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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg | Experimental | Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg dose (one 20 mg capsule and one 10 mg capsule) orally once a day for 7 days. |
|
| Dex-Methylphenidate hydrochloride (Focalin® XR) 20 mg | Active Comparator | Dex-Methylphenidate hydrochloride (Focalin® XR) one 20 mg capsule orally once a day for 7 days. |
|
| Placebo | Placebo Comparator | Two Capsules taken 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 | 10 mg and/or 20 mg capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Pre-dose to 10, 11, and 12 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Study Center, LLC | Little Rock | Arkansas | 72205 | United States | ||
| Florida Clinical Research Center, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22926597 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: First Intervention |
|
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| Placebo | Drug | Placebo Comparator |
|
| Pre-dose to 10, 11, and 12 hours post-dose |
| 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 | 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. | Pre-dose to 10, 11, and 12 hours post-dose |
| 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 | 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. | Pre-dose to 10, 11, and 12 hours post-dose |
| 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 | 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. | Pre-dose to 10, 11, and 12 hours post-dose |
| Bradenton |
| Florida |
| 34208 |
| United States |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66212 | United States |
| Center for Psychiatry and Behavioral Medicine, Inc. | Las Vegas | Nevada | 89128 | United States |
| Bayou City Research | Houston | Texas | 77007 | United States |
| Claghorn-Lesem Research Clinic | Houston | Texas | 77008 | United States |
| Behavioral Neurology | Lubbock | Texas | 79423 | United States |
| 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. |
| FG002 | 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 . |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2: Second Intervention |
|
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| Period 3: Third Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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 . |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | 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 | Posted | Least Squares Mean | Standard Error | Scores on a scale | Pre-dose to 10, 11, and 12 hours post-dose |
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| Secondary | 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 | 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. | 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 | Posted | Least Squares Mean | Standard Error | Scores on a scale | Pre-dose to 10, 11, and 12 hours post-dose |
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| Secondary | 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 | 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. | 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 | Posted | Least Squares Mean | Standard Error | Scores on a scale | Pre-dose to 10, 11, and 12 hours post-dose |
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| Secondary | 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 | 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. | 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 | Posted | Least Squares Mean | Standard Error | Number attempted | Pre-dose to 10, 11, and 12 hours post-dose |
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| Secondary | 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 | 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. | 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. | Posted | Least Squares Mean | Standard Error | Number correct | Pre-dose to 10, 11, and 12 hours 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) 30 mg | 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. | 0 | 165 | 10 | 165 | ||
| EG001 | Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg | 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. | 1 | 165 | 8 | 165 | ||
| EG002 | Placebo | Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence. | 0 | 165 | 0 | 165 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peritonsillar abscess | Infections and infestations | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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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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| Protocol Violation |
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| Male |
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| OG002 | Placebo | Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence. |
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| OG002 | Placebo | Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence. |
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| OG002 | Placebo | Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence. |
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| OG002 | Placebo | Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence. |
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