Trial Outcomes & Findings for PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge - 2 (NCT NCT05011396)
NCT ID: NCT05011396
Last Updated: 2025-11-24
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
TERMINATED
PHASE3
228 participants
Visit 2 (Baseline; Day 0) to Visit 3 (Day 7 ± 2 days)
2025-11-24
Participant Flow
228 subjects were treated with placebo at V2. Of these 228 subjects, 87 were not randomized or administered double-blind study medication at V3, thus leaving 141 subjects in the ITT population at V3.
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
|
70
|
71
|
|
Overall Study
COMPLETED
|
67
|
68
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
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
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Positive Drug Screen
|
0
|
1
|
Baseline Characteristics
PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge - 2
Baseline characteristics by cohort
| Measure |
PH94B
n=70 Participants
PH94B Nasal Spray - single treatment with 3.2 micrograms PH94B
|
Placebo
n=71 Participants
Placebo Nasal Spray - single treatment with placebo
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=45 Participants
|
71 Participants
n=12929 Participants
|
141 Participants
n=6349 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Age, Continuous
|
35.3 years
STANDARD_DEVIATION 12.44 • n=45 Participants
|
32.6 years
STANDARD_DEVIATION 13.49 • n=12929 Participants
|
34.0 years
STANDARD_DEVIATION 13.01 • n=6349 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=45 Participants
|
51 Participants
n=12929 Participants
|
94 Participants
n=6349 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=45 Participants
|
20 Participants
n=12929 Participants
|
47 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
2 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=45 Participants
|
7 Participants
n=12929 Participants
|
10 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
2 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=45 Participants
|
12 Participants
n=12929 Participants
|
27 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=45 Participants
|
48 Participants
n=12929 Participants
|
98 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=45 Participants
|
71 participants
n=12929 Participants
|
141 participants
n=6349 Participants
|
|
Subjective Units of Distress Score (SUDS)
|
78.6 score on a scale
STANDARD_DEVIATION 12.11 • n=45 Participants
|
82.2 score on a scale
STANDARD_DEVIATION 11.58 • n=12929 Participants
|
80.41 score on a scale
STANDARD_DEVIATION 11.84 • n=6349 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=70 Participants
PH94B Nasal Spray - single treatment with 3.2 micrograms PH94B
|
Placebo
n=71 Participants
Placebo Nasal Spray - single treatment placebo
|
|---|---|---|
|
Subjective Units of Distress Scale (SUDS)
Visit 3
|
64.1 score on a scale
Standard Deviation 17.05
|
72.4 score on a scale
Standard Deviation 15.82
|
|
Subjective Units of Distress Scale (SUDS)
Visit 2
|
78.6 score on a scale
Standard Deviation 12.11
|
82.2 score on a scale
Standard Deviation 11.58
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline; Day 0) to Visit 3 (Day 7 ± 2 days)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=70 Participants
PH94B Nasal Spray - single treatment with 3.2 micrograms PH94B
|
Placebo
n=71 Participants
Placebo Nasal Spray - single treatment placebo
|
|---|---|---|
|
Proportions (%) of CGI-I Responders in PH94B-treated and Placebo-treated Groups at the End of Visit 3 (Treatment)
|
26 Participants
|
15 Participants
|
Adverse Events
Before V3 Dosing
PH94B
Placebo
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