Trial · NCT01711021
Study to Evaluate Safety & Efficacy of d-Amphetamine Transdermal System vs Placebo in Children & Adolescents With ADHD
NCT01711021, Phase 2, Completed, Noven Pharmaceuticals, Inc.; results first posted 2023-12-21
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study to Evaluate Safety & Efficacy of d-Amphetamine Transdermal System vs Placebo in Children & Adolescents With ADHD. Trials, record NCT01711021. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01711021
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Safety & Efficacy of d-Amphetamine Transdermal System vs Placebo in Children & Adolescents With ADHD
- NCT number
- NCT01711021
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 110 participants, actual
- Lead sponsor
- Noven Pharmaceuticals, Inc.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- d-Amphetamine Transdermal Patch, Placebo patch
- First posted
- 2012-10-22
- Last updated
- 2023-12-21
- Results first posted
- 2023-12-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Total Score During the Double-Blind Treatment Period | Mean SKAMP Total Score of SKAMP Total Scores from 9 different time points including (1, 2, 3, 4.5, 6, 7, 9, 10, 12 hours post-dose) | The SKAMP total score comprises all 13 items. The SKAMP was designed for independent observers to rate 13 items representing 2 factors of classroom behavior: attention (SKAMP-A) and deportment (SKAMP-D), as well as quality of work. Items are specific to place (classroom setting) \& time (during a typical classroom period), \& the scale is used to assess multiple ratings taken within a day. The SKAMP-D subscale evaluates deportment, including interacting with other children, interacting with adults, remaining quiet according to classroom rules, \& staying seated according to classroom rules. The SKAMP-A subscale is a measure of attention \& evaluates getting started on assignments, sticking with tasks, attending to an activity, and making activity transitions. The SKAMP quality of work subscale includes 3 items: completing assigned work, performing work accurately, and being careful and neat while writing or drawing. Scores range from 0-78 with higher scores indicating worse impairment. |
| Secondary | Onset of Efficacy Measured by Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Total Score | Onset of efficacy defined as the time of the first assessment time showing statistical significance between d-ATS and placebo. 2 hours post-dose in Double-Blind Treatment Period | Onset of efficacy defined as the time of the first assessment time showing statistical significance between d-ATS and placebo. The time point for the reported data are SKAMP scores (LS mean) from 2 hours post-dose. The SKAMP total score comprises all 13 items. The SKAMP was designed for independent observers to rate 13 items representing 2 factors of classroom behavior: attention (SKAMP-A) and deportment (SKAMP-D), as well as quality of work. Items are specific to place (classroom setting) \& time (during a typical classroom period), \& the scale is used to assess multiple ratings taken within a day. Scores range from 0-78 with higher scores indicating worse impairment. |
| Secondary | Duration of Effect for d-Amphetamine and Placebo Treatment | Duration of Effect was from onset (2 hours post-dose) and up to 12 hours post-dose (p<0.001) | Duration of Effect is the difference between the End of Effect and Onset of Effect in hours, where End of Effect is the first time point after Onset of Effect at which the 50% reduction in SKAMP total score from pre-dose is not observed. |
| Secondary | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | 1,2, 3, 4.5,6,7,9,10 and 12 hours post-dose from double-blind treatment period | To assess efficacy of d-ATS compared to placebo as measured by the PERMP-C (number of correct answers) and PERMP-A (number of attempted answers) score. The PERMP is an age-adjusted written math test, of 10 minutes' duration administered at multiple time points. Subjects are given 5 pages of 80 math problems (400 total problems) and are instructed to work at their desks and to complete as many problems as possible in 10 minutes. Performance is measured as the number of problems attempted (PERMP-A) and the number of problems worked correctly (PERMP-C). The scores range from 0-800 with higher scores indicating better performance. |
