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This is a dose-optimized, randomized, double-blind, placebo-controlled crossover study in approximately 100 pediatric patients (aged 6 to 12 years) with ADHD. Eligible patients will enroll to take open-label AR11 BID and undergo dose optimization activities for 8 weeks. Patients who achieve a stable dose during the dose optimization period will continue participation and will be randomized to take double-blind medication (AR11 or placebo) orally twice daily for 1 week. At the end of each double-blind treatment period, patients will be evaluated for ADHD symptoms in a laboratory classroom setting utilizing SKAMP and PERMP assessments.
This is a dose-optimized, randomized, double-blind, placebo-controlled crossover study in approximately 100 pediatric patients (aged 6 to 12 years) with ADHD. Eligible patients will enroll in the study to take open-label AR11 twice daily and undergo dose optimization activities for 8 weeks. Patients who achieve a stable dose during the dose optimization period will continue participation and will be randomized to take double-blind medication (AR11 or placebo) orally twice daily for 1 week. At the end of the first double-blind treatment period, patients will be evaluated for ADHD symptoms in a laboratory classroom setting utilizing SKAMP and PERMP assessments. At the end of the second double blind treatment period, patients will be evaluated for ADHD symptoms in a second laboratory classroom setting utilizing SKAMP and PERMP assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR11 (amphetamine sulfate) (1 week) - double blind | Experimental | AR11, administered orally, BID, for one week (crossover to placebo administration week 2) |
|
| Placebo (1 week) - double blind | Placebo Comparator | Placebo, administered orally, BID, for one week (crossover to AR11 administration week 2) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR11 | Drug |
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| |
| Measure | Description | Time Frame |
|---|---|---|
| SKAMP-Combined Scores | Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale [SKAMP]-combined scores measured during Laboratory Classroom Days. The SKAMP scale is a validated subjective measure of ADHD symptoms in a laboratory classroom, comprised of 13 items on which subjects are rated according to a 7 point scale (0=normal to 6=maximal impairment); maximum score 78. The SKAMP-combined score is obtained by summing the rating values for each of the 13 items, whereby the higher the SKAMP score, the greater the impairment. | 2 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| SKAMP-Combined Scores | Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale [SKAMP]-combined scores measured during Laboratory Classroom Days. The SKAMP scale is a validated subjective measure of ADHD symptoms in a laboratory classroom, comprised of 13 items on which subjects are rated according to a 7 point scale (0=normal to 6=maximal impairment); maximum score 78. The SKAMP-combined score is obtained by summing the rating values for each of the 13 items, whereby the higher the SKAMP score, the greater the impairment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurence Downey, MD | Arbor Pharmaceuticals, LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Clinical Research Center, LLC. | Bradenton | Florida | 34201 | United States | ||
| Florida Clinical Research Center, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25692608 | Background | Childress AC, Brams M, Cutler AJ, Kollins SH, Northcutt J, Padilla A, Turnbow JM. The Efficacy and Safety of Evekeo, Racemic Amphetamine Sulfate, for Treatment of Attention-Deficit/Hyperactivity Disorder Symptoms: A Multicenter, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled Crossover Laboratory Classroom Study. J Child Adolesc Psychopharmacol. 2015 Jun;25(5):402-14. doi: 10.1089/cap.2014.0176. Epub 2015 Feb 18. | |
| 30972657 |
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| ID | Title | Description |
|---|---|---|
| FG000 | AR11 (1 Week) Then Placebo (1 Week) - Double Blind | AR11, administered orally, BID, for one week (crossover to placebo administration week 2) |
| FG001 | Placebo (1 Week) Then AR11 (1 Week) - Double Blind |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo |
| Drug |
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| 0.75, 4, 6, 8, 10 hours post-dose |
| SKAMP Subscale - Attention Scores | The SKAMP scale is a validated subjective measure of ADHD symptoms. It is comprised of 13 items (grouped under the subcategories of attention, deportment, quality of work, and compliance) on which subjects are rated according to a 7-point scale (0 = normal to 6 = maximal impairment). The SKAMP-Attention subscale score is comprised of four of the 13 items with a maximum score of 24. | 0.75, 2, 4, 6, 8, and 10 hours post-dose |
| SKAMP Subscale - Deportment Scores | The SKAMP scale is a validated subjective measure of ADHD symptoms. It is comprised of 13 items (grouped under the subcategories of attention, deportment, quality of work, and compliance) on which subjects are rated according to a 7-point scale (0 = normal to 6 = maximal impairment). The SKAMP-Deportment subscale score is comprised of four of the 13 items with a maximum score of 24. | 0.75, 2, 4, 6, 8, and 10 hours post-dose |
| PERM-P Scores - Number of Problems Attempted | Permanent Product Measure of Performance (PERMP) assessments measured during Laboratory Classroom Days. The PERMP is an individualized, five-page math exam consisting of 400 problems. Subjects are instructed to complete as many math problems as possible in 10 minutes. Performance is evaluated using the number of problems attempted (maximum score = 400) and the number of problems correct (maximum score = 400). | 0.75, 2, 4, 6, 8, and 10 hours post-dose |
