Trial Outcomes & Findings for A Study of Dex-methylphenidate Extended Release in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) (NCT NCT00564954)
NCT ID: NCT00564954
Last Updated: 2012-04-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
86 participants
Primary outcome timeframe
0 hr and 0.5 hr post-dose
Results posted on
2012-04-27
Participant Flow
Participant milestones
| Measure |
Dex-methylphenidate Hydrochloride (Focalin XR) Then Placebo
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.
|
Placebo Then Dex-methylphenidate Hydrochloride (Focalin XR)
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 1- 1 Week
STARTED
|
44
|
42
|
|
Period 1- 1 Week
COMPLETED
|
44
|
42
|
|
Period 1- 1 Week
NOT COMPLETED
|
0
|
0
|
|
Period 2- 1 Week
STARTED
|
44
|
42
|
|
Period 2- 1 Week
COMPLETED
|
44
|
42
|
|
Period 2- 1 Week
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Dex-methylphenidate Extended Release in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
Dex-methylphenidate Hydrochloride (Focalin XR) Then Placebo
n=44 Participants
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.
|
Placebo Then Dex-methylphenidate Hydrochloride (Focalin XR)
n=42 Participants
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
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
9.5 years
STANDARD_DEVIATION 2.0 • n=39 Participants
|
9.4 years
STANDARD_DEVIATION 1.4 • n=41 Participants
|
9.5 years
STANDARD_DEVIATION 1.7 • n=35 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
33 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
53 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 0 hr and 0.5 hr post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Dex-methylphenidate Hydrochloride (Focalin XR)
n=86 Participants
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.
|
Placebo
n=86 Participants
Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
|
|---|---|---|
|
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
|
-0.969 score on a scale
Standard Error 0.909
|
3.336 score on a scale
Standard Error 0.907
|
SECONDARY outcome
Timeframe: 0, 1, 2, 4, 6, and 8 hrPopulation: Intent to Treat (ITT) population
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.
Outcome measures
| Measure |
Dex-methylphenidate Hydrochloride (Focalin XR)
n=86 Participants
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.
|
Placebo
n=86 Participants
Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
|
|---|---|---|
|
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)
1 hour
|
-6.358 score on a scale
Standard Error 0.993
|
5.670 score on a scale
Standard Error 0.991
|
|
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)
2 hours
|
-11.573 score on a scale
Standard Error 0.856
|
5.467 score on a scale
Standard Error 0.854
|
|
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)
4 hours
|
-11.395 score on a scale
Standard Error 0.847
|
3.925 score on a scale
Standard Error 0.844
|
|
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)
6 hours
|
-10.622 score on a scale
Standard Error 0.950
|
5.346 score on a scale
Standard Error 0.952
|
|
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)
8 hours
|
-10.260 score on a scale
Standard Error 0.988
|
3.621 score on a scale
Standard Error 0.986
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 4, 6, and 8 hoursPopulation: Intent to Treat (ITT) population
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.
Outcome measures
| Measure |
Dex-methylphenidate Hydrochloride (Focalin XR)
n=86 Participants
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.
|
Placebo
n=86 Participants
Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
|
|---|---|---|
|
Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8)
0.5 hour
|
-0.825 score on a scale
Standard Error 0.524
|
0.862 score on a scale
Standard Error 0.520
|
|
Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8)
1 hour
|
-4.208 score on a scale
Standard Error 0.589
|
2.304 score on a scale
Standard Error 0.584
|
|
Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8)
2 hours
|
-6.591 score on a scale
Standard Error 0.507
|
2.465 score on a scale
Standard Error 0.504
|
|
Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8)
4 hours
|
-6.722 score on a scale
Standard Error 0.506
|
1.183 score on a scale
Standard Error 0.503
|
|
Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8)
6 hours
|
-5.819 score on a scale
Standard Error 0.582
|
2.715 score on a scale
Standard Error 0.580
|
|
Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8)
8 hours
|
-6.061 score on a scale
Standard Error 0.584
|
1.415 score on a scale
Standard Error 0.580
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 4, 6 and 8 hoursPopulation: Intent to Treat (ITT) population.