| Secondary | Change in the Clinician-rated Scale of ADHD Symptoms Based on DSM-IV-TR Criteria (ADHD-RS-IV). | Averaged from week 6 and week 7 results during the Double-Blind Cross-Over treatment period. | The ADHD-RS-IV is based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria to assess efficacy of d-ATS compared to placebo. The ADHD-RS-IV scale was developed to measure the behaviors of children with ADHD, and it consists of 18 items designed to reflect current symptomatology of ADHD based on DSM-IV criteria. Each item is scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0 to 54. Note: Week 6 is the first week of the double-blind treatment period, week 7 is the second week of the double-blind treatment period. |
| Secondary | Conners Parent Rating Scale Revised Short Form (CPRS-R:S) Total Scores From Week 6 and Week 7 | Combined analysis by treatment groups from week 6 and week 7 (averaged) | The CPRS-R:S evaluates problem behaviors as reported by the parent or alternative caregivers. The CPRS-R:S total score comprises 27 items and covers a subset of the subscales and items on the long parent form. The score ranges from 0-81 calculated from summed subscales scores. Higher score is considered a worse outcome for ADHD patients. Note: Week 6 is the first week of the double-blind treatment period, week 7 is the second week of the double-blind treatment period. |
| Secondary | Number of Responders Evaluated by Clinical Global Impression (CGI-I) Scale by Treatments From the Double-blind Treatment Period | the double-blind treatment period | The CGI scale permits a global evaluation of the subject's improvement over time. During the Dose Optimization Period and the Double-Blind Treatment Period, the investigator assessed the subject's improvement relative to symptoms prior to dosing, using the CGI-I Scale. For CGI-I scale, the responders are defined as subjects achieving a score of 1. Very much improved or 2. Much improved or The non-responders are defined as subjects achieving a score of 3. Minimally improved on the clinician-rated CGI global improvement item or 4. No change or 5. Minimally worse or 6. Much worse or 7. Very much worse Then the number of responders are calculated by treatment arms. Note: Week 6 is the first week of the double-blind treatment period, week 7 is the second week of the double-blind treatment period. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Total Score During the Double-Blind Treatment Period | Mean SKAMP Total Score of SKAMP Total Scores from 9 different time points including (1, 2, 3, 4.5, 6, 7, 9, 10, 12 hours post-dose) | Full Analysis Set: included all consented and randomized subjects who took at least 1 dose of study of medication | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Onset of Efficacy Measured by Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Total Score | Onset of efficacy defined as the time of the first assessment time showing statistical significance between d-ATS and placebo. 2 hours post-dose in Double-Blind Treatment Period | Full Analysis Set: included all consented and randomized subjects who took at least 1 dose of study of medication. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Duration of Effect for d-Amphetamine and Placebo Treatment | Duration of Effect was from onset (2 hours post-dose) and up to 12 hours post-dose (p<0.001) | Full Analysis Set: included all consented and randomized subjects who took at least 1 dose of study of medication. | Hours | LEAST_SQUARES_MEAN |
| SECONDARY | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | 1,2, 3, 4.5,6,7,9,10 and 12 hours post-dose from double-blind treatment period | Full Analysis Set: included all consented and randomized subjects who took at least 1 dose of study of medication | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in the Clinician-rated Scale of ADHD Symptoms Based on DSM-IV-TR Criteria (ADHD-RS-IV). | Averaged from week 6 and week 7 results during the Double-Blind Cross-Over treatment period. | Full Analysis Set | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Conners Parent Rating Scale Revised Short Form (CPRS-R:S) Total Scores From Week 6 and Week 7 | Combined analysis by treatment groups from week 6 and week 7 (averaged) | Full Analysis Set Double-Blind period Week 6 and Week 7 | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Responders Evaluated by Clinical Global Impression (CGI-I) Scale by Treatments From the Double-blind Treatment Period | the double-blind treatment period | Responder includes the categories Very Much Improved and Much Improved; Non-Responder includes all other categories, with the exception of not assessed which has been considered missing data.~Note: the Full Analysis Set is 106 (N) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Total Score During the Double-Blind Treatment Period | d-Amphetamine Transdermal Patch | 12.81 | Standard Error .32 | score on a scale | |
| Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Total Score During the Double-Blind Treatment Period | Placebo Patch | 18.67 | Standard Error .322 | score on a scale | |
