Back to resultsSafety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD and Previously Participated in MTS Trials
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Methylphenidate Transdermal System
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity
Eligibility Criteria
Inclusion Criteria: Subject must have participated in and completed SPD485-201 or participated in and completed a minimum of five of the seven weeks of double-blind treatment in study SPD485-302. Subjects who are participating in N17-021 may enroll in this study following completion of the End of Study/Termination visit procedures. Females of childbearing potential must have a negative urine pregnancy test at Baseline and must abstain from sexual activity that could result in pregnancy, or use acceptable contraceptives. Exclusion Criteria: Subject was terminated from SPD485-102, SPD495-201, SPD485-302 OR N17-021 for non-compliance or experienced a serious adverse event resulting in termination from the antecedent protocols Female subject is pregnant or lactating
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Methylphenidate transdermal system
Arm Description
MTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks
Outcomes
Primary Outcome Measures
Treatment emergent adverse events over 12 months.
Secondary Outcome Measures
ADHD-RS-IV scores
Parent Global Assessment
Clinical Global Impressions Scale
Child's Sleep Habits Questionnaire
Full Information
NCT ID
NCT00151957
First Posted
September 7, 2005
Last Updated
March 27, 2017
Sponsor
Noven Therapeutics
Collaborators
Noven Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00151957
Brief Title
Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD and Previously Participated in MTS Trials
Official Title
A Phase III, Multi-center, Open-label Study of Methylphenidate Transdermal System (MTS) in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (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 evaluate the long-term safety of MTS in the symptomatic treatment of children aged 6-12 diagnosed with ADHD
Detailed Description
Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will evaluate the long-term safety of SPD485 in the symptomatic treatment of children aged 6-12 diagnosed with ADHD
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
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methylphenidate transdermal system
Arm Type
Experimental
Arm Description
MTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks
Intervention Type
Drug
Intervention Name(s)
Methylphenidate Transdermal System
Other Intervention Name(s)
MTS
Intervention Description
MTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks
Primary Outcome Measure Information:
Title
Treatment emergent adverse events over 12 months.
Time Frame
Weekly
Secondary Outcome Measure Information:
Title
ADHD-RS-IV scores
Time Frame
Weekly
Title
Parent Global Assessment
Time Frame
Weekly
Title
Clinical Global Impressions Scale
Time Frame
Weekly
Title
Child's Sleep Habits Questionnaire
Time Frame
Weekly
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 participated in and completed SPD485-201 or participated in and completed a minimum of five of the seven weeks of double-blind treatment in study SPD485-302. Subjects who are participating in N17-021 may enroll in this study following completion of the End of Study/Termination visit procedures.
Females of childbearing potential must have a negative urine pregnancy test at Baseline and must abstain from sexual activity that could result in pregnancy, or use acceptable contraceptives.
Exclusion Criteria:
Subject was terminated from SPD485-102, SPD495-201, SPD485-302 OR N17-021 for non-compliance or experienced a serious adverse event resulting in termination from the antecedent protocols
Female subject is pregnant or lactating
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19808143
Citation
Findling RL, Wigal SB, Bukstein OG, Boellner SW, Abikoff HB, Turnbow JM, Civil R. Long-term tolerability of the methylphenidate transdermal system in pediatric attention-deficit/hyperactivity disorder: a multicenter, prospective, 12-month, open-label, uncontrolled, phase III extension of four clinical trials. Clin Ther. 2009 Aug;31(8):1844-55. doi: 10.1016/j.clinthera.2009.08.002.
Results Reference
background
Learn more about this trial
Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD and Previously Participated in MTS Trials
We'll reach out to this number within 24 hrs