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Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD and Previously Participated in MTS Trials

This study has been completed.
Noven Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Noven Therapeutics Identifier:
First received: September 7, 2005
Last updated: March 27, 2017
Last verified: March 2017
This study will evaluate the long-term safety of MTS in the symptomatic treatment of children aged 6-12 diagnosed with ADHD

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Noven Therapeutics:

Primary Outcome Measures:
  • Treatment emergent adverse events over 12 months. [ Time Frame: Weekly ]

Secondary Outcome Measures:
  • ADHD-RS-IV scores [ Time Frame: Weekly ]
  • Parent Global Assessment [ Time Frame: Weekly ]
  • Clinical Global Impressions Scale [ Time Frame: Weekly ]
  • Child's Sleep Habits Questionnaire [ Time Frame: Weekly ]

Enrollment: 450
Study Start Date: October 2004
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methylphenidate transdermal system
MTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks
Drug: Methylphenidate Transdermal System
MTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks
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 evaluate the long-term safety of SPD485 in the symptomatic treatment of children aged 6-12 diagnosed with ADHD

Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Responsible Party: Noven Therapeutics Identifier: NCT00151957     History of Changes
Other Study ID Numbers: SPD485-303
Study First Received: September 7, 2005
Last Updated: March 27, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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 processed this record on April 25, 2017