Trial Outcomes & Findings for Acute Anxiolytic Effects of Riluzole on Subjects With Social Anxiety Disorder (NCT NCT03017508)
NCT ID: NCT03017508
Last Updated: 2021-05-20
Results Overview
Measure Description: In the Visual Analogue Scale (VAS) participants are presented with a straight horizontal line of 100 mm in length and asked to mark the placement that would best describe the intensity of the anxiety felt at that moment. The left end (0mm) represents "no anxiety" and the right end (100mm) represents "the worst anxiety ever felt" by the participant.The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks, generating a numerical score along a continuum
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
22 participants
Primary outcome timeframe
up to 60 minutes
Results posted on
2021-05-20
Participant Flow
28 participants were screened in person at the Yale Child Study Center. Of these, 22 were enrolled and 6 were excluded (2 did not have a diagnosis of Public Speaking Anxiety, 3 had a positive utox and 1 had uncontrolled hypertension).
Participant milestones
| Measure |
Participants Randomized to BHV-0223 First and After a Washout Period of 2-10 Days Received Placebo
Participants that were randomized to receive sublingual BHV-0223 before performing a 10 minute speech task and were then followed for 3 hours. Participants were then assessed every hour for the next three hours. There was a 2 to 10 days of washout period. These participants would then receive an identical looking sublingual placebo before performing a 10 minute speech task and were followed for 3 hours.
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Participants Randomized to Placebo First and After a Washout Period of 2-10 Days Received BHV-0223
Participants that were randomized to receive sublingual placebo before performing a 10 minute speech task and were then followed for 3 hours. Participants were then assessed every hour for the next three hours. There was a 2 to 10 days of washout period. These participants would then receive sublingual BHV-0223 before performing a 10 minute speech task and were followed for 3 hours.
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|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
|
Overall Study
First Intervention (1 Day)
|
12
|
10
|
|
Overall Study
Washout (2-10 Days)
|
12
|
10
|
|
Overall Study
Second Intervention (1 Day)
|
12
|
10
|
|
Overall Study
COMPLETED
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acute Anxiolytic Effects of Riluzole on Subjects With Social Anxiety Disorder
Baseline characteristics by cohort
| Measure |
Participants That Were Randomized to Receive BHV-0223 (Sublingual Riluzole) First
n=12 Participants
Participants were given one dose of BHV-0223 (sublingual riluzole) 35mg before performing a 10 minute speech task. Participants will then be assessed every hour for the next three hours. There will be 2 to 10 days of washout period between the randomly assigned arms of the study.
BHV-0223: 35mg of sublingual riluzole before performing an anxiety provoking speech task. Participants will then be clinically assessed every hour for 3 hours.
|
Participants That Were Randomized to Receive Placebo First
n=10 Participants
Participants were given one dose of an identical looking sublingual placebo before performing a 10 minute speech task. Participants will then be assessed every hour for the next three hours. There will be 2 to 10 days of washout period between the randomly assigned arms of the study.
Placebo: a sublingual tablet identical to the active drug will be given before performing an anxiety provoking speech task. Participants will then be clinically assessed every hour for three hours.
|
Total
n=22 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34 years
n=5 Participants
|
29 years
n=7 Participants
|
31.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Visual Analogue Scale Baseline Score
|
62.25 millimeters
STANDARD_DEVIATION 17.05 • n=5 Participants
|
46.6 millimeters
STANDARD_DEVIATION 22.5 • n=7 Participants
|
55.1 millimeters
STANDARD_DEVIATION 20.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: up to 60 minutesMeasure Description: In the Visual Analogue Scale (VAS) participants are presented with a straight horizontal line of 100 mm in length and asked to mark the placement that would best describe the intensity of the anxiety felt at that moment. The left end (0mm) represents "no anxiety" and the right end (100mm) represents "the worst anxiety ever felt" by the participant.The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks, generating a numerical score along a continuum
Outcome measures
| Measure |
BHV-0223 (Sublingual Riluzole)
n=22 Participants
Participants will be given one dose of BHV-0223 (sublingual riluzole) 35mg before performing a 10 minute speech task. Participants will then be assessed immediately after finishing speech task.
BHV-0223: 35mg of sublingual riluzole before performing an anxiety provoking speech task. Participants will then be clinically assessed immediately after finishing the speech task.
|
Placebo
n=22 Participants
Participants will be given one dose of an identical looking sublingual placebo before performing a 10 minute speech task. Participants will then be assessed immediately after finishing the speech task.
Placebo: a sublingual tablet identical to the active drug will be given before performing an anxiety provoking speech task. Participants will then be clinically assessed immediately after finishing the speech task.
|
|---|---|---|
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VAS-anxiety Immediately After the Impromptu Speech Task
|
54.3 millimeters (units on a scale)
Standard Deviation 23.6
|
62.6 millimeters (units on a scale)
Standard Deviation 13.7
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Adverse Events
BHV-0223 (Sublingual Riluzole)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BHV-0223 (Sublingual Riluzole)
n=22 participants at risk
Participants will be given one dose of BHV-0223 (sublingual riluzole) 35mg before performing a 10 minute speech task. Participants will then be assessed immediately after finishing speech task.
BHV-0223: 35mg of sublingual riluzole before performing an anxiety provoking speech task. Participants will then be clinically assessed immediately after finishing the speech task.
|
Placebo
n=22 participants at risk
Participants will be given one dose of an identical looking sublingual placebo before performing a 10 minute speech task. Participants will then be assessed immediately after finishing the speech task.
Placebo: a sublingual tablet identical to the active drug will be given before performing an anxiety provoking speech task. Participants will then be clinically assessed immediately after finishing the speech task.
|
|---|---|---|
|
General disorders
Temporary perioral numbing
|
59.1%
13/22 • Number of events 13 • Up to 1 hour.
|
0.00%
0/22 • Up to 1 hour.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place