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

Sponsor
Noven Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT00151970
Collaborator
Noven Pharmaceuticals, Inc. (Industry)
128
Enrollment
3
Arms
16
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Methylphenidate Transdermal System
  • Drug: Placebo
  • Drug: Concerta
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Jun 1, 2005
Actual Primary Completion Date :
Oct 1, 2006
Actual Study Completion Date :
Oct 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Methylphenidate Transdermal System

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

Drug: Methylphenidate Transdermal System
MTS 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes
Other Names:
  • MTS

    		•
    Placebo Comparator: Placebo

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

    Drug: Placebo
    Placebo patch 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes applied daily
    Other Names:
  • Sham Treatment

    		•
    Active Comparator: Concerta

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

    Drug: Concerta
    CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily
    Other Names:
  • Methylphenidate HCL

    		•

    Outcome Measures

    Primary Outcome Measures

    1. SKAMP deportment rating scale [Week 8]

    Secondary Outcome Measures

    1. PERMP age-adjusted math test [Week 8]

    2. Clinician-rated ADHD-RS-IV [Week 8]

    3. CGI-I [Week 8]

    4. Parent Global Assessment [Week 8]

    5. Connors' Parent Rating Scale [Week 8]

    6. ADHD Impact Module-Children [Week 8]

    7. SKAMP-total and inattention subscales [Week 8]

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Noven Therapeutics
    • Noven Pharmaceuticals, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Noven Therapeutics
    ClinicalTrials.gov Identifier:
    NCT00151970
    Other Study ID Numbers:
    • SPD485-304
    First Posted:
    Sep 9, 2005
    Last Update Posted:
    Jul 9, 2015
    Last Verified:
    Jul 1, 2015
    Additional relevant MeSH terms:
    Hyperkinesis
    Attention Deficit Disorder with Hyperactivity
    Methylphenidate

    Study Results

    No Results Posted as of Jul 9, 2015