Trial Outcomes & Findings for A Study of the Efficacy of Botox in the Treatment of Social Anxiety Disorder (NCT NCT03078270)
NCT ID: NCT03078270
Last Updated: 2019-01-23
Results Overview
Repeated measure at baseline, 4-weeks and 8-weeks post-injection of anxiety using the Liebowitz Social Anxiety Scale to determine treatment response.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
4 participants
Primary outcome timeframe
2 months
Results posted on
2019-01-23
Participant Flow
Participant milestones
| Measure |
Open-label
4 participants were recruited for the open-label study.
|
Double-Blind
0 participants were recruited for the double-blind, comparison study.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Efficacy of Botox in the Treatment of Social Anxiety Disorder
Baseline characteristics by cohort
| Measure |
Open-label
n=4 Participants
4 participants were recruited with social anxiety disorder.
|
Double-Blind
No participants were recruited.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
—
|
4 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: The study was closed before outcome measures were collected.
Repeated measure at baseline, 4-weeks and 8-weeks post-injection of anxiety using the Liebowitz Social Anxiety Scale to determine treatment response.
Outcome measures
Outcome data not reported
Adverse Events
Open-label
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Double-Blind
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place