PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge - 2

NCT05011396 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: PH94B-CL032
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Social Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• Subjective Units of Distress Scale (SUDS)

  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

  Visit 2 (Baseline; Day 0) to Visit 3 (Day 7 ± 2 days)

Secondary Outcomes (1)

• 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)

Study Arms (2)

PH94B

EXPERIMENTAL

3.2 micrograms PH94B intranasal spray (100 microliters to each nostril) one time

Drug: PH94B Nasal Spray

Placebo

EXPERIMENTAL

Placebo intranasal spray (100 microliters to each nostril) one time

Drug: Placebo Nasal Spray

Interventions

PH94B Nasal Spray DRUG

Nasal spray delivered 20 minutes before the public speaking stressor

PH94B

Placebo Nasal Spray DRUG

Nasal spray delivered 20 minutes before the public speaking stressor

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent provided prior to conducting any study-specific assessment.
• Male and female adults, 18 through 65 years of age, inclusive.
• Current diagnosis of SAD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, and confirmed by the MINI.
• Clinician-rated LSAS total score ≥70 at Screening (Visit 1).
• Clinician-rated Hamilton Depression Score 17-items total score \<18 at Screening (Visit 1).
• Women of childbearing-potential must be able to commit to the consistent and correct use of an effective method of birth control throughout the study, and must also have a negative urine pregnancy test result at both Screening (Visit 1) and Baseline (Visit 2), prior to investigational product (IP) administration. Effective methods of contraception include: condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), or implantable contraceptive devices.
• Negative COVID-19 test either in the presence of COVID-19 symptoms or after direct exposure to someone with a positive COVID-19 test

You may not qualify if:

• Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, psychosis, anorexia or bulimia, premenstrual dysphoric disorder, autism-spectrum disorder, or obsessive-compulsive disorder.
• Any other current Axis I disorder, other than SAD, which is the primary focus of treatment. Note that subjects with concurrent Generalized Anxiety Disorder are eligible for the study provided that Generalized Anxiety Disorder is not the primary diagnosis.
• Subjects who meet criteria for moderate or severe alcohol or substance use disorder within the 1 year prior to Study entry.
• In the opinion of the investigator, the subject has a significant risk for suicidal behavior during the course of their participation in the study, or
• At Screening (Visit 1): the subject scores "yes" on items 4 or 5 in the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C SSRS) with reference to a 6-month period prior to screening; or
• At Screening (Visit 1): the subject has had 1 or more suicidal attempts with reference to a 2 year period prior to screening; or
• At Baseline (Visit 2): the subject scores "yes" on items 4 or 5 in the Suicidal Ideation section of the C-SSRS with reference to screening; or
• The subject is considered to be an imminent danger to themself or others.
• Clinically significant nasal pathology or history of significant nasal trauma, nasal surgery, total anosmia, or nasal septum perforation that may have damaged the nasal chemosensory epithelium.
• An acute or chronic condition, including an infectious illness, uncontrolled seasonal allergies at the time of the study, or significant nasal congestion that potentially could affect drug delivery to the nasal chemosensory epithelium.
• Two or more documented failed treatment trials with a registered medication approved for SAD, at any time during the lifetime of the subject, whereby an adequate treatment trial is defined as that described in the package insert for a particular drug during which the subject received an adequate medication dosage (defined as the treatment dose indicated in the package insert to obtain efficacy for that particular drug).
• Use of any psychotropic medication within 30 days before study entry (other than medication permitted for insomnia: eszopiclone, ramelteon, melatonin, zaleplon, zolpidem, or antihistamines).
• Use of any anxiolytics, such as benzodiazepines or unapproved treatments such as beta blockers, within 30 days before study entry; concomitant use is prohibited during the study. Subjects who have been taking benzodiazepines daily for 1 month or longer at the time of Visit 1 are not eligible to participate.
• Use of any over-the-counter product, prescription product, or herbal preparation for treatment of the symptoms of anxiety or social anxiety within 30 days before study entry; concomitant use is prohibited during the study.
• Prior participation in a clinical trial involving PH94B.

Sponsors & Collaborators

• VistaGen Therapeutics, Inc.: lead

Study Sites (15)

VistaGen Clinical Site

Phoenix, Arizona, 85012, United States

Location

VistaGen Clinical Site

Garden Grove, California, 92845, United States

Location

VistaGen Clinical Site

Oceanside, California, 92056, United States

Location

VistaGen Clinical Site

Temecula, California, 92591, United States

Location

VistaGen Clinical Site

Alpharetta, Georgia, 30022, United States

Location

VistaGen Clinical Site

Prairie Village, Kansas, 66208, United States

Location

VistaGen Clinical Site

Boston, Massachusetts, 02131, United States

Location

VistaGen Clinical Site

Flowood, Mississippi, 39232, United States

Location

VistaGen Clinical Site

Berlin, New Jersey, 08009, United States

Location

VistaGen Clinical Site

Brooklyn, New York, 11235, United States

Location

VistaGen Clinical Site

New York, New York, 10032, United States

Location

VistaGen Clinical Site

Rochester, New York, 14618, United States

Location

VistaGen Clinical Center

Allentown, Pennsylvania, 18104, United States

Location

VistaGen Clinical Site

Memphis, Tennessee, 38119, United States

Location

VistaGen Clinical Site

Austin, Texas, 78737, United States

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Ester Salman, MPH
• Organization: Vistagen Therapeutics, Inc.

clinicalstudies@vistagen.com

650-577-3693

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 18, 2021
• Study Start: August 30, 2021
• Primary Completion: August 16, 2022
• Study Completion: August 16, 2022
• Last Updated: November 24, 2025
• Results First Posted: November 24, 2025

Record last verified: 2025-10

Locations

US (15)