| PERM-P Scores - Number of Problems Correct | Permanent Product Measure of Performance (PERMP) assessments measured during Laboratory Classroom Days. The PERMP is an individualized, five-page math exam consisting of 400 problems. Subjects are instructed to complete as many math problems as possible in 10 minutes. Performance is evaluated using the number of problems attempted (maximum score = 400) and the number of problems correct (maximum score = 400). | 0.75, 2, 4, 6, 8, and 10 hours post-dose |
| Maitland |
| Florida |
| 32751 |
| United States |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| Center for Psychiatry and Behavioral Medicine, Inc. | Las Vegas | Nevada | 89128 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Bayou City Research Ltd. | Houston | Texas | 77007 | United States |
| Westex Clinical Investigations | Houston | Texas | 79423 | United States |
| Derived |
| Childress AC, Newcorn JH, Cutler AJ. Gender Effects in the Efficacy of Racemic Amphetamine Sulfate in Children with Attention-Deficit/Hyperactivity Disorder. Adv Ther. 2019 Jun;36(6):1370-1387. doi: 10.1007/s12325-019-00942-5. Epub 2019 Apr 10. |
Placebo, administered orally, BID, for one week (crossover to AR11administration week 2)
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AR11 (1 Week) Then Placebo (1 Week) - Double Blind | AR11, administered orally, BID for one week (crossover to placebo administration week 2) |
| BG001 | Placebo (1 Week) Then AR11 (1 Week) - Double Blind | Placebo, administered orally, BID for one week (crossover to AR11 administration week 2) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | SKAMP-Combined Scores | Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale [SKAMP]-combined scores measured during Laboratory Classroom Days. The SKAMP scale is a validated subjective measure of ADHD symptoms in a laboratory classroom, comprised of 13 items on which subjects are rated according to a 7 point scale (0=normal to 6=maximal impairment); maximum score 78. The SKAMP-combined score is obtained by summing the rating values for each of the 13 items, whereby the higher the SKAMP score, the greater the impairment. | ITT Population | Posted | Mean | Standard Deviation | units on a scale | 2 hours post-dose |
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| Secondary | SKAMP-Combined Scores | Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale [SKAMP]-combined scores measured during Laboratory Classroom Days. The SKAMP scale is a validated subjective measure of ADHD symptoms in a laboratory classroom, comprised of 13 items on which subjects are rated according to a 7 point scale (0=normal to 6=maximal impairment); maximum score 78. The SKAMP-combined score is obtained by summing the rating values for each of the 13 items, whereby the higher the SKAMP score, the greater the impairment. | Posted | Mean | Standard Deviation | units on a scale | 0.75, 4, 6, 8, 10 hours post-dose |
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| Secondary | SKAMP Subscale - Attention Scores | The SKAMP scale is a validated subjective measure of ADHD symptoms. It is comprised of 13 items (grouped under the subcategories of attention, deportment, quality of work, and compliance) on which subjects are rated according to a 7-point scale (0 = normal to 6 = maximal impairment). The SKAMP-Attention subscale score is comprised of four of the 13 items with a maximum score of 24. | Posted | Mean | Standard Deviation | units on a scale | 0.75, 2, 4, 6, 8, and 10 hours post-dose |
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| Secondary | SKAMP Subscale - Deportment Scores | The SKAMP scale is a validated subjective measure of ADHD symptoms. It is comprised of 13 items (grouped under the subcategories of attention, deportment, quality of work, and compliance) on which subjects are rated according to a 7-point scale (0 = normal to 6 = maximal impairment). The SKAMP-Deportment subscale score is comprised of four of the 13 items with a maximum score of 24. | Posted | Mean | Standard Deviation | units on a scale | 0.75, 2, 4, 6, 8, and 10 hours post-dose |
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| Secondary | PERM-P Scores - Number of Problems Attempted | Permanent Product Measure of Performance (PERMP) assessments measured during Laboratory Classroom Days. The PERMP is an individualized, five-page math exam consisting of 400 problems. Subjects are instructed to complete as many math problems as possible in 10 minutes. Performance is evaluated using the number of problems attempted (maximum score = 400) and the number of problems correct (maximum score = 400). | ITT | Posted | Mean | Standard Deviation | number of problems attempted | 0.75, 2, 4, 6, 8, and 10 hours post-dose |
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| Secondary | PERM-P Scores - Number of Problems Correct | Permanent Product Measure of Performance (PERMP) assessments measured during Laboratory Classroom Days. The PERMP is an individualized, five-page math exam consisting of 400 problems. Subjects are instructed to complete as many math problems as possible in 10 minutes. Performance is evaluated using the number of problems attempted (maximum score = 400) and the number of problems correct (maximum score = 400). | ITT | Posted | Mean | Standard Deviation | number of problems correct | 0.75, 2, 4, 6, 8, and 10 hours post-dose |
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AE reporting occurred during the 8-week open label treatment phase (i.e. AR11 dose optimization) and the 2-week double blind phase (i.e. crossover period)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AR11 | AR11, administered orally, BID for one week | 0 | 97 | 19 | 97 | ||
| EG001 | Placebo | Placebo, administered orally, BID for one week | 0 | 97 | 6 | 97 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| Mood swings | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| Upper abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Decreased weight | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steve Caras | Arbor Pharmaceuticals | (470) 235-2327 | scaras@arborpharma.com |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000661 | Amphetamine |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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