Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD)

A Phase 3 Open-label Safety Trial of PH94B Nasal Spray in the Acute Treatment of Anxiety in Adult Subjects With Social Anxiety Disorder (SAD)

This study evaluates the safety and tolerability of PH94B with repeated dosing over a period of up to 12 months. Participating subjects will use PH94B up to 4 times a day when they encounter anxiety-provoking situations in daily life. Safety and tolerability of PH94B (≤ 4 doses per day up to 12 months) will be assessed and summarized during monthly visits from baseline (Visit 2) to end of treatment (Visit 14) in AEs, laboratory values, 12-lead ECGs, physical examinations, and vital sign assessments following exposure to PH94B.

Study Overview

• Status: Terminated
• Conditions: Social Anxiety Disorder
• Intervention / Treatment: Drug: PH94B

• Study Type: Interventional
• Enrollment (Actual): 481
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Watertown, Massachusetts, United States, 02472
      • VistaGen Investigational Site
  • New York
    • New York, New York, United States, 10128
      • VistaGen Investigational Site
  • Washington
    • Bellevue, Washington, United States, 98007
      • VistaGen Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Most but not all patients will enter the study following completion of Palisade-1 (NCT047548020) and Palisade-2 (NCT05011396).

Inclusion Criteria:

1. Male and female adults, 18 through 65 years of age, inclusive.
2. 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) (for subjects who attend Visit 1) and Baseline (Visit 2), prior to IP administration. Effective methods of contraception include: condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), or implantable contraceptive devices.
3. Current diagnosis of social anxiety disorder
4. Clinician-rated HAM-D17 total score < 18 at study entry
5. LSAS score 50 or greater

Exclusion Criteria:

1. Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, psychosis, anorexia or bulimia, 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.
2. Subjects who meet criteria for moderate or severe alcohol or substance use disorder within the 1 year prior to study entry.
3. In the opinion of the Investigator, the subject has a significant risk for suicidal behavior during the course of their participation in the study.
4. 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.
5. 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.

6. Subjects using the following psychotropic medications: anticonvulsants, mood stabilizers, antipsychotic medications, gabapentin, pregabalin, opioids, naltrexone, esketamine, and ketamine at enrollment.

   Subjects using lower doses of atypical antipsychotics at Screening may be eligible after discussion with the Medical Monitor (e.g., quetiapine < 100 mg).

   In general, subjects using antidepressants or buspirone can continue to receive these provided that they have been taking them for a minimum of 2 months, and have been on a stable dose for a minimum of 1 month.

7. Use of 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.
8. 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.

9. Subjects with clinically significant abnormalities in hematology, blood chemistry, urinalysis, 12-lead ECG, or physical examination identified at the Screening visit or Baseline visit that in the clinical judgment of the Investigator, could place the subject at undue risk, interfere with study participation, or confound the results of the study.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PH94B 3.2 micrograms; 100 microliter nasal spray to each nostril up to four times a day as needed for acute anxiety	Drug: PH94B; Nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Subjects with at least one Serious Adverse Event (SAE)	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Liebowitz Social Anxiety Scale (LSAS) Scores Over Time With Use of PH94B	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.	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)

Collaborators and Investigators

• Sponsor: VistaGen Therapeutics, Inc.
• Investigators: Study Director: Jaakko Lappalainen, MD, PhD, VistaGen Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): September 23, 2022
• Study Completion (Actual): September 23, 2022

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Estimated): October 21, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: PH94B-CL030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No