Trial Outcomes & Findings for Dasotraline Pediatric Extension Study (NCT NCT02457819)
NCT ID: NCT02457819
Last Updated: 2020-01-28
Results Overview
Overall adverse events, AEs , serious adverse envents,(or SAEs), and AEs (or SAEs) leading to discontinuation.
COMPLETED
PHASE3
237 participants
26 Weeks
2020-01-28
Participant Flow
Participant milestones
| Measure |
Dasotraline
Dasotraline 2, 4, 6 mg, flexibly dosed
|
|---|---|
|
Overall Study
STARTED
|
237
|
|
Overall Study
Safety Population
|
236
|
|
Overall Study
COMPLETED
|
138
|
|
Overall Study
NOT COMPLETED
|
99
|
Reasons for withdrawal
| Measure |
Dasotraline
Dasotraline 2, 4, 6 mg, flexibly dosed
|
|---|---|
|
Overall Study
reason not given
|
8
|
|
Overall Study
Withdrawal by Subject
|
24
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
non compliance with study drug
|
4
|
|
Overall Study
Lost to Follow-up
|
10
|
|
Overall Study
Lack of Efficacy
|
19
|
|
Overall Study
Adverse Event
|
33
|
Baseline Characteristics
Dasotraline Pediatric Extension Study
Baseline characteristics by cohort
| Measure |
Dasotraline
n=236 Participants
Dasotraline 2, 4, 6 mg, flexibly dosed
|
|---|---|
|
Age, Categorical
<=18 years
|
236 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
160 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
199 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
71 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
146 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
236 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 26 WeeksPopulation: safety population
Overall adverse events, AEs , serious adverse envents,(or SAEs), and AEs (or SAEs) leading to discontinuation.
Outcome measures
| Measure |
Dasotraline
n=236 Participants
Dasotraline 2, 4, 6 mg, flexibly dosed
|
|---|---|
|
The Incidence of Overall Adverse Events, AEs , Serious Adverse Envents,(or SAEs), and AEs (or SAEs) Leading to Discontinuation
Subjects with any TEAE
|
144 adverse events
|
|
The Incidence of Overall Adverse Events, AEs , Serious Adverse Envents,(or SAEs), and AEs (or SAEs) Leading to Discontinuation
Subjects with any TEAE leading to discontinuation
|
30 adverse events
|
|
The Incidence of Overall Adverse Events, AEs , Serious Adverse Envents,(or SAEs), and AEs (or SAEs) Leading to Discontinuation
Subjects with any serious TEAE
|
3 adverse events
|
|
The Incidence of Overall Adverse Events, AEs , Serious Adverse Envents,(or SAEs), and AEs (or SAEs) Leading to Discontinuation
Subjects with any serious treatment-related TEAE
|
1 adverse events
|
|
The Incidence of Overall Adverse Events, AEs , Serious Adverse Envents,(or SAEs), and AEs (or SAEs) Leading to Discontinuation
treatment-related TEAE leading to discontinuation
|
1 adverse events
|
SECONDARY outcome
Timeframe: 26 WeeksPopulation: safety population
The ADHD RS-IV HV is a validated scale that consists of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria and is also consistent with DSM-5 criteria. Each item is scored from a range of zero (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from zero to 54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (even number items 2 through 18) and inattentiveness (odd number items 1 through 17).
Outcome measures
| Measure |
Dasotraline
n=138 Participants
Dasotraline 2, 4, 6 mg, flexibly dosed
|
|---|---|
|
Change From Baseline, in Attention Deficit Hyperactivity Disorder Rating Scale, Version IV, Home Version, (ADHD RS IV HV) Total Score.
|
-7.1 units on a scale
Standard Deviation 10.19
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: safety population
The CGI-S scale, modified captures the clinician's rating of observed and reported ADHD symptoms, behavior, and function over the past 7 days. The CGI-S is rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill subjects.
Outcome measures
| Measure |
Dasotraline
n=139 Participants
Dasotraline 2, 4, 6 mg, flexibly dosed
|
|---|---|
|
Change From Baseline, in Clinical Global Impression-Severity of Illness (CGI S) Score.
|
-0.6 units on a scale
Standard Deviation 1.11
|
Adverse Events
Dasotraline
Serious adverse events
| Measure |
Dasotraline
n=236 participants at risk
Dasotraline 2, 4, 6 mg, flexibly dosed
|
|---|---|
|
Infections and infestations
Pyelonephritis
|
0.42%
1/236 • Number of events 1 • 26 weeks
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.42%
1/236 • Number of events 1 • 26 weeks
|
|
Psychiatric disorders
Anxiety
|
0.42%
1/236 • Number of events 1 • 26 weeks
|
|
Product Issues
Panic attack
|
0.42%
1/236 • Number of events 1 • 26 weeks
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.42%
1/236 • Number of events 1 • 26 weeks
|
|
Psychiatric disorders
Suicidal ideatin
|
0.42%
1/236 • Number of events 1 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.42%
1/236 • Number of events 1 • 26 weeks
|
Other adverse events
| Measure |
Dasotraline
n=236 participants at risk
Dasotraline 2, 4, 6 mg, flexibly dosed
|
|---|---|
|
Investigations
Weight decreased
|
12.3%
29/236 • Number of events 30 • 26 weeks
|
|
Metabolism and nutrition disorders
Decreased apppetite
|
20.8%
49/236 • Number of events 56 • 26 weeks
|
|
Nervous system disorders
Headache
|
11.0%
26/236 • Number of events 31 • 26 weeks
|
|
Nervous system disorders
Anxiety
|
5.5%
13/236 • Number of events 15 • 26 weeks
|
|
Nervous system disorders
Initial insomnia
|
11.0%
26/236 • Number of events 30 • 26 weeks
|
|
Nervous system disorders
Irritability
|
8.5%
20/236 • Number of events 22 • 26 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