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To assess the efficacy and safety of efficacy of MTS compared to placebo
To assess the efficacy and safety of efficacy of MTS compared to placebo, as determined by the change in the clinician completed ADHD Rating Scale - Version 4th Edition (ADHD-RS-IV), in the symptomatic treatment of adolescents (aged 13-17 years) diagnosed with ADHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylphenidate Transdermal System | Experimental | dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear |
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| 2 | Placebo Comparator | Daily application of matching MTS Placebo Patch |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylphenidate transdermal system | Drug | dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint | The Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. | baseline and endpoint (up to 7 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint | The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true). | Baseline and endpoint (up to 7 weeks) |
| Improvement in Clinical Global Impressions-Improvement (CGI-I) Score |
| Measure | Description | Time Frame |
|---|---|---|
| Post Sleep Questionnaire (PSQ) Quality of Sleep | Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses. | up to 7 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert L Finding, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Melmed Center | Scottsdale | Arizona | United States | |||
| Bay Area Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20625364 | Result | Findling RL, Turnbow J, Burnside J, Melmed R, Civil R, Li Y. A randomized, double-blind, multicenter, parallel-group, placebo-controlled, dose-optimization study of the methylphenidate transdermal system for the treatment of ADHD in adolescents. CNS Spectr. 2010 Jul;15(7):419-30. doi: 10.1017/s1092852900000353. |
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217 subjects were enrolled and randomized. The study included a screening/washout period, a 5 week dose optimization period, a 2 week maintenance period, and a follow-up period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Methylphenidate Transdermal System | Methylphenidate Transdermal System Patch |
| FG001 | Placebo (PTS) | Placebo Transdermal System |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Placebo patch |
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Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale. |
| up to 7 weeks |
| Improvement in Parent Global Assessment (PGA) Score | Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale. | up to 7 weeks |
| Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint | The Youth Quality of Life Instrument-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). | Baseline and endpoint (up to 7 weeks) |
| Dermal Response Scale (DRS) Scores | Mean dermal reaction scores were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles. | up to 7 weeks |
| Change From Baseline in Electrocardiogram Results(QTcF Interval) at Endpoint | QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation. | Baseline and endpoint (up to 7 weeks) |
| Change From Baseline in Pulse Rate at Endpoint | Baseline and endpoint (up to 7 weeks) |
| Change From Baseline in Systolic Blood Pressure at Endpoint | Baseline and endpoint (up to 7 weeks) |
| Change From Baseline in Diastolic Blood Pressure at Endpoint | Baseline and endpoint (up to 7 weeks) |
| Change From Baseline in Weight at Endpoint | Baseline and endpoint (up to 7 weeks) |
| Lafayette |
| California |
| United States |
| Elite Clinical Trials Inc. | Wildomar | California | United States |
| Sarkis Clinical Trials | Gainesville | Florida | United States |
| Miami Research Associates | South Miami | Florida | United States |
| Northwest Behavioral Research Ctr | Roswell | Georgia | United States |
| Mountain West Clinical Trials, LLC | Eagle | Idaho | United States |
| Vince and Associates Clinical Research | Overland Park | Kansas | United States |
| Shire Clinical Research Site | Lexington | Kentucky | United States |
| Four Rivers Clinical Research, Inc. | Paducah | Kentucky | United States |
| Rochester Center for Behavioral Medicine | Rochester Hills | Michigan | United States |
| Clinical Neurophysiology Services, PC | Troy | Michigan | United States |
| CRI Worldwide | Clementon | New Jersey | United States |
| Triangle Neuropsychiatry | Durham | North Carolina | United States |
| Dakota Clinic/Innovis health | Fargo | North Dakota | United States |
| Odyssey Research | Minot | North Dakota | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | United States |
| Oregon Center for Clinical Investigations, Inc. | Eugene | Oregon | United States |
| OCCI, Inc | Portland | Oregon | United States |
| Shire Clinical Research Site | Media | Pennsylvania | United States |
| CRI Worldwide | Philadelphia | Pennsylvania | United States |
| Rhode Island Hospital | Providence | Rhode Island | United States |
| CNS Healthcare | Memphis | Tennessee | United States |
| FutureSearch Trials | Austin | Texas | United States |
| Claghorn-Lesem Research, Ltd. | Bellaire | Texas | United States |
| Westex Clinical Investigations | Lubbock | Texas | United States |
| Cerebral Research, LLC | San Antonio | Texas | United States |
