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

This study has been completed.
Sponsor:
Collaborator:
Noven Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Noven Therapeutics
ClinicalTrials.gov Identifier:
NCT00151957
First received: September 7, 2005
Last updated: July 8, 2015
Last verified: July 2015
  Purpose

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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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)

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ADHD-RS-IV scores [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Parent Global Assessment [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Clinical Global Impressions Scale [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Child's Sleep Habits Questionnaire [ Time Frame: Weekly ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
Publications:
Responsible Party: Noven Therapeutics
ClinicalTrials.gov Identifier: NCT00151957     History of Changes
Other Study ID Numbers: SPD485-303
Study First Received: September 7, 2005
Last Updated: July 8, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Methylphenidate
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on July 30, 2015