Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years of Age With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting. (NCT NCT02734693)
NCT ID: NCT02734693
Last Updated: 2020-03-27
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
132 participants
Baseline to Day 15
2020-03-27
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo capsule
|
Dasotraline 4mg
Dasotraline capsule 4mg/day
|
Dasotraline 6mg
Dasotraline capsule 6mg/day
|
|---|---|---|---|
|
Overall Study
STARTED
|
56
|
56
|
20
|
|
Overall Study
COMPLETED
|
50
|
53
|
17
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Placebo capsule
|
Dasotraline 4mg
Dasotraline capsule 4mg/day
|
Dasotraline 6mg
Dasotraline capsule 6mg/day
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years of Age With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.
Baseline characteristics by cohort
| Measure |
Placebo
n=56 Participants
Placebo capsule
|
Dasotraline 4mg
n=56 Participants
Dasotraline capsule 4mg/day
|
Dasotraline 6mg
n=20 Participants
Dasotraline capsule 6mg/day
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
56 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
9.7 years
STANDARD_DEVIATION 1.86 • n=5 Participants
|
9.3 years
STANDARD_DEVIATION 1.76 • n=7 Participants
|
9.9 years
STANDARD_DEVIATION 1.69 • n=5 Participants
|
9.6 years
STANDARD_DEVIATION 1.8 • n=4 Participants
|
|
Age, Customized
6-9 years
|
24 participants
n=5 Participants
|
30 participants
n=7 Participants
|
7 participants
n=5 Participants
|
61 participants
n=4 Participants
|
|
Age, Customized
10-12 years
|
32 participants
n=5 Participants
|
26 participants
n=7 Participants
|
13 participants
n=5 Participants
|
71 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=5 Participants
|
56 participants
n=7 Participants
|
20 participants
n=5 Participants
|
132 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 15Population: intent to treat population, placebo and dasotraline 4mg. The dasotraline 6mg arm was discontinued after 20 subjects were enrolled and no data were collected for this Arm/Group
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=51 Participants
Placebo capsule
|
Dasotraline 4mg
n=52 Participants
Dasotraline capsule 4mg/day
|
Dasotraline 6mg
Dasotraline capsule 6mg/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)
|
1.99 Units on a scale
Standard Error 0.949
|
-3.19 Units on a scale
Standard Error 0.942
|
—
|
SECONDARY outcome
Timeframe: Baseline to Day 15Population: intent to treat population, placebo and dasotraline 4mg. The dasotraline 6mg arm was discontinued after 20 subjects were enrolled and no data were collected for this Arm/Group
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=51 Participants
Placebo capsule
|
Dasotraline 4mg
n=52 Participants
Dasotraline capsule 4mg/day
|
Dasotraline 6mg
Dasotraline capsule 6mg/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)
|
0.79 units on a scale
Standard Error 0.281
|
-0.67 units on a scale
Standard Error 0.279
|
—
|
SECONDARY outcome
Timeframe: Baseline to Day 15Population: intent to treat population, placebo and dasotraline 4mg. The dasotraline 6mg arm was discontinued after 20 subjects were enrolled and no data were collected for this Arm/Group
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=51 Participants
Placebo capsule
|
Dasotraline 4mg
n=52 Participants
Dasotraline capsule 4mg/day
|
Dasotraline 6mg
Dasotraline capsule 6mg/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)
|
0.16 units on a scale
Standard Error 0.356
|
-1.44 units on a scale
Standard Error 0.350
|
—
|
SECONDARY outcome
Timeframe: Baseline to Day 15Population: intent to treat population, placebo and dasotraline 4mg. The dasotraline 6mg arm was discontinued after 20 subjects were enrolled and no data were collected for this Arm/Group
TThe 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=51 Participants
Placebo capsule
|
Dasotraline 4mg
n=52 Participants
Dasotraline capsule 4mg/day
|
Dasotraline 6mg
Dasotraline capsule 6mg/day
|
|---|---|---|---|
|
Change From Baseline at Day 15 in Permanent Product Measure of Performance (PERMP)-Attempted and Correct Problems Scores Obtained From the 7 Assessments Collected Over the 12-hour Classroom Day (12-24-hours Postdose)
attempted
|
-1.07 units on a scale
Standard Error 5.871
|
22.60 units on a scale
