Attention Deficit Hyperactivity Disorder
Conditions
Keywords
Attention Deficit Hyperactivity Disorder, ADHD
Brief summary
The purpose of this study is to evaluate the association between blood drug levels and the corresponding scores of commonly used behavioral instruments based upon data collected following administration of three different methylphenidate hydrochloride extended-release drug products in children with ADHD.
Detailed description
This is a randomized, double-blind, 4-treatment and 4-period crossover study conducted in a school laboratory environment to evaluate the hour-by-hour behavioral instrument scores and hour-by-hour PK of 3 different extended-release MPH formulations as well as placebo in children with ADHD. The complete study consists of three periods: Screening, Dose Titration and Double-Blind Crossover in a Laboratory Classroom. The double-blind phase will consist of four periods (or four weeks): each week will consist of blinded administration with one of the three active methylphenidate hydrochloride treatments or placebo from Sunday through Saturday. On the last day of each period (Saturday), study participants will be evaluated in a laboratory classroom setting. On Saturdays, the blinded doses of each study drug will be administered at the school site by study staff on the morning of the test laboratory classroom day. On the other days, the medication will be taken in the morning at home.
Interventions
DRUGMethylphenidate HCl ER tablets 1
DRUGPlacebo
DRUGMethylphenidate HCl ER tablets 2
DRUGMethylphenidate HCl ER for suspension
Sponsors
Food and Drug Administration (FDA)
Center for Psychiatry And Behavioral Medicine Inc.
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female outpatients 2. Ages 6-12 years at time of screening 3. Judged by the investigator to be physically healthy and suitable for participation in the study 4. Diagnosis of DSM-5ADHD combined, predominantly inattentive or hyperactive/impulsive presentation, per clinical evaluation and confirmed by the MINI-KID 5. Clinical Global Impressions-Severity (CGI-S) ≥ 3 6. ≥ 90th percentile normative value for gender and age on the ADHD RS-IV total score at screening or baseline 7. Study participant has a parent/legal guardian who is willing and able to give written informed consent for him/her to participate in the study 8. Study participant must be able to give assent to participate in the trial 9. Study participant and legal guardian must be able to speak and understand English 10. Able to tolerate multiple finger pricks 11. Willing to comply with all study procedures
Exclusion criteria
1. Current (last month) psychiatric diagnosis other than specific phobia, motor skills disorders, oppositional defiant disorder, sleep disorders, elimination disorders, adjustment disorders, learning disorders, or communication disorders. Participants with school phobia or separation anxiety will not be eligible 2. Cognitively impaired, in the investigator's opinion 3. Any clinically significant chronic medical condition that, in the judgment of the investigator, may interfere with the participant's ability to participate in the study 4. Seizure disorder excluding a history of febrile seizures 5. Thyroid disease 6. Tourette's disorder or chronic tic disorder (mild medication induced tics are allowed) 7. Serious cardiac condition including cardiomyopathy, serious arrhythmias, structural cardiac disorders, or severe hypertension 8. Glaucoma 9. Current or recent (within the past 6 months) DSM-5 drug dependence or substance abuse (excluding nicotine and caffeine) 10. Pregnant or nursing females. Females must have a negative urine pregnancy test at screening as well as four additional visits and must be abstinent or use adequate and reliable contraception throughout the study 11. Currently treated and satisfied with ADHD medication 12. Current psychotropic medications other than sedative hypnotics for sleep 13. Use of atomoxetine, clonidine, guanfacine or a monoamine oxidase inhibitor within 28 days of the baseline visit 14. Participation in another investigational medication study within 30 days prior to screening 15. Clinically significant abnormal laboratory result, electrocardiogram (ECG) result, physical examination, or vital signs at screening that the investigator considers to be inappropriate to allow participation in the study 16. Planned use of prohibited drugs from the baseline visit through the end of the trial 17. History of allergic reaction or a known or suspected sensitivity to any substance that is contained in the study drugs 18. Food allergies that are determined by the PI as too severe to be easily accommodated for during the study 19. Inability to swallow study medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | 0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose on each classroom day | The Permanent Product Measure of Performance (PERMP) involves objective individualized mathematics tests. Scores will be obtained ten times on each classroom day at pre-dose, and at approximately 0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose. PERMP Attempted is reported here. Scale ranges 0 math questions answered to 400 math questions answered. The more number of questions answered (better score), the higher the PERMP Attempted score is. |
| Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | 0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose on each classroom day | The Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) scale is a validated, 13-item rating of subjective impairment of classroom behaviors (0 = normal/no impairment; 1 = slight impairment; 2 = mild impairment; 3 = moderate impairment; 4 = severe impairment; 5 = very severe impairment; 6 = maximal impairment). The SKAMP consists of four subscales: SKAMP-Attention, SKAMP-Deportment, SKAMP-Quality of Work, and SKAMP-Compliance, in addition to SKAMP-Total (reported here). SKAMP-Total is a sum of the four sub-scales and has a range of 0-78. The higher the score, the higher the impairment. Scores will be obtained during each classroom cycle during each full laboratory classroom day at pre-dose, and at 0.5, 1.5, 2.5, 4, 5, 6, 8, 10, and 12 hours post-dose. The scores will be based on the child's behavior during 20 minutes of each cycle. |
| Maximum Drug Concentration Observed (Cmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products | 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose on each classroom day | PK samples will be taken eight times on each classroom day at approximately 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose, and Cmax will be measured. The objectives of this measure is to estimate PK metrics, including Cmax, appropriate for characterizing rate and extent of absorption in each phase of the drug release and the evaluate the disposition and eliminating processes for each medication studied. The minimum value is pg/mL and there is was no maximum defined prior to the interventions. |
| Time to Reach Cmax (Tmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products | 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose on each classroom day | PK samples will be taken eight times on each classroom day at approximately 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose, and Tmax will be measured |
Countries
United States
Participant flow
Pre-assignment details
88 individuals signed consent. 82 individuals were eligible for the study. 80 individuals were exposed to the open-label phase (Methylphenidate HCL ER Tablets 1). 76 individuals entered the double-blind phase. 72 individuals completed the entire study. Since this is a crossover study, these were the same individuals (88 consented, not 301).
Participants by arm
| Arm | Count |
|---|---|
| Open-Label: Methylphenidate HCl ER Tablets 1 During the open-label optimization phase, one of the methylphenidate hydrochloride extended-release products will be titrated at weekly intervals of 18mg increments until an optimal dose is achieved or a maximum of 72mg per day is reached.
Methylphenidate HCl ER tablets 1 | 80 |
| Total | 80 |
Baseline characteristics
| Characteristic | Open-Label: Methylphenidate HCl ER Tablets 1 |
|---|---|
| Age, Categorical <=18 years | 80 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 9.45 years STANDARD_DEVIATION 1.86 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 45 Participants |
| Region of Enrollment United States | 80 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 74 | 0 / 73 | 0 / 74 |
| other Total, other adverse events | 69 / 80 | 12 / 74 | 20 / 73 | 23 / 74 |
| serious Total, serious adverse events | 0 / 80 | 0 / 74 | 0 / 73 | 0 / 74 |
Outcome results
Primary
Maximum Drug Concentration Observed (Cmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products
PK samples will be taken eight times on each classroom day at approximately 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose, and Cmax will be measured. The objectives of this measure is to estimate PK metrics, including Cmax, appropriate for characterizing rate and extent of absorption in each phase of the drug release and the evaluate the disposition and eliminating processes for each medication studied. The minimum value is pg/mL and there is was no maximum defined prior to the interventions.
Time frame: 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose on each classroom day
Population: 76 participants entered the double-blind randomization phase and each participant provided at least one data point for these analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methylphenidate HCl ER Tablets 1 | Maximum Drug Concentration Observed (Cmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products | 76339 pg/mL | Standard Deviation 55690 |
| Placebo | Maximum Drug Concentration Observed (Cmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products | 4327 pg/mL | Standard Deviation 4594 |
| Methylphenidate HCl ER Tablets 2 | Maximum Drug Concentration Observed (Cmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products | 81611 pg/mL | Standard Deviation 46702 |
| Methylphenidate HCl ER for Suspension | Maximum Drug Concentration Observed (Cmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products | 81498 pg/mL | Standard Deviation 66961 |
Primary
Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products
The Permanent Product Measure of Performance (PERMP) involves objective individualized mathematics tests. Scores will be obtained ten times on each classroom day at pre-dose, and at approximately 0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose. PERMP Attempted is reported here. Scale ranges 0 math questions answered to 400 math questions answered. The more number of questions answered (better score), the higher the PERMP Attempted score is.
