
Title
ADHD Impact Module
Time Frame
30 days
Title
Clinical Global Impressions Scale
Time Frame
30 days
Title
Adverse events, lab tests, dermal evaluations, ECGs
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Meadowbrook Research, Inc.
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Psychiatric Centers at San Diego
City
San Marcos
State/Province
California
Country
United States
Facility Name
Alpine Clinical Research Center
City
Boulder
State/Province
Colorado
Country
United States
Facility Name
Miami Research Associates, Inc.
City
Miami
State/Province
Florida
Country
United States
Facility Name
Capstone Clinical Research
City
Libertyville
State/Province
Illinois
Country
United States
Facility Name
Pedia Research, LLC
City
Owensboro
State/Province
Kentucky
Country
United States
Facility Name
ProMed Pediatrics
City
Kalamazoo
State/Province
Michigan
Country
United States
Facility Name
Children's Specialized Hospital
City
Toms River
State/Province
New Jersey
Country
United States
Facility Name
North Carolina Neuropsychiatry PA
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Oregon Center for Clinical Investigations (OCCI, Inc.)
City
Portland
State/Province
Oregon
Country
United States
Facility Name
CNS Research Institute
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Western Psychiatric Institute & Clinic
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Claghorn-Lesem Research Clinic
City
Bellaire
State/Province
Texas
Country
United States
Facility Name
ADHD Clinic of San Antonio
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
NeuroScience, Inc.
City
Herndon
State/Province
Virginia
Country
United States
Facility Name
Monarch Medical Research
City
Norfolk
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20003260
Citation
Bukstein OG, Arnold LE, Landgraf JM, Hodgkins P. Does switching from oral extended-release methylphenidate to the methylphenidate transdermal system affect health-related quality-of-life and medication satisfaction for children with attention-deficit/hyperactivity disorder? Child Adolesc Psychiatry Ment Health. 2009 Dec 10;3(1):39. doi: 10.1186/1753-2000-3-39.
Results Reference
derived
PubMed Identifier
19916704
Citation
Arnold LE, Bozzolo DR, Hodgkins P, McKay M, Beckett-Thurman L, Greenbaum M, Bukstein O, Patel A. Switching from oral extended-release methylphenidate to the methylphenidate transdermal system: continued attention-deficit/hyperactivity disorder symptom control and tolerability after abrupt conversion. Curr Med Res Opin. 2010 Jan;26(1):129-37. doi: 10.1185/03007990903437412.
Results Reference
derived

Learn more about this trial

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

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