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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00151957
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : March 28, 2017
Noven Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Noven Therapeutics

Brief Summary:
This study will evaluate the long-term safety of MTS in the symptomatic treatment of children aged 6-12 diagnosed with ADHD

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: Methylphenidate Transdermal System Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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)
Study Start Date : October 2004
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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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

Responsible Party: Noven Therapeutics Identifier: NCT00151957     History of Changes
Other Study ID Numbers: SPD485-303
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
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