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Completed Phase 3 Interventional Results available

PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge

ClinicalTrials.gov ID: NCT04754802

Public ClinicalTrials.gov record NCT04754802. 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.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 6:36 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of PH94B Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects With Social Anxiety Disorder

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
NCT04754802
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
VistaGen Therapeutics, Inc.
Industry
Enrollment
224 participants

Conditions and interventions

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
May 23, 2021
Primary completion
Jun 21, 2022
Completion
Jun 21, 2022
Last update posted
Sep 11, 2025

2021 – 2022

United States locations

U.S. sites
21
U.S. states
11
U.S. cities
21
Facility City State ZIP Site status
VistaGen Clinical Site Los Angeles California 90024
VistaGen Clinical Site Orange California 92868
VistaGen Clinical Site Riverside California 92503
VistaGen Clinical Site San Diego California 92103
VistaGen Clinical Site San Jose California 95124
VistaGen Clinical Site Sherman Oaks California 91403
VistaGen Clinical Sites Fort Myers Florida 33912
VistaGen Clinical Site Jacksonville Florida 32256
VistaGen Clinical Site Orlando Florida 32801
VistaGen Clinical Site Tampa Florida 33614
VistaGen Clinical Site Chicago Illinois 60640
VistaGen Clinical Site Watertown Massachusetts 02472
VistaGen Clinical Site Princeton New Jersey 08540
VistaGen Clinical Site New York New York 10128
VistaGen Clinical Site Oklahoma City Oklahoma 73106
VistaGen Clinical Site Allentown Pennsylvania 18104
VistaGen Clinical Site Media Pennsylvania 19063
VistaGen Clinical Site Houston Texas 77030
VistaGen Clinical Site San Antonio Texas 78229
VistaGen Clinical Site Woodstock Vermont 05091
VistaGen Clinical Site Bellevue Washington 98007

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 NCT04754802, 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 Sep 11, 2025 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04754802 live on ClinicalTrials.gov.

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