Trial Outcomes & Findings for Crossover Study to Evaluate the Efficacy of AR11 in Pediatric Patients With ADHD in a Laboratory Classroom Setting (NCT NCT01986062)
NCT ID: NCT01986062
Last Updated: 2020-07-21
Results Overview
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.
COMPLETED
PHASE4
97 participants
2 hours post-dose
2020-07-21
Participant Flow
Participant milestones
| Measure |
AR11 (1 Week) Then Placebo (1 Week) - Double Blind
AR11, administered orally, BID, for one week (crossover to placebo administration week 2)
|
Placebo (1 Week) Then AR11 (1 Week) - Double Blind
Placebo, administered orally, BID, for one week (crossover to AR11administration week 2)
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
50
|
|
Overall Study
COMPLETED
|
46
|
49
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
AR11 (1 Week) Then Placebo (1 Week) - Double Blind
AR11, administered orally, BID, for one week (crossover to placebo administration week 2)
|
Placebo (1 Week) Then AR11 (1 Week) - Double Blind
Placebo, administered orally, BID, for one week (crossover to AR11administration week 2)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Crossover Study to Evaluate the Efficacy of AR11 in Pediatric Patients With ADHD in a Laboratory Classroom Setting
Baseline characteristics by cohort
| Measure |
AR11 (1 Week) Then Placebo (1 Week) - Double Blind
n=47 Participants
AR11, administered orally, BID for one week (crossover to placebo administration week 2)
|
Placebo (1 Week) Then AR11 (1 Week) - Double Blind
n=50 Participants
Placebo, administered orally, BID for one week (crossover to AR11 administration week 2)
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.6 years
STANDARD_DEVIATION 1.97 • n=93 Participants
|
9.6 years
STANDARD_DEVIATION 1.78 • n=4 Participants
|
9.6 years
STANDARD_DEVIATION 1.86 • n=27 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
59 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=93 Participants
|
50 participants
n=4 Participants
|
97 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 2 hours post-dosePopulation: ITT Population
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.
Outcome measures
| Measure |
AR11 (Amphetamine Sulfate)
n=95 Participants
AR11, administered orally, BID, 10-40 mg/day
|
Placebo
n=97 Participants
Placebo, administered orally, BID
|
|---|---|---|
|
SKAMP-Combined Scores
|
10.0 units on a scale
Standard Deviation 8.24
|
17.8 units on a scale
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: 0.75, 4, 6, 8, 10 hours post-doseSwanson, 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.
Outcome measures
| Measure |
AR11 (Amphetamine Sulfate)
n=95 Participants
AR11, administered orally, BID, 10-40 mg/day
|
Placebo
n=97 Participants
Placebo, administered orally, BID
|
|---|---|---|
|
SKAMP-Combined Scores
0.75 hours post-dose
|
11.8 units on a scale
Standard Deviation 10.56
|
17.3 units on a scale
Standard Deviation 11.38
|
|
SKAMP-Combined Scores
4 hours post-dose
|
11.6 units on a scale
Standard Deviation 10.04
|
19.8 units on a scale
Standard Deviation 11.92
|
|
SKAMP-Combined Scores
6 hours post-dose
|
14.5 units on a scale
Standard Deviation 10.38
|
20.2 units on a scale
Standard Deviation 11.28
|
|
SKAMP-Combined Scores
8 hours post-dose
|
16.0 units on a scale
Standard Deviation 11.76
|
22.0 units on a scale
Standard Deviation 12.33
|
|
SKAMP-Combined Scores
10 hours post-dose
|
16.5 units on a scale
Standard Deviation 11.08
|
20.8 units on a scale
Standard Deviation 13.33
|
SECONDARY outcome
Timeframe: 0.75, 2, 4, 6, 8, and 10 hours post-doseThe 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.
Outcome measures
| Measure |
AR11 (Amphetamine Sulfate)
n=95 Participants
AR11, administered orally, BID, 10-40 mg/day
|
Placebo
n=97 Participants
Placebo, administered orally, BID
|
|---|---|---|
|
SKAMP Subscale - Attention Scores
0.75 hours post-dose
|
2.2 units on a scale
Standard Deviation 2.64
|
3.4 units on a scale
Standard Deviation 3.06
|
|
SKAMP Subscale - Attention Scores
2.0 hours post-dose
|
1.9 units on a scale
Standard Deviation 2.26
|
3.4 units on a scale
Standard Deviation 3.1
|
|
SKAMP Subscale - Attention Scores
4.0 hours post-dose
|
2.2 units on a scale
Standard Deviation 2.68
|
4.0 units on a scale
Standard Deviation 3.04
|
|
SKAMP Subscale - Attention Scores
6.0 hours post-dose
|
2.3 units on a scale
Standard Deviation 2.43
|
3.6 units on a scale
Standard Deviation 2.95
|
|
SKAMP Subscale - Attention Scores
8.0 hours post-dose
|
2.8 units on a scale
Standard Deviation 2.8
|
4.1 units on a scale
Standard Deviation 3.01
|
|
SKAMP Subscale - Attention Scores
10.0 hours post-dose
|
3.2 units on a scale
Standard Deviation 3.15
|
4.0 units on a scale
Standard Deviation 3.59
|
SECONDARY outcome
Timeframe: 0.75, 2, 4, 6, 8, and 10 hours post-doseThe 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.
