Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD and Previously Participated in MTS Trials
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)
1 other identifier
interventional
450
0 countries
N/A
Brief Summary
This study will evaluate the long-term safety of MTS in the symptomatic treatment of children aged 6-12 diagnosed with ADHD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2004
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 9, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedMarch 28, 2017
March 1, 2017
2.7 years
September 7, 2005
March 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment emergent adverse events over 12 months.
Weekly
Secondary Outcomes (4)
ADHD-RS-IV scores
Weekly
Parent Global Assessment
Weekly
Clinical Global Impressions Scale
Weekly
Child's Sleep Habits Questionnaire
Weekly
Study Arms (1)
Methylphenidate transdermal system
EXPERIMENTALMTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks
Interventions
MTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Noven Therapeuticslead
- Noven Pharmaceuticals, Inc.collaborator
Related Publications (1)
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.
PMID: 19808143BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 9, 2005
Study Start
October 1, 2004
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
March 28, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share