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

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ClinicalTrials.gov Identifier: NCT00564954
Recruitment Status : Completed
First Posted : November 29, 2007
Results First Posted : March 30, 2009
Last Update Posted : April 27, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE November 27, 2007
First Posted Date  ICMJE November 29, 2007
Results First Submitted Date  ICMJE November 25, 2008
Results First Posted Date  ICMJE March 30, 2009
Last Update Posted Date April 27, 2012
Study Start Date  ICMJE October 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2011)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 27, 2007)
Change in The Swanson, Kotkin, Agler, M Flynn and Pelham (SKAMP) Combined score from pre-dose (0 Hour) to 0.5, 1, 2, 4, 6 and 8 hours post-dose. The primary analysis time point is 0.5 hour post-dose.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2011)
  • 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Number of math questions answered correctly within a 10 minute period.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2007)
  • Change from pre-dose in SKAMP Attention score (at all hours post-dose)
  • Change from pre-dose in SKAMP Deportment score (at all hours post-dose)
  • Change from pre-dose in Math Test-attempt scores (at all hours post-dose)
  • Change from pre-dose in Math Test-correct scores (at all hours post-dose)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Dex-methylphenidate Extended Release in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD)
Official Title  ICMJE 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
Brief Summary This study compared the efficacy of dex-methylphenidate extended release 20 mg versus placebo during an 8-hour laboratory classroom day.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Attention Deficit Hyperactivity Disorder
Intervention  ICMJE
  • Drug: Dex-methylphenidate hydrochloride extended-release (Focalin XR)
    20 mg capsule orally once a day for 7 days
    Other Name: Focalin XR
  • Drug: Placebo
    orally once a day for 7 days
Study Arms  ICMJE
  • Experimental: Dex-methylphenidate hydrochloride (Focalin XR)
    20 mg capsule orally once a day for 7 days
    Intervention: Drug: Dex-methylphenidate hydrochloride extended-release (Focalin XR)
  • Placebo Comparator: Placebo
    orally once a day for 7 days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2009)
86
Original Estimated Enrollment  ICMJE
 (submitted: November 27, 2007)
90
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00564954
Other Study ID Numbers  ICMJE CRIT124EUS19
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP