PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge (Palisade-1)

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

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 Overview

• Status: Completed
• Conditions: Social Anxiety Disorder
• Intervention / Treatment: Drug: PH94B Nasal Spray; Drug: Placebo Nasal Spray

• Study Type: Interventional
• Enrollment (Actual): 209
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90024
      • Vistagen Clinical Site
    • Orange, California, United States, 92868
      • Vistagen Clinical Site
    • Riverside, California, United States, 92503
      • Vistagen Clinical Site
    • San Diego, California, United States, 92103
      • Vistagen Clinical Site
    • San Jose, California, United States, 95124
      • Vistagen Clinical Site
    • Sherman Oaks, California, United States, 91403
      • Vistagen Clinical Site
  • Florida
    • Fort Myers, Florida, United States, 33912
      • VistaGen Clinical Sites
    • Jacksonville, Florida, United States, 32256
      • Vistagen Clinical Site
    • Orlando, Florida, United States, 32801
      • Vistagen Clinical Site
    • Tampa, Florida, United States, 33614
      • Vistagen Clinical Site
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Vistagen Clinical Site
  • Massachusetts
    • Watertown, Massachusetts, United States, 02472
      • Vistagen Clinical Site
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Vistagen Clinical Site
  • New York
    • New York, New York, United States, 10128
      • Vistagen Clinical Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73106
      • Vistagen Clinical Site
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Vistagen Clinical Site
    • Media, Pennsylvania, United States, 19063
      • Vistagen Clinical Site
  • Texas
    • Houston, Texas, United States, 77030
      • Vistagen Clinical Site
    • San Antonio, Texas, United States, 78229
      • Vistagen Clinical Site
  • Vermont
    • Woodstock, Vermont, United States, 05091
      • Vistagen Clinical Site
  • Washington
    • Bellevue, Washington, United States, 98007
      • Vistagen Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Written informed consent provided prior to conducting any study-specific assessment.
2. Male or female adult, 18 through 65 years of age, inclusive.
3. Current diagnosis of SAD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, as confirmed by the Mini-International Neuropsychiatric Interview (MINI).
4. Clinician-rated Liebowitz Social Anxiety Scale (LSAS) total score ≥70 at Screening (Visit 1).
5. Clinician-rated Hamilton Depression Score 17-items total score <18 at Screening (Visit 1).
6. Women of child bearing-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 IP administration. Effective methods of contraception include: condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), or implantable contraceptive devices.
7. Negative COVID-19 test either in the presence of COVID-19 symptoms or after direct exposure to someone with a positive COVID-19 test.

Exclusion Criteria:

1. Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, psychosis, anorexia or bulimia, premenstrual dysphoric 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, or considered to be an imminent danger to themselves or others.
4. Clinically significant nasal pathology or history of significant nasal trauma, nasal surgery, 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. Two or more documented failed treatment trials with a registered medication approved for SAD, taken at any time during the lifetime of the patient, whereby an adequate treatment trial is defined as that documented 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).
7. Use of any psychotropic medication within 30 days before Study entry (other than allowed medication for insomnia.
8. Concomitant use of any anxiolytics, such as benzodiazepines or unapproved treatments such as beta blockers, during the Study and within 30 days before Study entry.
9. Concomitant use of any over-the-counter, prescription product, or herbal preparation for treatment of the symptoms of anxiety or social anxiety during the Study and within 30 days before Study entry.
10. Prior participation in a clinical trial involving PH94B.
11. Women who have a positive serum or urine pregnancy test prior to IP administration.
12. Subjects with clinically significant abnormalities in hematology, blood chemistry, urinalysis, electrocardiogram, 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.
13. Subjects with a positive urine drug screen at either the Screening visit or Baseline visit (not including tetrahydrocannabinol).
14. Any current clinically significant and/or uncontrolled medical condition, based on medical history or as evidenced in screening assessments, such as SARS-Cov-2, HIV, cancer, stroke, congestive heart failure, uncontrolled diabetes mellitus, or any other medical condition or disease 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.
15. History of cancer or malignant tumor not in remission for at least 2 years. Basal cell skin cancers are not exclusionary.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PH94B; 3.2 micrograms PH94B intranasal spray (100 microliters to each nostril) one time	Drug: PH94B Nasal Spray; Nasal spray delivered 20 minutes before the public speaking stressor
Experimental: Placebo; Placebo intranasal spray (100 microliters to each nostril) one time	Drug: Placebo Nasal Spray; Nasal spray delivered 20 minutes before the public speaking stressor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Units of Distress Scale (SUDS)	0-100 self-report scale of level of anxiety	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression - Improvement	Investigator-reported impression	20 minutes

Collaborators and Investigators

• Sponsor: VistaGen Therapeutics, Inc.
• Investigators: Principal Investigator: Michael Liebowitz, MD, Medical Research Network

Publications and helpful links

General Publications

• Liebowitz MR, Salman E, Nicolini H, Rosenthal N, Hanover R, Monti L. Effect of an acute intranasal aerosol dose of PH94B on social and performance anxiety in women with social anxiety disorder. Am J Psychiatry. 2014 Jun;171(6):675-82. doi: 10.1176/appi.ajp.2014.12101342.

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2021
• Primary Completion (Actual): June 22, 2022
• Study Completion (Actual): June 22, 2022

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: PH94B-CL026

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