PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge - 2
Public ClinicalTrials.gov record NCT05011396. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A US, Phase 3 Multicenter, Randomized, Double-blind, Placebo Controlled Trial of PH94B Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects With Social Anxiety Disorder (PaliSADe-2)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute administration of 3.2 µg of PH94B to relieve symptoms of anxiety in adult subjects with social anxiety disorder (SAD) during an induced public speaking challenge. Subject participation in the Study will last a total of 3 to 7 weeks, depending on the duration of the screening period and intervals between visits. Upon signing an informed consent, all subjects will complete Visit 1 (Screening) and enter a screening period lasting between 3 and 35 days. If subjects meet all eligibility criteria at the end of the screening period, subjects will return for Visit 2 and self-administer the nasal spray and then participate in a 5 minute public speaking challenge. During the public speaking challenge, the subject will be asked for their anxiety score, which will be recorded by a trained observer. At Visit 3, the subjects will undergo the same public speaking procedure once again as they did in Visit 2. One week after the completion of the Visit 3 public speaking challenge, the subject will come back for Visit 4 (Follow-up) that will involve a repeat of the safety and psychiatric assessments conducted at Screening.
Study identification
- NCT ID
- NCT05011396
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 228 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 29, 2021
- Primary completion
- Aug 15, 2022
- Completion
- Aug 15, 2022
- Last update posted
- Nov 23, 2025
2021 – 2022
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| VistaGen Clinical Site | Phoenix | Arizona | 85012 | — |
| VistaGen Clinical Site | Garden Grove | California | 92845 | — |
| VistaGen Clinical Site | Oceanside | California | 92056 | — |
| VistaGen Clinical Site | Temecula | California | 92591 | — |
| VistaGen Clinical Site | Alpharetta | Georgia | 30022 | — |
| VistaGen Clinical Site | Prairie Village | Kansas | 66208 | — |
| VistaGen Clinical Site | Boston | Massachusetts | 02131 | — |
| VistaGen Clinical Site | Flowood | Mississippi | 39232 | — |
| VistaGen Clinical Site | Berlin | New Jersey | 08009 | — |
| VistaGen Clinical Site | Brooklyn | New York | 11235 | — |
| VistaGen Clinical Site | New York | New York | 10032 | — |
| VistaGen Clinical Site | Rochester | New York | 14618 | — |
| VistaGen Clinical Center | Allentown | Pennsylvania | 18104 | — |
| VistaGen Clinical Site | Memphis | Tennessee | 38119 | — |
| VistaGen Clinical Site | Austin | Texas | 78737 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05011396, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 23, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05011396 live on ClinicalTrials.gov.