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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 )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Interventions Drug: Dex-methylphenidate hydrochloride extended-release (Focalin XR)
Drug: Placebo
Enrollment 86
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dex-methylphenidate Hydrochloride (Focalin XR) Then Placebo Placebo Then Dex-methylphenidate Hydrochloride (Focalin XR)
Hide Arm/Group Description Period 1: One 20 mg capsule of Focalin XR taken once daily in the morning for one week followed by Period 2: one week of placebo taken once daily in the morning. Period 1: One week of placebo taken once daily in the morning followed by Period 2: one week of one 20 mg capsule of Focalin XR taken once daily in the morning.
Period Title: Period 1- 1 Week
Started 44 42
Completed 44 42
Not Completed 0 0
Period Title: Period 2- 1 Week
Started 44 42
Completed 44 42
Not Completed 0 0
Arm/Group Title Dex-methylphenidate Hydrochloride (Focalin XR) Then Placebo Placebo Then Dex-methylphenidate Hydrochloride (Focalin XR) Total
Hide Arm/Group Description Period 1: One 20 mg capsule of Focalin XR taken once daily in the morning for one week followed by Period 2: one week of placebo taken once daily in the morning. Period 1: One week of placebo taken once daily in the morning followed by Period 2: one week of one 20 mg capsule of Focalin XR taken once daily in the morning. Total of all reporting groups
Overall Number of Baseline Participants 44 42 86
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 42 participants 86 participants
9.5  (2.0) 9.4  (1.4) 9.5  (1.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 42 participants 86 participants
Female
16
  36.4%
17
  40.5%
33
  38.4%
Male
28
  63.6%
25
  59.5%
53
  61.6%
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame 0 hr and 0.5 hr post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population: All randomized patients who had at least one dose of study medication and who had at least one post-dose efficacy measurement.
Arm/Group Title Dex-methylphenidate Hydrochloride (Focalin XR) Placebo
Hide Arm/Group Description:
Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
Overall Number of Participants Analyzed 86 86
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.969  (0.909) 3.336  (0.907)
2.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame 0, 1, 2, 4, 6, and 8 hr
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population
Arm/Group Title Dex-methylphenidate Hydrochloride (Focalin XR) Placebo
Hide Arm/Group Description:
Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
Overall Number of Participants Analyzed 86 86
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
1 hour -6.358  (0.993) 5.670  (0.991)
2 hours -11.573  (0.856) 5.467  (0.854)
4 hours -11.395  (0.847) 3.925  (0.844)
6 hours -10.622  (0.950) 5.346  (0.952)
8 hours -10.260  (0.988) 3.621  (0.986)
3.Secondary Outcome
Title Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8)
Hide Description 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.
Time Frame 0, 0.5, 1, 2, 4, 6, and 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population
Arm/Group Title Dex-methylphenidate Hydrochloride (Focalin XR) Placebo
Hide Arm/Group Description:
Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
Overall Number of Participants Analyzed 86 86
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.5 hour -0.825  (0.524) 0.862  (0.520)
1 hour -4.208  (0.589) 2.304  (0.584)
2 hours -6.591  (0.507) 2.465  (0.504)
4 hours -6.722  (0.506) 1.183  (0.503)
6 hours -5.819  (0.582) 2.715  (0.580)
8 hours -6.061  (0.584) 1.415  (0.580)
4.Secondary Outcome
Title Change From Pre-dose in SKAMP Deportment Score
Hide Description 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.
Time Frame 0, 0.5, 1, 2, 4, 6 and 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population.
Arm/Group Title Dex-methylphenidate Hydrochloride (Focalin XR) Placebo
Hide Arm/Group Description:
Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
Overall Number of Participants Analyzed 86 86
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.5 hour 0.127  (0.550) 2.226  (0.550)
1 hour -1.863  (0.564) 3.103  (0.564)
2 hours -4.850  (0.499) 2.881  (0.499)
4 hours -4.420  (0.526) 2.511  (0.526)
6 hours -4.614  (0.541) 2.393  (0.541)
8 hours -3.939  (0.560) 1.969  (0.560)
5.Secondary Outcome
Title 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)
Hide Description Number of math questions attempted within a 10 minute period.
Time Frame 0, 0.5, 1, 2, 4, 6 and 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population
Arm/Group Title Dex-methylphenidate Hydrochloride (Focalin XR) Placebo
Hide Arm/Group Description:
Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
Overall Number of Participants Analyzed 86 86
Least Squares Mean (Standard Error)
Unit of Measure: questions attempted
0.5 hour 6.93  (2.96) -4.74  (2.96)
1 hour 33.26  (3.66) -12.18  (3.66)
2 hours 45.52  (3.61) -10.19  (3.61)
4 hours 45.01  (3.60) -7.42  (3.60)
6 hours 37.33  (3.82) -16.70  (3.84)
8 hours 44.04  (3.50) -10.08  (3.50)
6.Secondary Outcome
Title Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test
Hide Description Number of math questions answered correctly within a 10 minute period.
Time Frame 0, 0.5, 1, 2, 4, 6 and 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population.
Arm/Group Title Dex-methylphenidate Hydrochloride (Focalin XR) Placebo
Hide Arm/Group Description:
Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
Overall Number of Participants Analyzed 86 86
Least Squares Mean (Standard Error)
Unit of Measure: questions correct
0.5 hour 7.10  (2.72) -5.96  (2.72)
1 hour 31.10  (3.34) -13.21  (3.34)
2 hours 44.92  (3.44) -11.09  (3.44)
4 hours 43.64  (3.37) -7.52  (3.37)
6 hours 37.78  (3.55) -16.90  (3.57)
8 hours 43.37  (3.40) -11.44  (3.40)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dex-methylphenidate Hydrochloride (Focalin XR) Placebo
Hide Arm/Group Description Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence. Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
All-Cause Mortality
Dex-methylphenidate Hydrochloride (Focalin XR) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Dex-methylphenidate Hydrochloride (Focalin XR) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/86 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dex-methylphenidate Hydrochloride (Focalin XR) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/86 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary; however, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00564954    
Other Study ID Numbers: CRIT124EUS19
First Submitted: November 27, 2007
First Posted: November 29, 2007
Results First Submitted: November 25, 2008
Results First Posted: March 30, 2009
Last Update Posted: April 27, 2012