Trial Outcomes & Findings for SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP) (NCT NCT01470469)
NCT ID: NCT01470469
Last Updated: 2021-06-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
83 participants
Primary outcome timeframe
Baseline and up to 12 weeks
Results posted on
2021-06-10
Participant Flow
Participant milestones
| Measure |
PLACEBO
Once-daily oral dosing in the evening for 12 weeks.
|
SPD503
Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
62
|
|
Overall Study
COMPLETED
|
11
|
38
|
|
Overall Study
NOT COMPLETED
|
10
|
24
|
Reasons for withdrawal
| Measure |
PLACEBO
Once-daily oral dosing in the evening for 12 weeks.
|
SPD503
Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
|
Overall Study
Lack of Efficacy
|
1
|
7
|
|
Overall Study
Adverse Event
|
0
|
7
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Other
|
2
|
1
|
Baseline Characteristics
SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP)
Baseline characteristics by cohort
| Measure |
PLACEBO
n=21 Participants
Once-daily oral dosing in the evening for 12 weeks.
|
SPD503
n=62 Participants
Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.8 Years
STANDARD_DEVIATION 3.46 • n=5 Participants
|
11.7 Years
STANDARD_DEVIATION 3.39 • n=7 Participants
|
11.7 Years
STANDARD_DEVIATION 3.38 • n=5 Participants
|
|
Age, Customized
Age 6-12 years
|
12 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Customized
Age 13-17 years
|
9 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
UNITED STATES
|
21 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to 12 weeksPopulation: Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Outcome measures
| Measure |
PLACEBO
n=19 Participants
Once-daily oral dosing in the evening for 12 weeks.
|
SPD503
n=59 Participants
Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure at Up to 12 Weeks
|
-1.7 mmHg
Standard Deviation 11.18
|
-2.3 mmHg
Standard Deviation 11.40
|
PRIMARY outcome
Timeframe: Baseline and up to 12 weeksPopulation: Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Outcome measures
| Measure |
PLACEBO
n=19 Participants
Once-daily oral dosing in the evening for 12 weeks.
|
SPD503
n=59 Participants
Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure at Up to 12 Weeks
|
0.9 mmHg
Standard Deviation 7.37
|
-1.3 mmHg
Standard Deviation 9.09
|
PRIMARY outcome
Timeframe: Baseline and up to 12 weeksPopulation: Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Outcome measures
| Measure |
PLACEBO
n=19 Participants
Once-daily oral dosing in the evening for 12 weeks.
|
SPD503
n=59 Participants
Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Pulse Rate at Up to 12 Weeks
|
-0.5 beats/min
Standard Deviation 11.09
|
-1.8 beats/min
Standard Deviation 11.54
|
PRIMARY outcome
Timeframe: Baseline and up to 12 weeksPopulation: Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Outcome measures
| Measure |
PLACEBO
n=19 Participants
Once-daily oral dosing in the evening for 12 weeks.
|
SPD503
n=59 Participants
Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Height at up to 12 Weeks
|
0.5 cm
Standard Deviation 0.91
|
1.0 cm
Standard Deviation 1.79
|
PRIMARY outcome
Timeframe: Baseline and up to 12 weeksPopulation: Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Outcome measures
| Measure |
PLACEBO
n=19 Participants
Once-daily oral dosing in the evening for 12 weeks.
|
SPD503
n=59 Participants
Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Weight at up to 12 Weeks
|
0.7 kg
Standard Deviation 1.73
|
1.3 kg
Standard Deviation 1.57
|
PRIMARY outcome
Timeframe: Baseline and up to 12 weeksPopulation: Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
QRS complex is a portion of the ECG tracing that represents depolarization of the ventricular myocardium.
Outcome measures
| Measure |
PLACEBO
n=19 Participants
Once-daily oral dosing in the evening for 12 weeks.
|
SPD503
n=55 Participants
Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Electrocardiogram (ECG) QRS Interval at up to 12 Weeks
|
0.7 msec
Standard Deviation 6.50
|
0.1 msec
Standard Deviation 5.33
|
PRIMARY outcome
Timeframe: Baseline and up to 12 weeksPopulation: Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
The QT interval is the time from the start of the Q wave to the end of the T wave. It is a portion of the ECG tracing that represents the time taken for ventricular depolarisation and repolarisation. The QTcF includes a correction factor to help account for changes in heart rate.
Outcome measures
| Measure |
PLACEBO
n=19 Participants
Once-daily oral dosing in the evening for 12 weeks.
|
SPD503
n=55 Participants
Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
|
|---|---|---|
|
Change From Baseline in ECG QTcF Interval at up to 12 Weeks
|
0.3 msec
Standard Deviation 9.38
|
4.1 msec
Standard Deviation 14.01
|
Adverse Events
PLACEBO
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
SPD503
Serious events: 0 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PLACEBO
n=21 participants at risk
Once-daily oral dosing in the evening for 12 weeks.
|
SPD503
n=62 participants at risk
Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.5%
2/21 • Number of events 2
|
16.1%
10/62 • Number of events 17
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/21
|
9.7%
6/62 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhoea
|
9.5%
2/21 • Number of events 2
|
6.5%
4/62 • Number of events 6
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/21
|
6.5%
4/62 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
9.5%
2/21 • Number of events 2
|
8.1%
5/62 • Number of events 5
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • Number of events 1
|
9.7%
6/62 • Number of events 7
|
|
General disorders
Fatigue
|
0.00%
0/21
|
21.0%
13/62 • Number of events 16
|
|
General disorders
Irritability
|
4.8%
1/21 • Number of events 1
|
6.5%
4/62 • Number of events 4
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/21
|
6.5%
4/62 • Number of events 4
|
|
Infections and infestations
Upper respiratory tract infection
|
9.5%
2/21 • Number of events 2
|
3.2%
2/62 • Number of events 3
|
|
Injury, poisoning and procedural complications
Joint sprain
|
14.3%
3/21 • Number of events 3
|
1.6%
1/62 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/21
|
9.7%
6/62 • Number of events 6
|
|
Metabolism and nutrition disorders
Increased appetite
|
9.5%
2/21 • Number of events 2
|
1.6%
1/62 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • Number of events 2
|
11.3%
7/62 • Number of events 8
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/21
|
11.3%
7/62 • Number of events 11
|
|
Nervous system disorders
Headache
|
19.0%
4/21 • Number of events 7
|
35.5%
22/62 • Number of events 26
|
|
Nervous system disorders
Sedation
|
9.5%
2/21 • Number of events 2
|
9.7%
6/62 • Number of events 7
|
|
Nervous system disorders
Somnolence
|
4.8%
1/21 • Number of events 2
|
27.4%
17/62 • Number of events 30
|
|
Psychiatric disorders
Initial insomnia
|
4.8%
1/21 • Number of events 1
|
6.5%
4/62 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.5%
2/21 • Number of events 2
|
4.8%
3/62 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER