Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years Old With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting. (NCT NCT03231800)
NCT ID: NCT03231800
Last Updated: 2020-07-08
Results Overview
The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The combined scores for the SKAMP are obtained by summing the values of all 13 items in the assessment. The range of SKAMP combined score is 0-78, with higher values represent a worse outcome.
COMPLETED
PHASE3
95 participants
Baseline to Day 15
2020-07-08
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo capsule
|
Dasotraline
Dasotraline capsule 2mg/day
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
47
|
|
Overall Study
Safety Population
|
47
|
47
|
|
Overall Study
COMPLETED
|
45
|
44
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Placebo capsule
|
Dasotraline
Dasotraline capsule 2mg/day
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
reason not provided
|
2
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years Old With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.
Baseline characteristics by cohort
| Measure |
Placebo
n=47 Participants
Placebo capsule
|
Dasotraline
n=47 Participants
Dasotraline capsule 2mg/day
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
47 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
7.4 Years
STANDARD_DEVIATION 1.17 • n=5 Participants
|
7.5 Years
STANDARD_DEVIATION 1.21 • n=7 Participants
|
7.5 Years
STANDARD_DEVIATION 1.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Height (cm)
|
125.1 cm
STANDARD_DEVIATION 8.37 • n=5 Participants
|
127.3 cm
STANDARD_DEVIATION 6.95 • n=7 Participants
|
126.2 cm
STANDARD_DEVIATION 7.74 • n=5 Participants
|
|
Weight (kg)
|
24.9 kg
STANDARD_DEVIATION 3.35 • n=5 Participants
|
25.6 kg
STANDARD_DEVIATION 3.8 • n=7 Participants
|
25.3 kg
STANDARD_DEVIATION 3.57 • n=5 Participants
|
|
BMI (kg/m^2)
|
15.92 kg/m^2
STANDARD_DEVIATION 1.185 • n=5 Participants
|
15.68 kg/m^2
STANDARD_DEVIATION 1.261 • n=7 Participants
|
15.8 kg/m^2
STANDARD_DEVIATION 1.223 • n=5 Participants
|
|
Baseline Averaged Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale - CS
|
26.23 Score
STANDARD_DEVIATION 12.15 • n=5 Participants
|
24.61 Score
STANDARD_DEVIATION 13.362 • n=7 Participants
|
25.42 Score
STANDARD_DEVIATION 12.727 • n=5 Participants
|
|
Baseline Averaged Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale ( - Attention Subscale Score
|
5.07 Score
STANDARD_DEVIATION 3.323 • n=5 Participants
|
4.74 Score
STANDARD_DEVIATION 3.562 • n=7 Participants
|
4.91 Score
STANDARD_DEVIATION 3.43 • n=5 Participants
|
|
Baseline Averaged Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale ( - Deportment Subscale Score
|
6.7 Score
STANDARD_DEVIATION 4.729 • n=5 Participants
|
6.4 Score
STANDARD_DEVIATION 4.807 • n=7 Participants
|
6.55 Score
STANDARD_DEVIATION 4.745 • n=5 Participants
|
|
Baseline Averaged Permanent Product Measure of Performance (PERMP) - Problems Attempted
|
68.09 Score
STANDARD_DEVIATION 36.173 • n=5 Participants
|
79.62 Score
STANDARD_DEVIATION 47.008 • n=7 Participants
|
73.85 Score
STANDARD_DEVIATION 42.116 • n=5 Participants
|
|
Baseline Averaged Permanent Product Measure of Performance (PERMP)- Problems Correct
|
60.36 Score
STANDARD_DEVIATION 37.26 • n=5 Participants
|
76.41 Score
STANDARD_DEVIATION 47.42 • n=7 Participants
|
68.39 Score
STANDARD_DEVIATION 43.173 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 15Population: intent to treat population
The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The combined scores for the SKAMP are obtained by summing the values of all 13 items in the assessment. The range of SKAMP combined score is 0-78, with higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=45 Participants
Placebo capsule
|
Dasotraline
n=45 Participants
Dasotraline capsule 2mg/day
|
|---|---|---|
|
Change From Baseline at Day 15 in , ADHD Symptoms as Measured by Mean Swanson,Kotkin,Agler,M-Flynn, Pelham Rating Scale(SKAMP)-Combined Score Obtained From an Average of the 7 Assessments Collected Across the 12-hour Classroom Day(12 to 24 Hours Postdose)
|
1.57 Units on a scale
Standard Error 0.773
|
-3.67 Units on a scale
Standard Error 0.775
|
SECONDARY outcome
Timeframe: Baseline to Day 15Population: intent to treat population
The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The Attention Subscale scores for the SKAMP are obtained by summing the values of Items 1-4 in the assessment. The range of SKAMP Attention Subscale score is 0-24, with higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=45 Participants
Placebo capsule
|
Dasotraline
n=45 Participants
Dasotraline capsule 2mg/day
|
|---|---|---|
|
Change From Baseline at Day 15 in Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)Attention Subscale Score Obtained From the 7 Assessments Collected Across the 12-hour Classroom Day (12 to 24 Hours Postdose)
|
1.10 units on a scale
Standard Error 0.293
|
-0.27 units on a scale
Standard Error 0.294
|
SECONDARY outcome
Timeframe: Baseline to Day 15Population: intent to treat population
The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The Deportment Subscale scores for the SKAMP are obtained by summing the values of Items 5-8 in the assessment. The range of SKAMP Deportment Subscale score is 0-24, with higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=45 Participants
Placebo capsule
|
Dasotraline
n=45 Participants
Dasotraline capsule 2mg/day
|
|---|---|---|
|
Change From Baseline at Day 15 in Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Deportment Subscale Score Obtained From the 7 Assessments Collected Across the 12-hour Classroom Day (12 to 24 Hours Postdose)
|
0.50 units on a scale
Standard Error 0.304
|
-1.78 units on a scale
Standard Error 0.306
|
SECONDARY outcome
Timeframe: Baseline to Day 15Population: intent to treat population
The Permanent Product Measure of Performance (PERMP) is a math test consisting of 400 problems. Both attempted problems and correct problems are assessed. Subjects are to complete as many problems as possible in 10 minutes. Performance is measured by the number of math problems attempted and the number of math problems correctly completed. The minimum possible score is 0. The highest possible score is 400, with higher scores mean higher performance and less severe ADHD symptoms.
Outcome measures
| Measure |
Placebo
n=45 Participants
Placebo capsule
|
Dasotraline
n=45 Participants
Dasotraline capsule 2mg/day
|
|---|---|---|
|
Change From Baseline at Day 15 in Mean Permanent Product Measure of Performance (PERMP)-Attempted Problems Scores Obtained From the 7 Assessments Collected Over the 12-hour Classroom Day (12-24-hours Postdose)
|
3.51 problems
Standard Error 4.128
|
17.37 problems
Standard Error 4.074
|
SECONDARY outcome
Timeframe: Baseline to Day 15Population: intent to treat population
The Permanent Product Measure of Performance (PERMP) is a math test consisting of 400 problems. Both attempted problems and correct problems are assessed. Subjects are to complete as many problems as possible in 10 minutes. Performance is measured by the number of math problems attempted and the number of math problems correctly completed. The minimum possible score is 0. The highest possible score is 400, with higher scores mean higher performance and less severe ADHD symptoms.
Outcome measures
| Measure |
Placebo
n=45 Participants
Placebo capsule
|
Dasotraline
n=45 Participants
Dasotraline capsule 2mg/day
|
|---|---|---|
|
Change From Baseline at Day 15 in Mean Permanent Product Measure of Performance (PERMP)-Correct Problems Scores Obtained From the 7 Assessments Collected Over the 12-hour Classroom Day (12-24-hours Postdose)
|
5.47 problems
Standard Error 4.047
|
17.53 problems
Standard Error 3.979
|
Adverse Events
Placebo
Dasotraline
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=47 participants at risk
Placebo capsule
|
Dasotraline
n=47 participants at risk
Dasotraline capsule 2mg/day
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/47 • Number of events 1 • 3 weeks
|
6.4%
3/47 • Number of events 3 • 3 weeks
|
|
Psychiatric disorders
Insomnia
|
2.1%
1/47 • Number of events 1 • 3 weeks
|
8.5%
4/47 • Number of events 4 • 3 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER