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Safety and Efficacy of MTS Versus Concerta in Pediatric Patients (Aged 6-12 Years) With ADHD

Sponsor
Noven Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT00444574
Collaborator
(none)
282
Enrollment
3
Arms
9
Duration (Months)

Study Details

Study Description

Brief Summary

Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with ADHD.

Condition or Disease Intervention/Treatment Phase
  • Drug: Methylphenidate Transdermal System
  • Drug: Placebo
  • Drug: Concerta
 Phase 3

Detailed Description

This is a phase III, randomized, double-blind, multi-center, parallel-group, placebo-controlled, dose optimization study designed to evaluate the safety and efficacy of MTS (12.5, 18.75, 25, and 37.5 cm2) compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with attention deficit hyperactivity disorder (ADHD).

Study Design

Study Type:
Interventional
Actual Enrollment :
282 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) vs. CONCERTA® in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study Start Date :
Sep 1, 2004
Actual Primary Completion Date :
Jun 1, 2005
Actual Study Completion Date :
Jun 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Methylphenidate Transdermal System

Methylphenidate 2.7mg, 41.3mg, 55mg, and 82.5mg patches for 7 weeks

Drug: Methylphenidate Transdermal System
The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA
Other Names:
  • MTS

    		•
    Placebo Comparator: Placebo

    Placebp matching MTS and Concerta for 7 weeks

    Drug: Placebo
    The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA
    Other Names:
  • Sham treatment

    		•
    Active Comparator: Concerta

    Methylphenidate HCL 18mg tablet 7 weeks

    Drug: Concerta
    The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA
    Other Names:
  • Methylphenidate HCL

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The primary objective of this study is to evaluate, under controlled conditions, the safety and efficacy of SPD485 (MTS) compared to placebo with reference to CONCERTA®, as determined by the change in the clinician completed ADHD-RS-IV at each visit. [7 weeks]

    Secondary Outcome Measures

    1. CTRS-R, CPRS-R, CGI, PGA scores [7 weeks]

    2. Treatment emergent AEs, dermal evaluations, PK [7 weeks]

    Eligibility Criteria

    Criteria

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

    • male or female aged 6-12 years

    • females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline.

    • a primary diagnosis of ADHD based on a detailed psychiatric evaluation

    • a total score of =>26 on the ADHD-RS-IV at the Baseline Visit

    • a minimum level of intellectual functioning, as determined by an IQ (based on KBIT) score of 80 or above

    • no comorbid illness that could affect safety or tolerability or in any way interfere with the subject's participation in the study.

    EXCLUSION CRITERIA:

    • a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD) with significant symptoms such as Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder

    • a known non-responder to psychostimulant treatment

    • overweight (Body Mass Index (BMI)-for-age >90th percentile)

    • a history of seizures during the last 2 years (exclusive of infantile febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.

    • Conduct Disorder.

    • Subject has taken an investigational drug within 30 days prior to Screening.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Noven Therapeutics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Noven Therapeutics
    ClinicalTrials.gov Identifier:
    NCT00444574
    Other Study ID Numbers:
    • SPD485-302
    First Posted:
    Mar 8, 2007
    Last Update Posted:
    Jun 25, 2015
    Last Verified:
    Jun 1, 2015
    Keywords provided by Noven Therapeutics
    Attention Deficit Hyperactivity Disorder (ADHD)
    Additional relevant MeSH terms:
    Hyperkinesis
    Attention Deficit Disorder with Hyperactivity
    Methylphenidate

    Study Results

    No Results Posted as of Jun 25, 2015