| Onset of Efficacy Measured by Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Total Score | d-Amphetamine Transdermal Patch | 12.2 | Standard Error 1.01 | score on a scale | |
| Onset of Efficacy Measured by Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Total Score | Placebo Patch | 19.0 | Standard Error 1.02 | score on a scale | |
| Duration of Effect for d-Amphetamine and Placebo Treatment | d-Amphetamine Transdermal Patch | 2.6 | Standard Error 2.08 | Hours | |
| Duration of Effect for d-Amphetamine and Placebo Treatment | Placebo Patch | 1.7 | Standard Error 0.96 | Hours | |
| Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | d-Amphetamine Transdermal Patch | PERMP-C at 1 hour | 124.0 | Standard Error 6.04 | score on a scale |
| Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | Placebo Patch | PERMP-C at 1 hour | 113.1 | Standard Error 6.07 | score on a scale |
| Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | d-Amphetamine Transdermal Patch | PERMP-C at 2 hours | 139.8 | Standard Error 6.02 | score on a scale |
| Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | Placebo Patch | PERMP-C at 2 hours | 103.8 | Standard Error 6.07 | score on a scale |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-Label Dose Optimization Period | STARTED | d-Amphetamine Transdermal Patch | 110 | |
| Open-Label Dose Optimization Period | STARTED | Placebo Patch | 0 | |
| Open-Label Dose Optimization Period | COMPLETED | d-Amphetamine Transdermal Patch | 106 | |
| Open-Label Dose Optimization Period | COMPLETED | Placebo Patch | 0 | |
| Open-Label Dose Optimization Period | NOT COMPLETED | d-Amphetamine Transdermal Patch | 4 | |
| Open-Label Dose Optimization Period | NOT COMPLETED | Placebo Patch | 0 | |
| Double-blind Cross-Over Treatment Period | STARTED | d-Amphetamine Transdermal Patch | 53 | |
| Double-blind Cross-Over Treatment Period | STARTED | Placebo Patch | 53 | |
| Double-blind Cross-Over Treatment Period | COMPLETED | d-Amphetamine Transdermal Patch | 46 | |
| Double-blind Cross-Over Treatment Period | COMPLETED | Placebo Patch | 46 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events60
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 | Decreased appetite | Metabolism and nutrition disorders | All d-ATS Treatment During the Dose-Optimization Phase | 64 | 110 | |
| other | Decreased appetite | Metabolism and nutrition disorders | d-ATS Patch Treated Arm During the Double Blind Phase | 13 | 106 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Placebo Treated Arm During the Double Blind Phase | 2 | 106 | |
| other | Hyperkalemia | Metabolism and nutrition disorders | All d-ATS Treatment During the Dose-Optimization Phase | 9 | 110 | |
| other | Hyperkalemia | Metabolism and nutrition disorders | d-ATS Patch Treated Arm During the Double Blind Phase | 4 | 106 | |
| other | Hyperkalemia | Metabolism and nutrition disorders | Placebo Treated Arm During the Double Blind Phase | 5 | 106 | |
| other | Insomnia | Psychiatric disorders | All d-ATS Treatment During the Dose-Optimization Phase | 29 | 110 | |
| other | Insomnia | Psychiatric disorders | d-ATS Patch Treated Arm During the Double Blind Phase | 6 | 106 | |
| other | Insomnia | Psychiatric disorders | Placebo Treated Arm During the Double Blind Phase | 5 | 106 | |
| other | Affect lability | Psychiatric disorders | All d-ATS Treatment During the Dose-Optimization Phase | 14 | 110 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All d-ATS Treatment During the Dose-Optimization Phase | 0 | 110 |
| Total, all-cause mortality | d-ATS Patch Treated Arm During the Double Blind Phase | 0 | 106 |
| Total, all-cause mortality | Placebo Treated Arm During the Double Blind Phase | 0 | 106 |
| Total, other adverse events | All d-ATS Treatment During the Dose-Optimization Phase | 108 | 110 |
| Total, other adverse events | d-ATS Patch Treated Arm During the Double Blind Phase | 44 | 106 |
| Total, other adverse events | Placebo Treated Arm During the Double Blind Phase | 32 | 106 |
| Total, serious adverse events | All d-ATS Treatment During the Dose-Optimization Phase | 0 | 110 |
| Total, serious adverse events | d-ATS Patch Treated Arm During the Double Blind Phase | 0 | 106 |
| Total, serious adverse events | Placebo Treated Arm During the Double Blind Phase | 0 | 106 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| d-Amphetamine Transdermal Patch vs Placebo Patch: Number of Responders Evaluated by Clinical Global Impression (CGI-I) Scale by Treatments From the Double-blind Treatment Period |
Source 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/NCT01711021
GET https://conductscience.org/api/trials/v1/NCT01711021/results?page=2