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.
Outcome measures
| Measure |
Dex-methylphenidate Hydrochloride (Focalin XR)
n=86 Participants
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.
|
Placebo
n=86 Participants
Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
|
|---|---|---|
|
Change From Pre-dose in SKAMP Deportment Score
0.5 hour
|
0.127 score on a scale
Standard Error 0.550
|
2.226 score on a scale
Standard Error 0.550
|
|
Change From Pre-dose in SKAMP Deportment Score
1 hour
|
-1.863 score on a scale
Standard Error 0.564
|
3.103 score on a scale
Standard Error 0.564
|
|
Change From Pre-dose in SKAMP Deportment Score
2 hours
|
-4.850 score on a scale
Standard Error 0.499
|
2.881 score on a scale
Standard Error 0.499
|
|
Change From Pre-dose in SKAMP Deportment Score
4 hours
|
-4.420 score on a scale
Standard Error 0.526
|
2.511 score on a scale
Standard Error 0.526
|
|
Change From Pre-dose in SKAMP Deportment Score
6 hours
|
-4.614 score on a scale
Standard Error 0.541
|
2.393 score on a scale
Standard Error 0.541
|
|
Change From Pre-dose in SKAMP Deportment Score
8 hours
|
-3.939 score on a scale
Standard Error 0.560
|
1.969 score on a scale
Standard Error 0.560
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 4, 6 and 8 hoursPopulation: Intent to Treat (ITT) population
Number of math questions attempted within a 10 minute period.
Outcome measures
| Measure |
Dex-methylphenidate Hydrochloride (Focalin XR)
n=86 Participants
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.
|
Placebo
n=86 Participants
Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
|
|---|---|---|
|
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)
0.5 hour
|
6.93 questions attempted
Standard Error 2.96
|
-4.74 questions attempted
Standard Error 2.96
|
|
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)
1 hour
|
33.26 questions attempted
Standard Error 3.66
|
-12.18 questions attempted
Standard Error 3.66
|
|
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)
2 hours
|
45.52 questions attempted
Standard Error 3.61
|
-10.19 questions attempted
Standard Error 3.61
|
|
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)
4 hours
|
45.01 questions attempted
Standard Error 3.60
|
-7.42 questions attempted
Standard Error 3.60
|
|
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)
6 hours
|
37.33 questions attempted
Standard Error 3.82
|
-16.70 questions attempted
Standard Error 3.84
|
|
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)
8 hours
|
44.04 questions attempted
Standard Error 3.50
|
-10.08 questions attempted
Standard Error 3.50
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 4, 6 and 8 hoursPopulation: Intent to Treat (ITT) population.
Number of math questions answered correctly within a 10 minute period.
Outcome measures
| Measure |
Dex-methylphenidate Hydrochloride (Focalin XR)
n=86 Participants
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.
|
Placebo
n=86 Participants
Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
|
|---|---|---|
|
Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test
0.5 hour
|
7.10 questions correct
Standard Error 2.72
|
-5.96 questions correct
Standard Error 2.72
|
|
Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test
1 hour
|
31.10 questions correct
Standard Error 3.34
|
-13.21 questions correct
Standard Error 3.34
|
|
Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test
2 hours
|
44.92 questions correct
Standard Error 3.44
|
-11.09 questions correct
Standard Error 3.44
|
|
Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test
4 hours
|
43.64 questions correct
Standard Error 3.37
|
-7.52 questions correct
Standard Error 3.37
|
|
Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test
6 hours
|
37.78 questions correct
Standard Error 3.55
|
-16.90 questions correct
Standard Error 3.57
|
|
Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test
8 hours
|
43.37 questions correct
Standard Error 3.40
|
-11.44 questions correct
Standard Error 3.40
|
Adverse Events
Dex-methylphenidate Hydrochloride (Focalin XR)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER