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Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Methylphenidate Transdermal System
Placebo
Concerta
Sponsored by
Noven Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects have primary diagnosis of ADHD Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test Subject has an IQ score of >_ 80 Subject is able to complete as least the Basic Test of the PERMP assessment Exclusion Criteria: Subject has a comorbid psychiatric diagnosis such as Axis II disorders or severe Axis I disorders Subject is taking Strattera(r) Subject has a recent history of suspected substance abuse or dependence disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Placebo Comparator

    Active Comparator

    Arm Label

    Methylphenidate Transdermal System

    Placebo

    Concerta

    Arm Description

    The duration of MTS patch wear was 9 hours per day. A new patch was applied each morning upon awakening.

    The duration of placebo patch wear was 9 hours per day. A new patch was applied each morning upon awakening.

    CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily

    Outcomes

    Primary Outcome Measures

    SKAMP deportment rating scale

    Secondary Outcome Measures

    PERMP age-adjusted math test
    Clinician-rated ADHD-RS-IV
    CGI-I
    Parent Global Assessment
    Connors' Parent Rating Scale
    ADHD Impact Module-Children
    SKAMP-total and inattention subscales

    Full Information

    First Posted
    September 7, 2005
    Last Updated
    July 8, 2015
    Sponsor
    Noven Therapeutics
    Collaborators
    Noven Pharmaceuticals, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00151970
    Brief Title
    Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD
    Official Title
    A Phase IIB, Randomized, Double-blind, Multi-Center, Placebo-Controlled, Dose-Optimization, 3-way Cross-Over, Analog Classroom Study to Assess the Efficacy, Duration of Effect, Tolerability and Safety of 4- and 6- Hour Wear Times of Methylphenidate Transdermal System (MTS) in Pediatric Subjects Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2005 (undefined)
    Primary Completion Date
    October 2006 (Actual)
    Study Completion Date
    October 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Noven Therapeutics
    Collaborators
    Noven Pharmaceuticals, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.
    Detailed Description
    Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Attention Deficit Disorder With Hyperactivity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    128 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Methylphenidate Transdermal System
    Arm Type
    Active Comparator
    Arm Description
    The duration of MTS patch wear was 9 hours per day. A new patch was applied each morning upon awakening.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    The duration of placebo patch wear was 9 hours per day. A new patch was applied each morning upon awakening.
    Arm Title
    Concerta
    Arm Type
    Active Comparator
    Arm Description
    CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily
    Intervention Type
    Drug
    Intervention Name(s)
    Methylphenidate Transdermal System
    Other Intervention Name(s)
    MTS
    Intervention Description
    MTS 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Sham Treatment
    Intervention Description
    Placebo patch 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes applied daily
    Intervention Type
    Drug
    Intervention Name(s)
    Concerta
    Other Intervention Name(s)
    Methylphenidate HCL
    Intervention Description
    CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily
    Primary Outcome Measure Information:
    Title
    SKAMP deportment rating scale
    Time Frame
    Week 8
    Secondary Outcome Measure Information:
    Title
    PERMP age-adjusted math test
    Time Frame
    Week 8
    Title
    Clinician-rated ADHD-RS-IV
    Time Frame
    Week 8
    Title
    CGI-I
    Time Frame
    Week 8
    Title
    Parent Global Assessment
    Time Frame
    Week 8
    Title
    Connors' Parent Rating Scale
    Time Frame
    Week 8
    Title
    ADHD Impact Module-Children
    Time Frame
    Week 8
    Title
    SKAMP-total and inattention subscales
    Time Frame
    Week 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects have primary diagnosis of ADHD Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test Subject has an IQ score of >_ 80 Subject is able to complete as least the Basic Test of the PERMP assessment Exclusion Criteria: Subject has a comorbid psychiatric diagnosis such as Axis II disorders or severe Axis I disorders Subject is taking Strattera(r) Subject has a recent history of suspected substance abuse or dependence disorder

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18434918
    Citation
    Wilens TE, Boellner SW, Lopez FA, Turnbow JM, Wigal SB, Childress AC, Abikoff HB, Manos MJ. Varying the wear time of the methylphenidate transdermal system in children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2008 Jun;47(6):700-708. doi: 10.1097/CHI.0b013e31816bffdf.
    Results Reference
    background
    PubMed Identifier
    20973706
    Citation
    Frazier TW, Weiss M, Hodgkins P, Manos MJ, Landgraf JM, Gibbins C. Time course and predictors of health-related quality of life improvement and medication satisfaction in children diagnosed with attention-deficit/hyperactivity disorder treated with the methylphenidate transdermal system. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):355-64. doi: 10.1089/cap.2009.0092.
    Results Reference
    derived
    PubMed Identifier
    19849639
    Citation
    Manos M, Frazier TW, Landgraf JM, Weiss M, Hodgkins P. HRQL and medication satisfaction in children with ADHD treated with the methylphenidate transdermal system. Curr Med Res Opin. 2009 Dec;25(12):3001-10. doi: 10.1185/03007990903388797.
    Results Reference
    derived
    Links:
    URL
    http://www.fda.gov/opacom/7alerts.html
    Description
    FDA Recall Information

    Learn more about this trial

    Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD

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