Time frame: 0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose on each classroom day
Population: Note that not all participants who entered the study completed all arms and all time points, hence the discrepancy in number of participants analyzed between arms and different time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methylphenidate HCl ER Tablets 1 | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR .5 | 78.463 score on a scale | Standard Deviation 58.8659 |
| Methylphenidate HCl ER Tablets 1 | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 12 | 112.09 score on a scale | Standard Deviation 76.5476 |
| Methylphenidate HCl ER Tablets 1 | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 4 | 120.985 score on a scale | Standard Deviation 64.1158 |
| Methylphenidate HCl ER Tablets 1 | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 10 | 113.03 score on a scale | Standard Deviation 65.3686 |
| Methylphenidate HCl ER Tablets 1 | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 2.5 | 124.313 score on a scale | Standard Deviation 65.4757 |
| Methylphenidate HCl ER Tablets 1 | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 8 | 117.403 score on a scale | Standard Deviation 66.8252 |
| Methylphenidate HCl ER Tablets 1 | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 0 | 66.925 score on a scale | Standard Deviation 43.7199 |
| Methylphenidate HCl ER Tablets 1 | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 1.5 | 112.493 score on a scale | Standard Deviation 62.1631 |
| Methylphenidate HCl ER Tablets 1 | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 6 | 107.303 score on a scale | Standard Deviation 64.5355 |
| Methylphenidate HCl ER Tablets 1 | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 5 | 103.985 score on a scale | Standard Deviation 58.6211 |
| Placebo | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 12 | 82.718 score on a scale | Standard Deviation 50.4251 |
| Placebo | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 10 | 80.761 score on a scale | Standard Deviation 60.2045 |
| Placebo | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 0 | 95.361 score on a scale | Standard Deviation 53.7921 |
| Placebo | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR .5 | 90.194 score on a scale | Standard Deviation 67.6144 |
| Placebo | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 1.5 | 89.366 score on a scale | Standard Deviation 74.0415 |
| Placebo | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 2.5 | 86.236 score on a scale | Standard Deviation 61.5375 |
| Placebo | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 4 | 85.986 score on a scale | Standard Deviation 63.3276 |
| Placebo | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 5 | 71.718 score on a scale | Standard Deviation 56.1392 |
| Placebo | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 6 | 73.42 score on a scale | Standard Deviation 48.0843 |
| Placebo | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 8 | 82.408 score on a scale | Standard Deviation 59.657 |
| Methylphenidate HCl ER Tablets 2 | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR .5 | 88.333 score on a scale | Standard Deviation 73.9824 |
| Methylphenidate HCl ER Tablets 2 | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 12 | 109.909 score on a scale | Standard Deviation 64.7206 |
| Methylphenidate HCl ER Tablets 2 | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 4 | 130.591 score on a scale | Standard Deviation 65.7204 |
| Methylphenidate HCl ER Tablets 2 | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 5 | 117.879 score on a scale | Standard Deviation 63.5952 |
| Methylphenidate HCl ER Tablets 2 | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 0 | 80.621 score on a scale | Standard Deviation 57.0923 |
| Methylphenidate HCl ER Tablets 2 | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 10 | 103.864 score on a scale | Standard Deviation 60.7101 |
| Methylphenidate HCl ER Tablets 2 | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 6 | 112.985 score on a scale | Standard Deviation 68.729 |
| Methylphenidate HCl ER Tablets 2 | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 8 | 123.803 score on a scale | Standard Deviation 65.2423 |
| Methylphenidate HCl ER Tablets 2 | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 1.5 | 112.364 score on a scale | Standard Deviation 70.9701 |
| Methylphenidate HCl ER Tablets 2 | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 2.5 | 127.848 score on a scale | Standard Deviation 71.7946 |
| Methylphenidate HCl ER for Suspension | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 2.5 | 139.132 score on a scale | Standard Deviation 75.4724 |
| Methylphenidate HCl ER for Suspension | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 6 | 124.862 score on a scale | Standard Deviation 68.9096 |
