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Efficacy and Safety of Dex-Methylphenidate Extended Release 30 mg Versus 20 mg in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting.

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00776009
First received: October 16, 2008
Last updated: June 6, 2011
Last verified: June 2011

October 16, 2008
June 6, 2011
October 2008
December 2008   (final data collection date for primary outcome measure)
Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Combined Attention and Deportment Scores at 10, 11, and 12 Hour (Averaged) Post-dose [ Time Frame: Pre-dose to 10, 11, and 12 hours post-dose ] [ Designated as safety issue: No ]
SKAMP is a 13-item rating scale that measures classroom manifestations of ADHD consisting of 2 subscales (7 items for Attention and 6 items for Deportment) used to generate a score at Hours 10, 11 and 12 on Day 7 of Weeks 1, 2 and 3. The ratings were based on both frequency and quality of specific behaviors. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78. The reported measure is the difference from baseline of the 2 combined subscores averaged over Hours 10, 11 and 12. A negative score indicates improvement.
To evaluate the change in the Swanson, Kotkin, Agler, M Flynn and Pelham (SKAMP) combined, Attention and Deportment scores at 10, 11 and 12 hour time points (post-dose). [ Time Frame: 10, 11 and 12 hour time points (post dose) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00776009 on ClinicalTrials.gov Archive Site
  • Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Attention Score at 10, 11, and 12 Hour (Averaged) Post-dose [ Time Frame: Pre-dose to 10, 11, and 12 hours post-dose ] [ Designated as safety issue: No ]
    SKAMP is a 13-item rating scale consisting of 2 subscales (7-items for Attention and 6-items for Deportment) that measures classroom manifestations of ADHD. SKAMP was used to generate a score on the Attention subscale at Hours 10, 11, and 12 on Day 7 of Weeks 1, 2, and 3. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 42 for the Attention subscale. The reported measure is the difference from baseline of the subscore averaged over Hours 10, 11, and 12. A negative score indicates improvement.
  • Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Deportment Score at 10, 11, and 12 Hour (Averaged) Post-dose [ Time Frame: Pre-dose to 10, 11, and 12 hours post-dose ] [ Designated as safety issue: No ]
    SKAMP is a 13-item rating scale consisting of 2 subscales (7-items for Attention and 6-items for Deportment) that measures classroom manifestations of ADHD. SKAMP was used to generate a score on the Deportment subscale at Hours 10, 11, and 12 on Day 7 of Weeks 1, 2, and 3. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 36 for the Deportment subscale. The reported measure is the difference from baseline of the subscore averaged over Hours 10, 11, and 12. A negative score indicates improvement.
  • Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Attempted Score at 10, 11, and 12 Hours (Averaged) Post-dose [ Time Frame: Pre-dose to 10, 11, and 12 hours post-dose ] [ Designated as safety issue: No ]
    Permanent Product Measure of Performance of Measurement (PERMP) is an age-adjusted, paper-and-pencil math test consisting of 5 pages of 80 math problems each presented in ascending order of difficulty (requiring addition, subtraction, multiplication, and division computations, respectively) during a 10-minute time period. At the end of the 10-minute math test, papers are collected and scored; the number of problems attempted and the number of problems correctly answered are generated as objective measures related to "academic productivity." A positive score indicates improvement.
  • Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Correctly Answered Score at 10, 11, and 12 Hours (Averaged) Post-dose [ Time Frame: Pre-dose to 10, 11, and 12 hours post-dose ] [ Designated as safety issue: No ]
    Permanent Product Measure of Performance of Measurement (PERMP) is an age-adjusted, paper-and-pencil math test consisting of 5 pages of 80 math problems each presented in ascending order of difficulty (requiring addition, subtraction, multiplication, and division computations, respectively) during a 10-minute time period. At the end of the 10-minute math test, papers are collected and scored; the number of problems attempted and the number of problems correctly answered are generated as objective measures related to "academic productivity." A positive score indicates improvement.
  • To evaluate the change in the Swanson, Kotkin, Agler, M Flynn and Pelham (SKAMP) combined, Attention and Deportment scores at 3, 6, 9, 10, 11 and 12 hour time points (post-dose). [ Time Frame: 3, 6, 9, 10, 11 and 12 hour time points (post-dose) ] [ Designated as safety issue: No ]
  • To evaluate the efficacy of Dex-Methylphenidate as measured by the Product Measure of Performance (math test) at hours 3, 6, 9, 10, 11 and 12 post-dose. [ Time Frame: Hours 3, 6, 9, 10, 11 and 12 post-dose ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of Dex-Methylphenidate Extended Release 30 mg Versus 20 mg in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting.
A Randomized, Multi-center, Double-blind, Placebo-controlled, Cross-over Study Evaluating the Safety and Efficacy of Dex-Methylphenidate Extended Release 30 mg vs. 20 mg as Measured by SKAMP-Combined Scores in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting.

This study will evaluate the efficacy and safety of Dex-Methylphenidate Extended Release 30 mg compared to 20 mg in pediatric patients ages 6-12 with Attention-Deficit Hyperactivity Disorder (ADHD) in a 12-hour laboratory classroom setting.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Attention-Deficit/Hyperactivity Disorder (ADHD)
  • Drug: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)
    10 mg and/or 20 mg capsules
  • Drug: Placebo
    Placebo Comparator
  • Experimental: Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg
    Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg dose (one 20 mg capsule and one 10 mg capsule) orally once a day for 7 days.
    Intervention: Drug: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)
  • Active Comparator: Dex-Methylphenidate hydrochloride (Focalin® XR) 20 mg
    Dex-Methylphenidate hydrochloride (Focalin® XR) one 20 mg capsule orally once a day for 7 days.
    Intervention: Drug: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)
  • Placebo Comparator: Placebo
    Two Capsules taken orally once a day for 7 days
    Intervention: Drug: Placebo
Brams M, Turnbow J, Pestreich L, Giblin J, Childress A, McCague K, Muniz R. A randomized, double-blind study of 30 versus 20 mg dexmethylphenidate extended-release in children with attention-deficit/hyperactivity disorder: late-day symptom control. J Clin Psychopharmacol. 2012 Oct;32(5):637-44. doi: 10.1097/JCP.0b013e3182677825.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
165
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female subjects aged 6-12 years, inclusive.
  • Subjects meeting the DSM-IV criteria for primary diagnosis of ADHD-Combined type, or predominantly hyperactive-impulsive subtype, 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.

Exclusion Criteria:

  • Subject or subject's guardian unable to understand or follow instructions necessary to participate in the study.
  • Diagnosed with or history of 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 (Alanine Amino Transferase), AST (Aspartate Amino Transferase), GGT (Gamma glutamyl transferase) or serum creatinine greater then 2X the ULN (Upper Limit of Normal) 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)
  • 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

Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00776009
CRIT124EUS21
Not Provided
Study Director Novartis Pharmaceuticals, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis
Novartis
June 2011

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