Attention Deficit Hyperactivity Disorder
Conditions
Keywords
ADHD
Brief summary
This study will evaluate safety and efficacy of d-Amphetamine Transdermal System for the treatment of Attention Deficit Hyperactivity Disorder in children and adolescents.
Detailed description
The study will consist of a four-week screening period, a 3-day wash-out period (if applicable), a five-week open-label, step-wise dose optimization period and two-week double blind randomized crossover treatment period with weekly classroom assessments and a safety follow-up by telephone 7 - 10 days after last dose of study drug.
Interventions
DRUGd-Amphetamine Transdermal Patch
The study was conducted in 2 parts: a 5 week, open-label, step-wise Dose Optimization Period and a 2-week, randomized, cross-over Double-Blind Treatment Period. Patches will be worn for 9 hours every day. After 9 hours the patch will be removed. Every day a new patch will be applied.
DRUGPlacebo patch
The study was conducted in 2 parts: a 5 week, open-label, step-wise Dose Optimization Period and a 2-week, randomized, cross-over Double-Blind Treatment Period. Patches will be worn for 9 hours every day. After 9 hours the patch will be removed. Every day a new patch will be applied.
Sponsors
Noven Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Gender: Male or female 2. Age: Between 6 and 17 years of age (inclusive) 3. Race: All eligible 4. Females of child-bearing potential must have agreed to practice a clinically accepted method of contraception during the study and for at least 1 month prior to study dosing and 1 month following completion of the study. Acceptable contraceptive methods included abstinence, oral contraception, surgical sterilization (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), intrauterine device, diaphragm in addition to spermicidal foam and condom on male partner, or systemic contraception (e.g., Norplant System) 5. Must have met Diagnostic and Statistical Manual of Mental Disorders, 4th edition - Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD combined, hyperactive/impulsive subtype, or predominately inattentive subtype 6. The Screening and Baseline visit ADHD-RS-IV total score must have been ≥90% of the general population of children by age and gender 7. Able to wear a patch for 9 hours (for children and, if applicable, for adolescents, parent or caregiver must be present to apply and remove the patches and maintain the used and unused patches in a secure, controlled area of the home) 8. Functioning at an age-appropriate level intellectually as determined by an intelligence quotient (IQ) of ≥80 on the Wechsler Abbreviated Scale of Intelligence II™ (WASI II™) vocabulary and matrix reasoning components 9. Must have been able to complete PERMP assessment 10. Must have provided parental consent (signed ICF) and obtained written/verbal assent from the subject 11. Subject and parent(s)/ caregiver must have been willing and able to comply with all the protocol requirements and parent(s) or caregiver must be able to provide transportation for the subject to and from the analog classroom sessions
Exclusion criteria
1. Blood pressure outside the 95th percentile for age and gender 2. Pulse of \<50 (age 6 - 17), or \>120 (age 6 - 12), or \>125 (age 13 - 17) 3. Known non-responder to amphetamine treatment 4. Documented allergy, intolerance, or hypersensitivity to amphetamine 5. Currently taking an ADHD medication that is providing symptom control with no residual impairment at home or school and has acceptable tolerability and adherence 6. Recent history (within the past 6 months) of suspected substance abuse or dependence disorder (including nicotine) 7. History of seizures during the last 2 years (excluding infantile febrile seizures), a tic disorder (exclusive of transient tic disorder), a current diagnosis, and/or a family history of Tourette's Disorder. Mild medication-induced tics were not exclusionary 8. Any psychiatric disorder that could interfere with study participation or the safety of the subject or other participants, such as conduct disorder (CD) or oppositional defiant disorder (ODD) with a history of prominent aggressive outbursts. Children meeting CD or ODD but without prominent aggression will be allowed to enroll at the discretion of the Investigator 9. Autism or Asperger's Disorder 10. Family history (first degree relatives) of sudden cardiac death 11. Current controlled (requiring medication) or uncontrolled comorbid psychiatric conditions such as post-traumatic stress disorder, psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder, was considered a suicide risk, had recent (last 6 months) suicidal ideation, or any lifetime self-harm event 12. History of abnormal thyroid function 13. Has a body mass index (BMI) for age greater than 95th percentile per Centers for Disease Control BMI (for gender-specific charts) 14. Known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug 15. Any skin abnormality present at the potential application site (i.e., infection, rash, atrophy, excessive fragility or dryness, any cut or abrasion, or tattoo) 16. History of hypersensitivity, allergy to topical medication, preparation, or adhesive dressings 17. Concurrent chronic or significant acute illnesses (such as severe allergic rhinitis or an infectious process requiring antibiotics, unless expected to resolve or has resolved by Day 0) disability or any unstable medical condition that in the Investigator's opinion would lead to difficulty complying with the protocol requirements 18. Used any investigational drug within 30 days of the Screening visit 19. History of physical, sexual, or emotional abuse in the last year 20. Medical history of hepatitis A/B/C or HIV 21. Positive urine drug screen for drugs of abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Pre-assignment details
The study consisted of 2 study periods. Period 1 is a 5-week open-label Dose Optimization Study with only one arm, Period 2 is a randomized, cross-over, double-blind treatment study (2 weeks). A total of 110 subjects were enrolled into the Dose Optimization Treatment (Period 1). 4 subjects did not complete the Dose Optimization Period. 106 subjects were randomized into the Double-Blind Treatment Period (Period 2).