| Methylphenidate HCl ER for Suspension | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 12 | 82.642 score on a scale | Standard Deviation 58.0224 |
| Methylphenidate HCl ER for Suspension | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 4 | 129.735 score on a scale | Standard Deviation 70.0097 |
| Methylphenidate HCl ER for Suspension | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 0 | 92.176 score on a scale | Standard Deviation 70.6378 |
| Methylphenidate HCl ER for Suspension | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 10 | 99.881 score on a scale | Standard Deviation 66.7032 |
| Methylphenidate HCl ER for Suspension | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR .5 | 114.294 score on a scale | Standard Deviation 76.9904 |
| Methylphenidate HCl ER for Suspension | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 5 | 122.91 score on a scale | Standard Deviation 72.3134 |
| Methylphenidate HCl ER for Suspension | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 8 | 97.358 score on a scale | Standard Deviation 58.9822 |
| Methylphenidate HCl ER for Suspension | Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 1.5 | 131.191 score on a scale | Standard Deviation 65.958 |
Primary
Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products
The Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) scale is a validated, 13-item rating of subjective impairment of classroom behaviors (0 = normal/no impairment; 1 = slight impairment; 2 = mild impairment; 3 = moderate impairment; 4 = severe impairment; 5 = very severe impairment; 6 = maximal impairment). The SKAMP consists of four subscales: SKAMP-Attention, SKAMP-Deportment, SKAMP-Quality of Work, and SKAMP-Compliance, in addition to SKAMP-Total (reported here). SKAMP-Total is a sum of the four sub-scales and has a range of 0-78. The higher the score, the higher the impairment. Scores will be obtained during each classroom cycle during each full laboratory classroom day at pre-dose, and at 0.5, 1.5, 2.5, 4, 5, 6, 8, 10, and 12 hours post-dose. The scores will be based on the child's behavior during 20 minutes of each cycle.
Time frame: 0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose on each classroom day
Population: Note that not all participants who entered the study completed all arms. Thus, the number differs between the arms to reflect the number of participants who provided data for that arm. N=67 for all MPH HCl ER tab 1 time points. N=72 for all placebo time points. N=66 for all MPH HCl tab 2 time points. N=68 for all MPH Hcl ER susp timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methylphenidate HCl ER Tablets 1 | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 0 | 36.4328 units on a scale | Standard Deviation 13.1209 |
| Methylphenidate HCl ER Tablets 1 | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 4 | 19.1642 units on a scale | Standard Deviation 12.216 |
| Methylphenidate HCl ER Tablets 1 | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 5 | 22.3881 units on a scale | Standard Deviation 12.7588 |
| Methylphenidate HCl ER Tablets 1 | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR .5 | 35.2836 units on a scale | Standard Deviation 15.2204 |
| Methylphenidate HCl ER Tablets 1 | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 1.5 | 23.4328 units on a scale | Standard Deviation 15.9917 |
| Methylphenidate HCl ER Tablets 1 | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 2.5 | 20.0746 units on a scale | Standard Deviation 12.6087 |
| Methylphenidate HCl ER Tablets 1 | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 6 | 22.1642 units on a scale | Standard Deviation 12.8766 |
| Methylphenidate HCl ER Tablets 1 | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 8 | 21.0448 units on a scale | Standard Deviation 11.8186 |
| Methylphenidate HCl ER Tablets 1 | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 10 | 20.7164 units on a scale | Standard Deviation 13.313 |
| Methylphenidate HCl ER Tablets 1 | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 12 | 23.0746 units on a scale | Standard Deviation 15.3981 |
| Placebo | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 1.5 | 33.9722 units on a scale | Standard Deviation 15.354 |
| Placebo | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 2.5 | 33.4861 units on a scale | Standard Deviation 13.2399 |
| Placebo | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 12 | 32.2778 units on a scale | Standard Deviation 14.396 |
| Placebo | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 6 | 35.00 units on a scale | Standard Deviation 14.7601 |
| Placebo | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 4 | 33.4028 units on a scale | Standard Deviation 13.7888 |
