A Study of Dex-methylphenidate Extended Release in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00564954
First received: November 27, 2007
Last updated: April 20, 2012
Last verified: April 2012
  Purpose

This study compared the efficacy of dex-methylphenidate extended release 20 mg versus placebo during an 8-hour laboratory classroom day.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: Dex-methylphenidate hydrochloride extended-release (Focalin XR)
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-center, Double-blind, Cross-over Study Comparing the Efficacy and Safety of Focalin® XR 20 mg Versus Placebo at the 0.5 Hour Timepoint (Post-dose) in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Pre-dose (0 hr [Hour]) on the Swanson, Kotkin, Agler, M-Flynn & Pelham (SKAMP) Rating Scale Combined Score at 0.5 Hour During the 8- Hour Laboratory Classroom Day [ Time Frame: 0 hr and 0.5 hr post-dose ] [ Designated as safety issue: No ]
    SKAMP rating scale is comprised of 13 questions (7 questions on attention and 6 questions on deportment) evaluating classroom behavior; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78.


Secondary Outcome Measures:
  • Change From Pre-dose (0 hr) in SKAMP Combined Score at All Times Excluding the 0.5 Hour Timepoint (Hours 1, 2, 4, 6, 8) [ Time Frame: 0, 1, 2, 4, 6, and 8 hr ] [ Designated as safety issue: No ]
    SKAMP rating scale is comprised of 13 questions (7 questions on attention and 6 questions on deportment) evaluating classroom behavior; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78.

  • Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8) [ Time Frame: 0, 0.5, 1, 2, 4, 6, and 8 hours ] [ Designated as safety issue: No ]
    SKAMP attention sub-scale is comprised of 7 questions evaluating concentration in the classroom; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 42.

  • Change From Pre-dose in SKAMP Deportment Score [ Time Frame: 0, 0.5, 1, 2, 4, 6 and 8 hours ] [ Designated as safety issue: No ]
    SKAMP deportment sub-scale is comprised of 6 questions on behavior in the classroom; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 36.

  • Change From Pre-dose (0 hr.) in Permanent Product Measure of Performance (PERMP) Math Test-Attempted Scores at All Timepoints (0.5, 1, 2, 4, 6, 8) [ Time Frame: 0, 0.5, 1, 2, 4, 6 and 8 hours ] [ Designated as safety issue: No ]
    Number of math questions attempted within a 10 minute period.

  • Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test [ Time Frame: 0, 0.5, 1, 2, 4, 6 and 8 hours ] [ Designated as safety issue: No ]
    Number of math questions answered correctly within a 10 minute period.


Enrollment: 86
Study Start Date: October 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dex-methylphenidate hydrochloride (Focalin XR)
20 mg capsule orally once a day for 7 days
Drug: Dex-methylphenidate hydrochloride extended-release (Focalin XR)
20 mg capsule orally once a day for 7 days
Other Name: Focalin XR
Placebo Comparator: Placebo
orally once a day for 7 days
Drug: Placebo
orally once a day for 7 days

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects aged 6-12 years, inclusive.
  • Subjects meeting the DSM-IV criteria for ADHD of any type, as established by the K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version). If a DSM-IV-defined ADHD diagnosis is difficult to establish due to possible co-morbidity, the subject will not be enrolled into the study.
  • Subjects should be on a stabilized total daily dose or nearest equivalent of 40-60 mg methylphenidate or 20-30 mg of d-methylphenidate for at least two weeks prior to screening visit (Concerta® 36 mg and 54 mg is allowable)

Exclusion Criteria:

  • Parent or guardian unable or unwilling to complete the Conner's ADHD/DSM-IV Scale for Parents (CADS-P) and the Daily Diary Card
  • Diagnosed with a tic disorder or Tourette's syndrome
  • History of seizure disorder
  • The presence of a known medical condition that would preclude the use of methylphenidate. A history (within the past year) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurological disease
  • ALT, AST, GGPT or serum creatinine greater then 2X the ULN at Screening
  • A history of psychiatric illness or substance use disorder (e.g., schizophrenia, bipolar disorder, autism, abuse or dependence, depression, severe Conduct Disorder or severe Oppositional defiant disorder)
  • Subjects who have participated in an investigational trial within the past 4 weeks (28 days) are excluded
  • Subjects who are currently taking antidepressants or other psychotropic medication
  • Subjects who have initiated psychotherapy during the three months prior to randomization
  • Subjects with a positive urine drug screen
  • Subjects who have a history of poor response or intolerance to methylphenidate or d-methylphenidate

Other protocol defined inclusion/exclusion criteria may apply

  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564954

Locations
United States, Arkansas
Novartis Investigative Site
Little Rock, Arkansas, United States, 72205
United States, Florida
Novartis Investigative Site
Winter Park, Florida, United States, 32792
United States, Nevada
Novartis Investigative Site
Las Vegas, Nevada, United States, 89128
United States, Texas
Novartis Investigative Site
Houston, Texas, United States, 77007
Novartis Investigative Site
Lubbock, Texas, United States, 79423
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00564954     History of Changes
Other Study ID Numbers: CRIT124EUS19
Study First Received: November 27, 2007
Results First Received: November 25, 2008
Last Updated: April 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
ADHD
children
laboratory classroom
Attention Deficit Hyperactivity Disorder

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Dexmethylphenidate
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 October 29, 2014