Participants by arm
| Arm | Count |
|---|---|
| Baseline Characteristics for All Subjects Enrolled Baseline Characteristics are presented for all subjects that were enrolled (n=110). | 110 |
| Total | 110 |
Baseline characteristics
| Characteristic | Baseline Characteristics for All Subjects Enrolled |
|---|---|
| Age, Categorical <=18 years | 110 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 10.5 years STANDARD_DEVIATION 3.09 |
| Age, Customized Median Age | 10 years |
| BMI | 18.68 kg/m^2 STANDARD_DEVIATION 3.369 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 40 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 84 Participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 110 | 0 / 106 | 0 / 106 |
| other Total, other adverse events | 108 / 110 | 44 / 106 | 32 / 106 |
| serious Total, serious adverse events | 0 / 110 | 0 / 106 | 0 / 106 |
Outcome results
Primary
Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Total Score During the Double-Blind Treatment Period
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.
Time frame: 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)
Population: Full Analysis Set: included all consented and randomized subjects who took at least 1 dose of study of medication
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| d-Amphetamine Transdermal Patch | Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Total Score During the Double-Blind Treatment Period | 12.81 score on a scale | Standard Error 0.32 |
| Placebo Patch | Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Total Score During the Double-Blind Treatment Period | 18.67 score on a scale | Standard Error 0.322 |
p-value: <0.00195% CI: [-6.76, -4.97]Mixed Models Analysis
Secondary
Change in the Clinician-rated Scale of ADHD Symptoms Based on DSM-IV-TR Criteria (ADHD-RS-IV).
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.
Time frame: Averaged from week 6 and week 7 results during the Double-Blind Cross-Over treatment period.
Population: Full Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| d-Amphetamine Transdermal Patch | Change in the Clinician-rated Scale of ADHD Symptoms Based on DSM-IV-TR Criteria (ADHD-RS-IV). | -23.4 score on a scale | Standard Deviation 1.02 |
| Placebo Patch | Change in the Clinician-rated Scale of ADHD Symptoms Based on DSM-IV-TR Criteria (ADHD-RS-IV). | -10.3 score on a scale | Standard Deviation 1.02 |
Secondary
Conners Parent Rating Scale Revised Short Form (CPRS-R:S) Total Scores From Week 6 and Week 7
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.
Time frame: Combined analysis by treatment groups from week 6 and week 7 (averaged)
Population: Full Analysis Set Double-Blind period Week 6 and Week 7
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| d-Amphetamine Transdermal Patch | Conners Parent Rating Scale Revised Short Form (CPRS-R:S) Total Scores From Week 6 and Week 7 | 23.5 score on a scale | Standard Error 1.75 |
| Placebo Patch | Conners Parent Rating Scale Revised Short Form (CPRS-R:S) Total Scores From Week 6 and Week 7 | 39.5 score on a scale | Standard Error 1.75 |
Secondary
Duration of Effect for d-Amphetamine and Placebo Treatment
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.
Time frame: Duration of Effect was from onset (2 hours post-dose) and up to 12 hours post-dose (p<0.001)
Population: Full Analysis Set: included all consented and randomized subjects who took at least 1 dose of study of medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| d-Amphetamine Transdermal Patch | Duration of Effect for d-Amphetamine and Placebo Treatment | 2.6 Hours | Standard Error 2.08 |
| Placebo Patch | Duration of Effect for d-Amphetamine and Placebo Treatment | 1.7 Hours | Standard Error 0.96 |
p-value: 0.01Mixed Models Analysis
Secondary
Number of Responders Evaluated by Clinical Global Impression (CGI-I) Scale by Treatments From 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.
Time frame: the double-blind treatment period
Population: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| d-Amphetamine Transdermal Patch | Number of Responders Evaluated by Clinical Global Impression (CGI-I) Scale by Treatments From the Double-blind Treatment Period | 89 Participants |
| Placebo Patch | Number of Responders Evaluated by Clinical Global Impression (CGI-I) Scale by Treatments From the Double-blind Treatment Period | 25 Participants |
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. 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.