| Vermont Clinical Study Center | Burlington | Vermont | United States |
| NeuroScience, Inc. | Herndon | Virginia | United States |
| Adolescent Health Center | Midlothian | Virginia | United States |
| Northwest Clinical Research Center | Friday Harbor | Washington | United States |
| Eastside Therapeutic Resource | Kirkland | Washington | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Methylphenidate Transdermal System | Methylphenidate Transdermal System Patch |
| BG001 | Placebo (PTS) | Placebo Transdermal System |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint | The Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. | Intent-to-treat (ITT) which included all randomized subjects who received at least one dose of MTS or PTS, and had one Baseline and at least one post-Baseline assessment. | Posted | Least Squares Mean | Standard Error | scores on a scale | baseline and endpoint (up to 7 weeks) |
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| Secondary | Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint | The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true). | ITT | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and endpoint (up to 7 weeks) |
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| Secondary | Improvement in Clinical Global Impressions-Improvement (CGI-I) Score | Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale. | ITT | Posted | Number | Participants | up to 7 weeks |
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| Secondary | Improvement in Parent Global Assessment (PGA) Score | Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale. | ITT | Posted | Number | Participants | up to 7 weeks |
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| Secondary | Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint | The Youth Quality of Life Instrument-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). | ITT | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and endpoint (up to 7 weeks) |
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| Other Pre-specified | Post Sleep Questionnaire (PSQ) Quality of Sleep | Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses. | Safety population (Note: not everyone in the safety population completed a sleep questionnaire) | Posted | Number | Participants | up to 7 weeks |
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| Secondary | Dermal Response Scale (DRS) Scores | Mean dermal reaction scores were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles. | Safety population which included all randomized subjects that received at least one dose of MTS or PTS. | Posted | Mean | Standard Deviation | scores on a scale | up to 7 weeks |
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| Secondary | Change From Baseline in Electrocardiogram Results(QTcF Interval) at Endpoint | QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation. | Safety population | Posted | Mean | Standard Deviation | msec | Baseline and endpoint (up to 7 weeks) |
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| Secondary | Change From Baseline in Pulse Rate at Endpoint | Safety population | Posted | Mean | Standard Deviation | bpm | Baseline and endpoint (up to 7 weeks) |
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| Secondary | Change From Baseline in Systolic Blood Pressure at Endpoint | Safety population | Posted | Mean | Standard Deviation | mmHg | Baseline and endpoint (up to 7 weeks) |
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| Secondary | Change From Baseline in Diastolic Blood Pressure at Endpoint | Posted | Mean | Standard Deviation | mmHg | Baseline and endpoint (up to 7 weeks) |
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| Secondary | Change From Baseline in Weight at Endpoint | Safety population | Posted | Mean | Standard Deviation | lbs | Baseline and endpoint (up to 7 weeks) |
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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 | Methylphenidate Transdermal System | Methylphenidate Transdermal System Patch | 1 | 145 | 125 | 145 | ||
| EG001 | Placebo (PTS) | Placebo Transdermal System | 1 | 72 | 28 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| syncope | Nervous system disorders | Non-systematic Assessment |
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| negativism | Psychiatric disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
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| Weight decreased | Investigations | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | Non-systematic Assessment |
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| Irritability | Psychiatric disorders | Non-systematic Assessment |
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If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amaury Sanchez, Sr. Manager, Regulatory Affairs | Noven Pharmaceuticals, Inc. | asanchez@noven.com |
| 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 |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| 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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| >=65 years |
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| Male |
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