Standard Error 5.780
|
—
|
|
Change From Baseline at Day 15 in Permanent Product Measure of Performance (PERMP)-Attempted and Correct Problems Scores Obtained From the 7 Assessments Collected Over the 12-hour Classroom Day (12-24-hours Postdose)
corrected
|
-1.96 units on a scale
Standard Error 5.864
|
22.09 units on a scale
Standard Error 5.777
|
—
|
Adverse Events
Placebo
Dasotraline 4mg
Dasotraline 6mg
Serious adverse events
| Measure |
Placebo
n=56 participants at risk
Placebo capsule
|
Dasotraline 4mg
n=56 participants at risk
Dasotraline capsule 4mg/day
|
Dasotraline 6mg
n=20 participants at risk
Dasotraline capsule 6mg/day
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.8%
1/56 • Number of events 1 • 3 weeks
|
0.00%
0/56 • 3 weeks
|
0.00%
0/20 • 3 weeks
|
Other adverse events
| Measure |
Placebo
n=56 participants at risk
Placebo capsule
|
Dasotraline 4mg
n=56 participants at risk
Dasotraline capsule 4mg/day
|
Dasotraline 6mg
n=20 participants at risk
Dasotraline capsule 6mg/day
|
|---|---|---|---|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
0.00%
0/56 • 3 weeks
|
5.4%
3/56 • Number of events 3 • 3 weeks
|
0.00%
0/20 • 3 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/56 • 3 weeks
|
1.8%
1/56 • Number of events 1 • 3 weeks
|
10.0%
2/20 • Number of events 2 • 3 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/56 • 3 weeks
|
1.8%
1/56 • Number of events 1 • 3 weeks
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/56 • Number of events 1 • 3 weeks
|
0.00%
0/56 • 3 weeks
|
10.0%
2/20 • Number of events 2 • 3 weeks
|
|
General disorders
Fatigue
|
3.6%
2/56 • Number of events 2 • 3 weeks
|
0.00%
0/56 • 3 weeks
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
|
Infections and infestations
Oral herpes
|
0.00%
0/56 • 3 weeks
|
0.00%
0/56 • 3 weeks
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/56 • 3 weeks
|
0.00%
0/56 • 3 weeks
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
|
Investigations
Weight decreased
|
0.00%
0/56 • 3 weeks
|
1.8%
1/56 • Number of events 1 • 3 weeks
|
10.0%
2/20 • Number of events 2 • 3 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.6%
2/56 • Number of events 2 • 3 weeks
|
10.7%
6/56 • Number of events 6 • 3 weeks
|
20.0%
4/20 • Number of events 4 • 3 weeks
|
|
Musculoskeletal and connective tissue disorders
Musle spasms
|
0.00%
0/56 • 3 weeks
|
0.00%
0/56 • 3 weeks
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
|
Nervous system disorders
Dizziness postural
|
1.8%
1/56 • Number of events 1 • 3 weeks
|
0.00%
0/56 • 3 weeks
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
|
Nervous system disorders
Headache
|
8.9%
5/56 • Number of events 6 • 3 weeks
|
10.7%
6/56 • Number of events 6 • 3 weeks
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
|
Psychiatric disorders
Affect lability
|
7.1%
4/56 • Number of events 4 • 3 weeks
|
8.9%
5/56 • Number of events 5 • 3 weeks
|
20.0%
4/20 • Number of events 4 • 3 weeks
|
|
Psychiatric disorders
Delusion
|
0.00%
0/56 • 3 weeks
|
0.00%
0/56 • 3 weeks
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
|
Psychiatric disorders
Emotional poverty
|
0.00%
0/56 • 3 weeks
|
0.00%
0/56 • 3 weeks
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
|
Psychiatric disorders
Hallucination tactile
|
0.00%
0/56 • 3 weeks
|
1.8%
1/56 • Number of events 1 • 3 weeks
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
|
Psychiatric disorders
Hallucination visual
|
0.00%
0/56 • 3 weeks
|
1.8%
1/56 • Number of events 1 • 3 weeks
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
|
Psychiatric disorders
Initial insomnia
|
1.8%
1/56 • Number of events 1 • 3 weeks
|
5.4%
3/56 • Number of events 3 • 3 weeks
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
|
Psychiatric disorders
Insomnia
|
1.8%
1/56 • Number of events 1 • 3 weeks
|
12.5%
7/56 • Number of events 8 • 3 weeks
|
25.0%
5/20 • Number of events 5 • 3 weeks
|
|
Psychiatric disorders
Irritability
|
3.6%
2/56 • Number of events 2 • 3 weeks
|
5.4%
3/56 • Number of events 3 • 3 weeks
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/56 • 3 weeks
|
0.00%
0/56 • 3 weeks
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
|
Psychiatric disorders
Tic
|
0.00%
0/56 • 3 weeks
|
1.8%
1/56 • Number of events 1 • 3 weeks
|
5.0%
1/20 • Number of events 1 • 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