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Completed

NCT Number: NCT00151957

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

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

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylphenidate Transdermal System

Drug

MTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks

Other names: MTS

Primary outcomes

  1. Treatment emergent adverse events over 12 months.

    Time frame: Weekly

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Noven Therapeutics

Industry

Collaborators

  • Noven Pharmaceuticals, Inc.

Registry information

Official study 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)

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 9, 2005
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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