Trial Outcomes & Findings for 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. (NCT NCT00776009)
NCT ID: NCT00776009
Last Updated: 2011-06-08
Results Overview
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.
COMPLETED
PHASE4
165 participants
Pre-dose to 10, 11, and 12 hours post-dose
2011-06-08
Participant Flow
Participant milestones
| Measure |
Focalin XR 20 mg First, Then Focalin XR 30 mg, Then Placebo
Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days.
|
Focalin XR 30 mg First, Then Placebo, Then Focalin XR 20 mg
Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
|
Focalin XR 30 mg First, Then Focalin XR 20 mg, Then Placebo
Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days .
|
Placebo First, Then Focalin XR 20 mg, Then Focalin XR 30 mg
Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
|
Focalin XR 20 mg First, Then Placebo, Then Focalin XR 30 mg
Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
|
Placebo First, Then Focalin XR 30 mg, Then Focalin XR 20 mg
Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
|
|---|---|---|---|---|---|---|
|
Period 1: First Intervention
STARTED
|
26
|
28
|
29
|
27
|
28
|
27
|
|
Period 1: First Intervention
COMPLETED
|
26
|
27
|
28
|
27
|
26
|
27
|
|
Period 1: First Intervention
NOT COMPLETED
|
0
|
1
|
1
|
0
|
2
|
0
|
|
Period 2: Second Intervention
STARTED
|
26
|
27
|
28
|
27
|
26
|
27
|
|
Period 2: Second Intervention
COMPLETED
|
25
|
27
|
27
|
27
|
26
|
26
|
|
Period 2: Second Intervention
NOT COMPLETED
|
1
|
0
|
1
|
0
|
0
|
1
|
|
Period 3: Third Intervention
STARTED
|
25
|
27
|
27
|
27
|
26
|
26
|
|
Period 3: Third Intervention
COMPLETED
|
24
|
27
|
27
|
27
|
26
|
26
|
|
Period 3: Third Intervention
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Focalin XR 20 mg First, Then Focalin XR 30 mg, Then Placebo
Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days.
|
Focalin XR 30 mg First, Then Placebo, Then Focalin XR 20 mg
Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
|
Focalin XR 30 mg First, Then Focalin XR 20 mg, Then Placebo
Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days .
|
Placebo First, Then Focalin XR 20 mg, Then Focalin XR 30 mg
Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
|
Focalin XR 20 mg First, Then Placebo, Then Focalin XR 30 mg
Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
|
Placebo First, Then Focalin XR 30 mg, Then Focalin XR 20 mg
Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
|
|---|---|---|---|---|---|---|
|
Period 1: First Intervention
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Period 1: First Intervention
Protocol Violation
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Period 2: Second Intervention
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Period 2: Second Intervention
Protocol Violation
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Period 3: Third Intervention
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Focalin XR 20 mg First, Then Focalin XR 30 mg, Then Placebo
n=26 Participants
Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days.
|
Focalin XR 30 mg First, Then Placebo, Then Focalin XR 20 mg
n=28 Participants
Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
|
Focalin XR 30 mg First, Then Focalin XR 20 mg, Then Placebo
n=29 Participants
Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days .
|
Placebo First, Then Focalin XR 20 mg, Then Focalin XR 30 mg
n=27 Participants
Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
|
Focalin XR 20 mg First, Then Placebo, Then Focalin XR 30 mg
n=28 Participants
Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
|
Placebo First, Then Focalin XR 30 mg, Then Focalin XR 20 mg
n=27 Participants
Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age Continuous
|
9.3 Years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
9.4 Years
STANDARD_DEVIATION 1.7 • n=7 Participants
|
10.0 Years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
9.4 Years
STANDARD_DEVIATION 2.0 • n=4 Participants
|
9.5 Years
STANDARD_DEVIATION 1.8 • n=21 Participants
|
9.6 Years
STANDARD_DEVIATION 2.0 • n=8 Participants
|
9.6 Years
STANDARD_DEVIATION 1.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
71 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
94 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
28 participants
n=7 Participants
|
29 participants
n=5 Participants
|
27 participants
n=4 Participants
|
28 participants
n=21 Participants
|
27 participants
n=8 Participants
|
165 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Pre-dose to 10, 11, and 12 hours post-dosePopulation: Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement
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.
Outcome measures
| Measure |
Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg
n=159 Participants
Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
|
Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg
n=158 Participants
Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
|
Placebo
n=158 Participants
Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
|
|---|---|---|---|
|
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
|
-2.02 Scores on a scale
Standard Error 0.717
|
-4.47 Scores on a scale
Standard Error 0.724
|
4.50 Scores on a scale
Standard Error .723
|
SECONDARY outcome
Timeframe: Pre-dose to 10, 11, and 12 hours post-dosePopulation: Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement
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.
Outcome measures
| Measure |
Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg
n=159 Participants
Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
|
Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg
n=158 Participants
Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
|
Placebo
n=158 Participants
Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
|
|---|---|---|---|
|
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
|
-1.33 Scores on a scale
Standard Error 0.397
|
-2.62 Scores on a scale
Standard Error 0.400
|
0.94 Scores on a scale
Standard Error 0.405
|
SECONDARY outcome
Timeframe: Pre-dose to 10, 11, and 12 hours post-dosePopulation: Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement
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.
Outcome measures
| Measure |
Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg
n=159 Participants
Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
|
Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg
n=158 Participants
Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
|
Placebo
n=158 Participants
Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
|
|---|---|---|---|
|
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
|
-0.39 Scores on a scale
Standard Error 0.423
|
-1.49 Scores on a scale
Standard Error 0.426
|
2.95 Scores on a scale
Standard Error 0.424
|
SECONDARY outcome
Timeframe: Pre-dose to 10, 11, and 12 hours post-dosePopulation: Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement
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.
Outcome measures
| Measure |
Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg
n=159 Participants
Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
|
Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg
n=157 Participants
Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
|
Placebo
n=157 Participants
Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
|
|---|---|---|---|
|
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
|
18.76 Number attempted
Standard Error 3.065
|
28.03 Number attempted
Standard Error 3.078
|
-0.23 Number attempted
Standard Error 3.073
|
SECONDARY outcome
Timeframe: Pre-dose to 10, 11, and 12 hours post-dosePopulation: Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement.
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.
Outcome measures
| Measure |
Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg
n=159 Participants
Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
|
Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg
n=157 Participants
Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
|
Placebo
n=157 Participants
Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
|
|---|---|---|---|
|
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
|
18.45 Number correct
Standard Error 2.461
|
28.02 Number correct
Standard Error 2.480
|
-4.30 Number correct
Standard Error 2.474
|
Adverse Events
Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg
Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg
Placebo
Serious adverse events
| Measure |
Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg
n=165 participants at risk
Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
|
Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg
n=165 participants at risk
Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
|
Placebo
n=165 participants at risk
Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
|
|---|---|---|---|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/165
|
0.61%
1/165
|
0.00%
0/165
|
Other adverse events
| Measure |
Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg
n=165 participants at risk
Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
|
Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg
n=165 participants at risk
Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
|
Placebo
n=165 participants at risk
Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.1%
10/165
|
4.8%
8/165
|
0.00%
0/165
|
Additional Information
Study Director
Novartis Pharmaceuticals
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