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

This study has been completed.
Sponsor:
Collaborator:
Noven Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Noven Therapeutics
ClinicalTrials.gov Identifier:
NCT00151970
First received: September 7, 2005
Last updated: July 8, 2015
Last verified: July 2015
  Purpose

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 Intervention Phase
Attention Deficit Disorder With Hyperactivity
Drug: Methylphenidate Transdermal System
Drug: Placebo
Drug: Concerta
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Noven Therapeutics:

Primary Outcome Measures:
  • SKAMP deportment rating scale [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PERMP age-adjusted math test [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Clinician-rated ADHD-RS-IV [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • CGI-I [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Parent Global Assessment [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Connors' Parent Rating Scale [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • ADHD Impact Module-Children [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • SKAMP-total and inattention subscales [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: June 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Methylphenidate HCL

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Noven Therapeutics
ClinicalTrials.gov Identifier: NCT00151970     History of Changes
Other Study ID Numbers: SPD485-304
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 August 26, 2015