Outcome measures
| Measure |
AR11 (Amphetamine Sulfate)
n=95 Participants
AR11, administered orally, BID, 10-40 mg/day
|
Placebo
n=97 Participants
Placebo, administered orally, BID
|
|---|---|---|
|
SKAMP Subscale - Deportment Scores
10.0 hours post-dose
|
3.1 units on a scale
Standard Deviation 3.72
|
4.9 units on a scale
Standard Deviation 5.21
|
|
SKAMP Subscale - Deportment Scores
0.75 hours post-dose
|
2.1 units on a scale
Standard Deviation 3.53
|
3.9 units on a scale
Standard Deviation 4.82
|
|
SKAMP Subscale - Deportment Scores
2.0 hours post-dose
|
1.6 units on a scale
Standard Deviation 2.79
|
4.0 units on a scale
Standard Deviation 4.58
|
|
SKAMP Subscale - Deportment Scores
4.0 hours post-dose
|
2.1 units on a scale
Standard Deviation 3.47
|
4.7 units on a scale
Standard Deviation 4.86
|
|
SKAMP Subscale - Deportment Scores
6.0 hours post-dose
|
3.1 units on a scale
Standard Deviation 4.21
|
4.3 units on a scale
Standard Deviation 4.51
|
|
SKAMP Subscale - Deportment Scores
8.0 hours post-dose
|
3.5 units on a scale
Standard Deviation 4.38
|
4.9 units on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: 0.75, 2, 4, 6, 8, and 10 hours post-dosePopulation: ITT
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).
Outcome measures
| Measure |
AR11 (Amphetamine Sulfate)
n=95 Participants
AR11, administered orally, BID, 10-40 mg/day
|
Placebo
n=97 Participants
Placebo, administered orally, BID
|
|---|---|---|
|
PERM-P Scores - Number of Problems Attempted
0.75 hours post-dose
|
111.6 number of problems attempted
Standard Deviation 53.53
|
91.2 number of problems attempted
Standard Deviation 47.35
|
|
PERM-P Scores - Number of Problems Attempted
2.0 hours post-dose
|
113.4 number of problems attempted
Standard Deviation 51.27
|
85.7 number of problems attempted
Standard Deviation 46.66
|
|
PERM-P Scores - Number of Problems Attempted
4.0 hours post-dose
|
113.2 number of problems attempted
Standard Deviation 56.28
|
85.1 number of problems attempted
Standard Deviation 45.89
|
|
PERM-P Scores - Number of Problems Attempted
6.0 hours post-dose
|
101.3 number of problems attempted
Standard Deviation 54.26
|
74.9 number of problems attempted
Standard Deviation 43.08
|
|
PERM-P Scores - Number of Problems Attempted
8.0 hours post-dose
|
98.2 number of problems attempted
Standard Deviation 56.11
|
76.4 number of problems attempted
Standard Deviation 47.74
|
|
PERM-P Scores - Number of Problems Attempted
10.0 hours post-dose
|
95.2 number of problems attempted
Standard Deviation 55.53
|
76.3 number of problems attempted
Standard Deviation 45.27
|
SECONDARY outcome
Timeframe: 0.75, 2, 4, 6, 8, and 10 hours post-dosePopulation: ITT
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).
Outcome measures
| Measure |
AR11 (Amphetamine Sulfate)
n=95 Participants
AR11, administered orally, BID, 10-40 mg/day
|
Placebo
n=97 Participants
Placebo, administered orally, BID
|
|---|---|---|
|
PERM-P Scores - Number of Problems Correct
8.0 hours post-dose
|
92.7 number of problems correct
Standard Deviation 57.28
|
71.5 number of problems correct
Standard Deviation 47.43
|
|
PERM-P Scores - Number of Problems Correct
0.75 hours post-dose
|
104.5 number of problems correct
Standard Deviation 54.49
|
83.9 number of problems correct
Standard Deviation 46.96
|
|
PERM-P Scores - Number of Problems Correct
2.0 hours post-dose
|
107.1 number of problems correct
Standard Deviation 53.15
|
78.9 number of problems correct
Standard Deviation 44.62
|
|
PERM-P Scores - Number of Problems Correct
4.0 hours post-dose
|
107.0 number of problems correct
Standard Deviation 57.46
|
79.9 number of problems correct
Standard Deviation 45.56
|
|
PERM-P Scores - Number of Problems Correct
6.0 hours post-dose
|
95.6 number of problems correct
Standard Deviation 55.43
|
70.5 number of problems correct
Standard Deviation 43.23
|
|
PERM-P Scores - Number of Problems Correct
10.0 hours post-dose
|
89.9 number of problems correct
Standard Deviation 55.29
|
72.3 number of problems correct
Standard Deviation 45.19
|
Adverse Events
AR11
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AR11
n=97 participants at risk
AR11, administered orally, BID for one week
|
Placebo
n=97 participants at risk
Placebo, administered orally, BID for one week
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
3.1%
3/97 • Number of events 3 • 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)
|
0.00%
0/97 • 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)
|
|
Psychiatric disorders
Mood swings
|
2.1%
2/97 • Number of events 2 • 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)
|
0.00%
0/97 • 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)
|
|
Gastrointestinal disorders
Upper abdominal pain
|
3.1%
3/97 • Number of events 3 • 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)
|
0.00%
0/97 • 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)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.1%
4/97 • Number of events 4 • 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)
|
0.00%
0/97 • 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)
|
|
Infections and infestations
Upper respiratory tract infection
|
1.0%
1/97 • Number of events 1 • 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)
|
2.1%
2/97 • Number of events 2 • 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)
|
|
Injury, poisoning and procedural complications
Contusion
|
2.1%
2/97 • Number of events 2 • 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)
|
0.00%
0/97 • 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)
|
|
Cardiac disorders
Tachycardia
|
2.1%
2/97 • Number of events 2 • 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)
|
3.1%
3/97 • Number of events 3 • 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)
|
|
Investigations
Decreased weight
|
2.1%
2/97 • Number of events 2 • 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)
|
1.0%
1/97 • Number of events 1 • 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)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60