Time frame: 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
Population: Full Analysis Set: included all consented and randomized subjects who took at least 1 dose of study of medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| d-Amphetamine Transdermal Patch | Onset of Efficacy Measured by Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Total Score | 12.2 score on a scale | Standard Error 1.01 |
| Placebo Patch | Onset of Efficacy Measured by Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Total Score | 19.0 score on a scale | Standard Error 1.02 |
Secondary
Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose
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.
Time frame: 1,2, 3, 4.5,6,7,9,10 and 12 hours post-dose from double-blind treatment period
Population: Full Analysis Set: included all consented and randomized subjects who took at least 1 dose of study of medication
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| d-Amphetamine Transdermal Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-C at 1 hour | 124.0 score on a scale | Standard Error 6.04 |
| d-Amphetamine Transdermal Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-C at 2 hours | 139.8 score on a scale | Standard Error 6.02 |
| d-Amphetamine Transdermal Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-C at 3 hours | 141.2 score on a scale | Standard Error 6.02 |
| d-Amphetamine Transdermal Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-C at 4.5 hours | 141.5 score on a scale | Standard Error 6.02 |
| d-Amphetamine Transdermal Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-C at 6 hours | 139.7 score on a scale | Standard Error 6.02 |
| d-Amphetamine Transdermal Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-C at 7 hours | 139.7 score on a scale | Standard Error 6.02 |
| d-Amphetamine Transdermal Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-C at 9 hours | 139.0 score on a scale | Standard Error 6.07 |
| d-Amphetamine Transdermal Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-C at 10 hours | 132.4 score on a scale | Standard Error 6.07 |
| d-Amphetamine Transdermal Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-C at 12 hours | 135.3 score on a scale | Standard Error 6.07 |
| d-Amphetamine Transdermal Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-A at 1 hour | 126.6 score on a scale | Standard Error 6.07 |
| d-Amphetamine Transdermal Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-A at 2 hours | 142.7 score on a scale | Standard Error 6.04 |
| d-Amphetamine Transdermal Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-A at 3 hours | 144.0 score on a scale | Standard Error 6.04 |
| d-Amphetamine Transdermal Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-A at 4.5 hours | 144.0 score on a scale | Standard Error 6.04 |
| d-Amphetamine Transdermal Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-A at 6 hours | 142.0 score on a scale | Standard Error 6.04 |
| d-Amphetamine Transdermal Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-A at 7 hours | 142.3 score on a scale | Standard Error 6.04 |
| d-Amphetamine Transdermal Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-A at 9 hours | 141.7 score on a scale | Standard Error 6.1 |
| d-Amphetamine Transdermal Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-A at 10 hours | 134.7 score on a scale | Standard Error 6.1 |
| d-Amphetamine Transdermal Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-A at 12 hours | 137.4 score on a scale | Standard Error 6.1 |
| Placebo Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-A at 6 hours | 96.8 score on a scale | Standard Error 6.1 |
| Placebo Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-C at 1 hour | 113.1 score on a scale | Standard Error 6.07 |
| Placebo Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-A at 1 hour | 116.3 score on a scale | Standard Error 6.1 |
| Placebo Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-C at 2 hours | 103.8 score on a scale | Standard Error 6.07 |
| Placebo Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-A at 12 hours | 100.1 score on a scale | Standard Error 6.1 |
| Placebo Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-C at 3 hours | 93.7 score on a scale | Standard Error 6.07 |
| Placebo Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-A at 2 hours | 106.3 score on a scale | Standard Error 6.1 |
| Placebo Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-C at 4.5 hours | 97.9 score on a scale | Standard Error 6.07 |
| Placebo Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-A at 7 hours | 98.9 score on a scale | Standard Error 6.13 |
| Placebo Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-C at 6 hours | 94.3 score on a scale | Standard Error 6.07 |
| Placebo Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-A at 3 hours | 97.4 score on a scale | Standard Error 6.1 |
| Placebo Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-C at 7 hours | 96.2 score on a scale | Standard Error 6.1 |
| Placebo Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-A at 10 hours | 102.1 score on a scale | Standard Error 6.1 |
| Placebo Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-C at 9 hours | 102.9 score on a scale | Standard Error 6.07 |
| Placebo Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-A at 4.5 hours | 100.9 score on a scale | Standard Error 6.1 |
| Placebo Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-C at 10 hours | 98.9 score on a scale | Standard Error 6.07 |
| Placebo Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-A at 9 hours | 106.8 score on a scale | Standard Error 6.1 |
| Placebo Patch | Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose | PERMP-C at 12 hours | 96.4 score on a scale | Standard Error 6.07 |