| Placebo | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR .5 | 30.7361 units on a scale | Standard Deviation 14.8029 |
| Placebo | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 8 | 35.0972 units on a scale | Standard Deviation 14.4038 |
| Placebo | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 0 | 27.7917 units on a scale | Standard Deviation 13.475 |
| Placebo | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 10 | 34.2222 units on a scale | Standard Deviation 14.0554 |
| Placebo | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 5 | 36.2917 units on a scale | Standard Deviation 14.1962 |
| Methylphenidate HCl ER Tablets 2 | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 6 | 15.8636 units on a scale | Standard Deviation 10.5158 |
| Methylphenidate HCl ER Tablets 2 | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR .5 | 32.1061 units on a scale | Standard Deviation 13.2875 |
| Methylphenidate HCl ER Tablets 2 | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 1.5 | 25.4091 units on a scale | Standard Deviation 13.8775 |
| Methylphenidate HCl ER Tablets 2 | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 10 | 24.4394 units on a scale | Standard Deviation 15.1679 |
| Methylphenidate HCl ER Tablets 2 | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 2.5 | 20.3939 units on a scale | Standard Deviation 13.4163 |
| Methylphenidate HCl ER Tablets 2 | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 4 | 15.7576 units on a scale | Standard Deviation 10.5233 |
| Methylphenidate HCl ER Tablets 2 | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 5 | 17.1061 units on a scale | Standard Deviation 11.9526 |
| Methylphenidate HCl ER Tablets 2 | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 0 | 34.2879 units on a scale | Standard Deviation 14.4497 |
| Methylphenidate HCl ER Tablets 2 | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 12 | 27.3485 units on a scale | Standard Deviation 15.3508 |
| Methylphenidate HCl ER Tablets 2 | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 8 | 19.3788 units on a scale | Standard Deviation 12.0509 |
| Methylphenidate HCl ER for Suspension | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 2.5 | 15.8088 units on a scale | Standard Deviation 10.9466 |
| Methylphenidate HCl ER for Suspension | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR .5 | 27.0588 units on a scale | Standard Deviation 16.1466 |
| Methylphenidate HCl ER for Suspension | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 6 | 22.8382 units on a scale | Standard Deviation 14.8078 |
| Methylphenidate HCl ER for Suspension | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 0 | 33.4706 units on a scale | Standard Deviation 14.7855 |
| Methylphenidate HCl ER for Suspension | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 12 | 34.7353 units on a scale | Standard Deviation 15.3123 |
| Methylphenidate HCl ER for Suspension | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 1.5 | 17.8676 units on a scale | Standard Deviation 12.9233 |
| Methylphenidate HCl ER for Suspension | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 10 | 31.9412 units on a scale | Standard Deviation 13.7329 |
| Methylphenidate HCl ER for Suspension | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 4 | 17.4412 units on a scale | Standard Deviation 12.3462 |
| Methylphenidate HCl ER for Suspension | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 8 | 28.3382 units on a scale | Standard Deviation 14.6548 |
| Methylphenidate HCl ER for Suspension | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products | HOUR 5 | 20.6765 units on a scale | Standard Deviation 13.3108 |
Primary
Time to Reach Cmax (Tmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products
PK samples will be taken eight times on each classroom day at approximately 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose, and Tmax will be measured
Time frame: 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose on each classroom day
Population: 76 participants entered the double-blind randomization phase and each participant provided at least one data point for these analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methylphenidate HCl ER Tablets 1 | Time to Reach Cmax (Tmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products | 7.35 Hours | Standard Deviation 3.05 |
| Placebo | Time to Reach Cmax (Tmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products | 4.7 Hours | Standard Deviation 2.99 |
| Methylphenidate HCl ER Tablets 2 | Time to Reach Cmax (Tmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products | 6.35 Hours | Standard Deviation 2.22 |
| Methylphenidate HCl ER for Suspension | Time to Reach Cmax (Tmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products | 3.97 Hours | Standard Deviation 2.19 |