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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03231800
Recruitment Status : Completed
First Posted : July 27, 2017
Results First Posted : June 24, 2020
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Sunovion

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Attention-Deficit Hyperactivity Disorder (ADHD)
Interventions Drug: dasotraline
Drug: Placebo
Enrollment 95
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Dasotraline
Hide Arm/Group Description Placebo capsule Dasotraline capsule 2mg/day
Period Title: Overall Study
Started 48 47
Safety Population 47 47
Completed 45 44
Not Completed 3 3
Reason Not Completed
Lost to Follow-up             0             2
Protocol Violation             1             1
reason not provided             2             0
Arm/Group Title Placebo Dasotraline Total
Hide Arm/Group Description Placebo capsule Dasotraline capsule 2mg/day Total of all reporting groups
Overall Number of Baseline Participants 47 47 94
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 47 participants 94 participants
<=18 years
47
 100.0%
47
 100.0%
94
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 47 participants 94 participants
7.4  (1.17) 7.5  (1.21) 7.5  (1.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 47 participants 94 participants
Female
13
  27.7%
18
  38.3%
31
  33.0%
Male
34
  72.3%
29
  61.7%
63
  67.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 47 participants 94 participants
Hispanic or Latino
14
  29.8%
11
  23.4%
25
  26.6%
Not Hispanic or Latino
33
  70.2%
36
  76.6%
69
  73.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 47 participants 94 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
15
  31.9%
3
   6.4%
18
  19.1%
White
28
  59.6%
0
   0.0%
28
  29.8%
More than one race
4
   8.5%
11
  23.4%
15
  16.0%
Unknown or Not Reported
0
   0.0%
33
  70.2%
33
  35.1%
Height (cm)  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 47 participants 47 participants 94 participants
125.1  (8.37) 127.3  (6.95) 126.2  (7.74)
Weight (kg)  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 47 participants 47 participants 94 participants
24.9  (3.35) 25.6  (3.8) 25.3  (3.57)
BMI (kg/m^2)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 47 participants 47 participants 94 participants
15.92  (1.185) 15.68  (1.261) 15.8  (1.223)
Baseline Averaged Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale - CS  
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 47 participants 47 participants 94 participants
26.23  (12.15) 24.61  (13.362) 25.42  (12.727)
Baseline Averaged Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale ( - Attention Subscale Score  
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 47 participants 47 participants 94 participants
5.07  (3.323) 4.74  (3.562) 4.91  (3.43)
Baseline Averaged Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale ( - Deportment Subscale Score  
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 47 participants 47 participants 94 participants
6.7  (4.729) 6.4  (4.807) 6.55  (4.745)
Baseline Averaged Permanent Product Measure of Performance (PERMP) - Problems Attempted  
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 47 participants 47 participants 94 participants
68.09  (36.173) 79.62  (47.008) 73.85  (42.116)
Baseline Averaged Permanent Product Measure of Performance (PERMP)- Problems Correct  
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 47 participants 47 participants 94 participants
60.36  (37.26) 76.41  (47.42) 68.39  (43.173)
1.Primary Outcome
Title 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)
Hide Description 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.
Time Frame Baseline to Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat population
Arm/Group Title Placebo Dasotraline
Hide Arm/Group Description:
Placebo capsule
Dasotraline capsule 2mg/day
Overall Number of Participants Analyzed 45 45
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
1.57  (0.773) -3.67  (0.775)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dasotraline
Comments Least squares means, SEs, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), mean SKAMP-CS at baseline, and site as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.24
Confidence Interval (2-Sided) 95%
-7.351 to -3.137
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.059
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Baseline to Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat population
Arm/Group Title Placebo Dasotraline
Hide Arm/Group Description:
Placebo capsule
Dasotraline capsule 2mg/day
Overall Number of Participants Analyzed 45 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.10  (0.293) -0.27  (0.294)
3.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Baseline to Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat population
Arm/Group Title Placebo Dasotraline
Hide Arm/Group Description:
Placebo capsule
Dasotraline capsule 2mg/day
Overall Number of Participants Analyzed 45 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.50  (0.304) -1.78  (0.306)
4.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Baseline to Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat population
Arm/Group Title Placebo Dasotraline
Hide Arm/Group Description:
Placebo capsule
Dasotraline capsule 2mg/day
Overall Number of Participants Analyzed 45 45
Least Squares Mean (Standard Error)
Unit of Measure: problems
3.51  (4.128) 17.37  (4.074)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dasotraline
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 13.86
Confidence Interval (2-Sided) 95%
2.694 to 25.017
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.612
Estimation Comments [Not Specified]
5.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Baseline to Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat population
Arm/Group Title Placebo Dasotraline
Hide Arm/Group Description:
Placebo capsule
Dasotraline capsule 2mg/day
Overall Number of Participants Analyzed 45 45
Least Squares Mean (Standard Error)
Unit of Measure: problems
5.47  (4.047) 17.53  (3.979)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dasotraline
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 12.06
Confidence Interval (2-Sided) 95%
1.105 to 23.017
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.508
Estimation Comments [Not Specified]
Time Frame 3 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Dasotraline
Hide Arm/Group Description Placebo capsule Dasotraline capsule 2mg/day
All-Cause Mortality
Placebo Dasotraline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)      0/47 (0.00%)    
Hide Serious Adverse Events
Placebo Dasotraline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/47 (0.00%)      0/47 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Dasotraline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/47 (4.26%)      6/47 (12.77%)    
Gastrointestinal disorders     
Vomiting  1  1/47 (2.13%)  1 3/47 (6.38%)  3
Psychiatric disorders     
Insomnia  1  1/47 (2.13%)  1 4/47 (8.51%)  4
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: CNS Medical Director
Organization: Sunovion Pharmaceuticals Inc.
Phone: 1-866-503-6351
EMail: ClinicalTrialDisclosure@sunovion.com
Layout table for additonal information
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT03231800    
Other Study ID Numbers: SEP-360-311
First Submitted: July 24, 2017
First Posted: July 27, 2017
Results First Submitted: June 4, 2020
Results First Posted: June 24, 2020
Last Update Posted: July 8, 2020