Trial · NCT04754802
PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge
NCT04754802, Phase 3, Completed, VistaGen Therapeutics, Inc.; results first posted 2025-09-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge. Trials, record NCT04754802. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04754802
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge
- NCT number
- NCT04754802
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 224 participants, actual
- Lead sponsor
- VistaGen Therapeutics, Inc.
- Conditions
- Social Anxiety Disorder
- Interventions
- PH94B Nasal Spray, Placebo Nasal Spray
- First posted
- 2021-02-15
- Last updated
- 2025-09-12
- Results first posted
- 2025-09-12
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Subjective Units of Distress Scale (SUDS) Score | 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 |
| Secondary | Proportions (%) of CGI-I Responders in PH94B-treated and Placebo-treated Groups at the End of Visit 3 (Treatment) | 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 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Subjective Units of Distress Scale (SUDS) Score | Visit 2 (Baseline; Day 0) to Visit 3 (Day 7 ± 2 days) | score on a scale | MEAN | |
| SECONDARY | Proportions (%) of CGI-I Responders in PH94B-treated and Placebo-treated Groups at the End of Visit 3 (Treatment) | Visit 2 (Baseline; Day 0) to Visit 3 (Day 7 ± 2 days) | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Subjective Units of Distress Scale (SUDS) Score | PH94B | Visit 2 | 77.7 | Standard Deviation 11.67 | score on a scale |
| Subjective Units of Distress Scale (SUDS) Score | Placebo | Visit 2 | 78.2 | Standard Deviation 12.42 | score on a scale |
| Subjective Units of Distress Scale (SUDS) Score | PH94B | Visit 3 | 62.3 | Standard Deviation 19.40 | score on a scale |
| Subjective Units of Distress Scale (SUDS) Score | Placebo | Visit 3 | 61.3 | Standard Deviation 19.56 | score on a scale |
| Proportions (%) of CGI-I Responders in PH94B-treated and Placebo-treated Groups at the End of Visit 3 (Treatment) | PH94B | 34 | Participants | ||
| Proportions (%) of CGI-I Responders in PH94B-treated and Placebo-treated Groups at the End of Visit 3 (Treatment) | Placebo | 36 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PH94B | 112 | |
| Overall Study | STARTED | Placebo | 112 | |
| Overall Study | COMPLETED | PH94B | 110 | |
| Overall Study | COMPLETED | Placebo | 110 | |
| Overall Study | NOT COMPLETED | PH94B | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PH94B | 0 | 111 |
| Total, all-cause mortality | Placebo | 0 | 112 |
| Total, other adverse events | PH94B | 0 | 111 |
| Total, other adverse events | Placebo | 0 | 112 |
| Total, serious adverse events | PH94B | 0 | 111 |
| Total, serious adverse events | Placebo | 0 | 112 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24700254 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PH94B vs Placebo: Proportions (%) of CGI-I Responders in PH94B-treated and Placebo-treated Groups at the End of Visit 3 (Treatment) | Trial comparisons |
| PH94B vs Placebo: deaths from any cause | Trial comparisons |
| PH94B vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04754802
GET https://conductscience.org/api/trials/v1/NCT04754802/registered