Trial · NCT05030350
Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD)
NCT05030350, Phase 3, Terminated, VistaGen Therapeutics, Inc.; results first posted 2025-10-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD). Trials, record NCT05030350. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05030350
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD)
- NCT number
- NCT05030350
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 481 participants, actual
- Lead sponsor
- VistaGen Therapeutics, Inc.
- Conditions
- Social Anxiety Disorder
- Interventions
- PH94B
- First posted
- 2021-09-01
- Last updated
- 2025-10-21
- Results first posted
- 2025-10-21
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 12 months | Subjects with at least one Serious Adverse Event (SAE) |
| Other | Change in Total Liebowitz Social Anxiety Scale (LSAS) Scores Over Time With Use of PH94B | V 2 (Baseline), V 3 (Month 1), V 4 (Month 2), V 5 (Month3), V 6 (Month 4), V 7 (Month 5), V 8 (Month 6), V 9 (Month 7), V 10 (Month 8), V11 (Month 9) | The LSAS is a clinician-rated scale that has been shown to be sensitive to treatment-related change in social anxiety symptoms. The scale consists of 24 items. Each item is given 2 ratings: fear or anxiety on scale of 0 to 3 (with 0 = none and 3 = severe) and avoidance on a scale of 0 to 3 (with 0 = never and 3 = usually), with a total maximum overall score of 144. The sum of the 24 fear or anxiety items and the sum of the 24 avoidance items are combined for a total LSAS score. |
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 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Change in Total Liebowitz Social Anxiety Scale (LSAS) Scores Over Time With Use of PH94B | V 2 (Baseline), V 3 (Month 1), V 4 (Month 2), V 5 (Month3), V 6 (Month 4), V 7 (Month 5), V 8 (Month 6), V 9 (Month 7), V 10 (Month 8), V11 (Month 9) | The number analyzed differs from overall number analyze as PH94B-CL030 was terminated early by the sponsor | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | PH94B | Subjects with at least one TEAE | 273 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | PH94B | Subjects with at least 1 Mild TEAE | 186 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | PH94B | Subjects with at least 1 Moderate TEAE | 78 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | PH94B | Subjects with at least 1 Severe TEAE | 9 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | PH94B | Subjects with at least 1 TEAE leading to study discontinuation | 14 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | PH94B | Subjects with at least 1 SAE | 6 | Participants | |
| Change in Total Liebowitz Social Anxiety Scale (LSAS) Scores Over Time With Use of PH94B | PH94B | Visit 2 (Baseline) | 93.4 | Standard Deviation 18.79 | score on a scale |
| Change in Total Liebowitz Social Anxiety Scale (LSAS) Scores Over Time With Use of PH94B | PH94B | Visit 3 (Month 1) | 76.6 | Standard Deviation 24.63 | score on a scale |
| Change in Total Liebowitz Social Anxiety Scale (LSAS) Scores Over Time With Use of PH94B | PH94B | Visit 4 (Month 2) | 73.0 | Standard Deviation 25.09 | score on a scale |
| Change in Total Liebowitz Social Anxiety Scale (LSAS) Scores Over Time With Use of PH94B | PH94B | Visit 5 (Month 3) | 67.6 | Standard Deviation 25.58 | score on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PH94B 3.2 Micrograms | 481 | |
| Overall Study | COMPLETED | PH94B 3.2 Micrograms | 0 | |
| Overall Study | NOT COMPLETED | PH94B 3.2 Micrograms | 481 |
Source ClinicalTrials.gov
Adverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | PH94B | 82 | 481 | |
| other | COVID-19 | Infections and infestations | PH94B | 55 | 481 | |
| serious | Ruptured ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | PH94B | 1 | 481 | |
| serious | Suicide attempt | Psychiatric disorders | PH94B | 1 | 481 | |
| serious | Pelvic abscess | Infections and infestations | PH94B | 1 | 481 | |
| serious | Ankle fracture | Injury, poisoning and procedural complications | PH94B | 1 | 481 | |
| serious | Diverticulitis intestinal perforated | Infections and infestations | PH94B | 1 | 481 | |
| serious | Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | PH94B | 1 | 481 | |
| serious | Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | PH94B | 1 | 481 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PH94B | 1 | 481 |
| Total, other adverse events | PH94B | 137 | 481 |
| Total, serious adverse events | PH94B | 6 | 481 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT05030350
GET https://conductscience.org/api/trials/v1/NCT05030350/registered