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This study compared the efficacy of dex-methylphenidate extended release 20 mg versus placebo during an 8-hour laboratory classroom day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dex-methylphenidate hydrochloride (Focalin XR) | Experimental | 20 mg capsule orally once a day for 7 days |
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| Placebo | Placebo Comparator | orally once a day for 7 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dex-methylphenidate hydrochloride extended-release (Focalin XR) | Drug | 20 mg capsule orally once a day for 7 days |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 0 hr and 0.5 hr post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | 0, 1, 2, 4, 6, and 8 hr |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Little Rock | Arkansas | 72205 | United States | ||
| Novartis Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo Then Dex-methylphenidate Hydrochloride (Focalin XR) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1- 1 Week |
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| Placebo | Drug | orally once a day for 7 days |
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| Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8) | 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. | 0, 0.5, 1, 2, 4, 6, and 8 hours |
| Change From Pre-dose in SKAMP Deportment Score | 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. | 0, 0.5, 1, 2, 4, 6 and 8 hours |
| 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) | Number of math questions attempted within a 10 minute period. | 0, 0.5, 1, 2, 4, 6 and 8 hours |
| Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test | Number of math questions answered correctly within a 10 minute period. | 0, 0.5, 1, 2, 4, 6 and 8 hours |
| Winter Park |
| Florida |
| 32792 |
| United States |
| Novartis Investigative Site | Las Vegas | Nevada | 89128 | United States |
| Novartis Investigative Site | Houston | Texas | 77007 | United States |
| Novartis Investigative Site | Lubbock | Texas | 79423 | United States |
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. |
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| NOT COMPLETED |
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| Period 2- 1 Week |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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) | 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. | Intent to Treat (ITT) population | Posted | Least Squares Mean | Standard Error | score on a scale | 0, 1, 2, 4, 6, and 8 hr |
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| Secondary | Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8) | 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. | Intent to Treat (ITT) population | Posted | Least Squares Mean | Standard Error | score on a scale | 0, 0.5, 1, 2, 4, 6, and 8 hours |
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| Secondary | Change From Pre-dose in SKAMP Deportment Score | 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. | Intent to Treat (ITT) population. | Posted | Least Squares Mean | Standard Error | score on a scale | 0, 0.5, 1, 2, 4, 6 and 8 hours |
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| Secondary | 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) | Number of math questions attempted within a 10 minute period. | Intent to Treat (ITT) population | Posted | Least Squares Mean | Standard Error | questions attempted | 0, 0.5, 1, 2, 4, 6 and 8 hours |
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| Secondary | Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test | Number of math questions answered correctly within a 10 minute period. | Intent to Treat (ITT) population. | Posted | Least Squares Mean | Standard Error | questions correct | 0, 0.5, 1, 2, 4, 6 and 8 hours |
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| Primary | 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 | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 0 hr and 0.5 hr post-dose |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dex-methylphenidate Hydrochloride (Focalin XR) | 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. | 0 | 86 | 0 | 86 | ||
| EG001 | Placebo | Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence. | 0 | 86 | 0 | 86 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D064699 | Dexmethylphenidate Hydrochloride |
| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| 4 hours |
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| 6 hours |
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| 8 hours |
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