Trial · NCT00499863
Evaluate the Efficacy &Safety of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD
NCT00499863, Phase 3, Completed, Noven Therapeutics; results first posted 2009-06-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluate the Efficacy &Safety of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD. Trials, record NCT00499863. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00499863
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate the Efficacy &Safety of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD
- NCT number
- NCT00499863
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 217 participants, actual
- Lead sponsor
- Noven Therapeutics
- Conditions
- ADHD
- Interventions
- methylphenidate transdermal system, Placebo
- First posted
- 2007-07-12
- Last updated
- 2017-04-26
- Results first posted
- 2009-06-11
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint | baseline and endpoint (up to 7 weeks) | 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. |
| Secondary | Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint | Baseline and endpoint (up to 7 weeks) | 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). |
| Secondary | Improvement in Clinical Global Impressions-Improvement (CGI-I) Score | up to 7 weeks | 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. |
| Secondary | Improvement in Parent Global Assessment (PGA) Score | up to 7 weeks | 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. |
| Secondary | Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint | Baseline and endpoint (up to 7 weeks) | 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). |
| Secondary | Dermal Response Scale (DRS) Scores | up to 7 weeks | 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. |
| Secondary | Change From Baseline in Electrocardiogram Results(QTcF Interval) at Endpoint | Baseline and endpoint (up to 7 weeks) | 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. |
| Secondary | Change From Baseline in Pulse Rate at Endpoint | Baseline and endpoint (up to 7 weeks) | |
| Secondary | Change From Baseline in Systolic Blood Pressure at Endpoint | Baseline and endpoint (up to 7 weeks) | |
| Secondary | Change From Baseline in Diastolic Blood Pressure at Endpoint | Baseline and endpoint (up to 7 weeks) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint | baseline and endpoint (up to 7 weeks) | 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. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint | Baseline and endpoint (up to 7 weeks) | ITT | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Improvement in Clinical Global Impressions-Improvement (CGI-I) Score | up to 7 weeks | ITT | Participants | NUMBER |
| SECONDARY | Improvement in Parent Global Assessment (PGA) Score | up to 7 weeks | ITT | Participants | NUMBER |
| SECONDARY | Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint | Baseline and endpoint (up to 7 weeks) | ITT | scores on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Post Sleep Questionnaire (PSQ) Quality of Sleep | up to 7 weeks | Safety population (Note: not everyone in the safety population completed a sleep questionnaire) | Participants | NUMBER |
| SECONDARY | Dermal Response Scale (DRS) Scores | up to 7 weeks | Safety population which included all randomized subjects that received at least one dose of MTS or PTS. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Electrocardiogram Results(QTcF Interval) at Endpoint | Baseline and endpoint (up to 7 weeks) | Safety population | msec | MEAN |
| SECONDARY | Change From Baseline in Pulse Rate at Endpoint | Baseline and endpoint (up to 7 weeks) | Safety population | bpm | MEAN |
| SECONDARY | Change From Baseline in Systolic Blood Pressure at Endpoint | Baseline and endpoint (up to 7 weeks) | Safety population | mmHg | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint | Methylphenidate Transdermal System | -18.8 | Standard Error 1.01 | scores on a scale | |
| Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint | Placebo (PTS) | -8.8 | Standard Error 1.42 | scores on a scale | |
| Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint | Methylphenidate Transdermal System | -20.9 | Standard Error 1.45 | scores on a scale | |
| Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint | Placebo (PTS) | -7.5 | Standard Error 2.08 | scores on a scale | |
| Improvement in Clinical Global Impressions-Improvement (CGI-I) Score | Methylphenidate Transdermal System | 93 | Participants | ||
| Improvement in Clinical Global Impressions-Improvement (CGI-I) Score | Placebo (PTS) | 22 | Participants | ||
| Improvement in Parent Global Assessment (PGA) Score | Methylphenidate Transdermal System | 76 | Participants | ||
| Improvement in Parent Global Assessment (PGA) Score | Placebo (PTS) | 15 | Participants | ||
| Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint | Methylphenidate Transdermal System | 3.3 | Standard Error 1.06 | scores on a scale | |
| Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint | Placebo (PTS) | 1.3 | Standard Error 1.55 | scores on a scale |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Methylphenidate Transdermal System | 145 | |
| Overall Study | STARTED | Placebo (PTS) | 72 | |
| Overall Study | COMPLETED | Methylphenidate Transdermal System | 95 | |
| Overall Study | COMPLETED | Placebo (PTS) | 29 | |
| Overall Study | NOT COMPLETED | Methylphenidate Transdermal System | 50 | |
| Overall Study | NOT COMPLETED | Placebo (PTS) | 43 |
Source ClinicalTrials.gov
Adverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Methylphenidate Transdermal System | 14 | 145 | 14 |
| other | Nausea | Gastrointestinal disorders | Placebo (PTS) | 2 | 72 | 3 |
| other | Upper respiratory tract infection | Infections and infestations | Methylphenidate Transdermal System | 15 | 145 | 15 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo (PTS) | 7 | 72 | 7 |
| other | Weight decreased | Investigations | Methylphenidate Transdermal System | 8 | 145 | 9 |
| other | Weight decreased | Investigations | Placebo (PTS) | 1 | 72 | 1 |
| other | Decreased appetite | Metabolism and nutrition disorders | Methylphenidate Transdermal System | 37 | 145 | 41 |
| other | Decreased appetite | Metabolism and nutrition disorders | Placebo (PTS) | 1 | 72 | 1 |
| other | Dizziness | Nervous system disorders | Methylphenidate Transdermal System | 8 | 145 | 8 |
| other | Dizziness | Nervous system disorders | Placebo (PTS) | 1 | 72 | 1 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Methylphenidate Transdermal System | ||
| Total, all-cause mortality | Placebo (PTS) | ||
| Total, other adverse events | Methylphenidate Transdermal System | 125 | 145 |
| Total, other adverse events | Placebo (PTS) | 28 | 72 |
| Total, serious adverse events | Methylphenidate Transdermal System | 1 | 145 |
| Total, serious adverse events | Placebo (PTS) | 1 | 72 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20625364 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Methylphenidate Transdermal System vs Placebo (PTS): Improvement in Parent Global Assessment (PGA) Score | Trial comparisons |
| Methylphenidate Transdermal System vs Placebo (PTS): Improvement in Clinical Global Impressions-Improvement (CGI-I) Score | Trial comparisons |
| Methylphenidate Transdermal System vs Placebo (PTS): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00499863
GET https://conductscience.org/api/trials/v1/NCT00499863/results?page=2