Trial Outcomes & Findings for PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge (NCT NCT04754802)
NCT ID: NCT04754802
Last Updated: 2025-09-12
Results Overview
The SUDS is a patient self-rated scale that is scored in the range of 0 to 100 (operationalized for participants in this study as 0=totally relaxed or no anxiety and 100=highest distress or anxiety ever felt
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
224 participants
Primary outcome timeframe
Visit 2 (Baseline; Day 0) to Visit 3 (Day 7 ± 2 days)
Results posted on
2025-09-12
Participant Flow
Participant milestones
| Measure |
PH94B
PH94B Nasal Spray - single treatment with 3.2 micrograms PH94B
|
Placebo
Placebo Nasal Spray - single treatment with placebo
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
112
|
|
Overall Study
COMPLETED
|
110
|
110
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
PH94B
PH94B Nasal Spray - single treatment with 3.2 micrograms PH94B
|
Placebo
Placebo Nasal Spray - single treatment with placebo
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge
Baseline characteristics by cohort
| Measure |
PH94B
n=112 Participants
3.2 micrograms PH94B intranasal spray (100 microliters to each nostril) one time
PH94B Nasal Spray: Nasal spray delivered 20 minutes before the public speaking stressor
|
Placebo
n=112 Participants
Placebo intranasal spray (100 microliters to each nostril) one time
Placebo Nasal Spray: Nasal spray delivered 20 minutes before the public speaking stressor
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
112 Participants
n=93 Participants
|
112 Participants
n=4 Participants
|
224 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
34.9 years
STANDARD_DEVIATION 10.69 • n=93 Participants
|
35.6 years
STANDARD_DEVIATION 11.71 • n=4 Participants
|
35.3 years
STANDARD_DEVIATION 11.19 • n=27 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
150 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=93 Participants
|
71 Participants
n=4 Participants
|
134 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
112 participants
n=93 Participants
|
112 participants
n=4 Participants
|
224 participants
n=27 Participants
|
|
Subjective Units of Distress (SUDS) score
|
77.7 score on a scale
STANDARD_DEVIATION 11.67 • n=93 Participants
|
78.2 score on a scale
STANDARD_DEVIATION 12.42 • n=4 Participants
|
77.95 score on a scale
STANDARD_DEVIATION 12.05 • n=27 Participants
|
PRIMARY outcome
Timeframe: Visit 2 (Baseline; Day 0) to Visit 3 (Day 7 ± 2 days)The SUDS is a patient self-rated scale that is scored in the range of 0 to 100 (operationalized for participants in this study as 0=totally relaxed or no anxiety and 100=highest distress or anxiety ever felt
Outcome measures
| Measure |
PH94B
n=112 Participants
3.2 micrograms PH94B intranasal spray (100 microliters to each nostril) one time
PH94B Nasal Spray: Nasal spray delivered 20 minutes before the public speaking stressor
|
Placebo
n=112 Participants
Placebo intranasal spray (100 microliters to each nostril) one time
Placebo Nasal Spray: Nasal spray delivered 20 minutes before the public speaking stressor
|
|---|---|---|
|
Subjective Units of Distress Scale (SUDS) Score
Visit 2
|
77.7 score on a scale
Standard Deviation 11.67
|
78.2 score on a scale
Standard Deviation 12.42
|
|
Subjective Units of Distress Scale (SUDS) Score
Visit 3
|
62.3 score on a scale
Standard Deviation 19.40
|
61.3 score on a scale
Standard Deviation 19.56
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline; Day 0) to Visit 3 (Day 7 ± 2 days)Population: Although the population of analysis included n=112, one subject had no CGI-I value. No imputation was done for secondary endpoints, resulting in n=111 in the denominator.
The CGI-I scale is a clinician-rated scale to assess illness improvement. The CGI-I scale includes one item scored from 1 (Very much less anxious) to 7 (Very much more anxious) with 4 being no change. Subjects are considered CGI-I responders with scores of 1 (Very much less anxious) or 2 (Much less anxious
Outcome measures
| Measure |
PH94B
n=111 Participants
3.2 micrograms PH94B intranasal spray (100 microliters to each nostril) one time
PH94B Nasal Spray: Nasal spray delivered 20 minutes before the public speaking stressor
|
Placebo
n=112 Participants
Placebo intranasal spray (100 microliters to each nostril) one time
Placebo Nasal Spray: Nasal spray delivered 20 minutes before the public speaking stressor
|
|---|---|---|
|
Proportions (%) of CGI-I Responders in PH94B-treated and Placebo-treated Groups at the End of Visit 3 (Treatment)
|
34 Participants
|
36 Participants
|
Adverse Events
PH94B
Serious events: 0 serious events
Other events: 0 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
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place