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

• ClinicalTrials.gov Identifier: NCT05011396
• Recruitment Status: Terminated
• First Posted: August 18, 2021
• Last Update Posted: July 13, 2023
• Sponsor: VistaGen Therapeutics, Inc.
• Information provided by (Responsible Party): VistaGen Therapeutics, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Social Anxiety Disorder	Drug: PH94B Nasal Spray; Drug: Placebo Nasal Spray	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 324 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: August 30, 2021
• Actual Primary Completion Date: August 16, 2022
• Actual Study Completion Date: August 16, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Subjective Units of Distress Scale (SUDS) [ Time Frame: 20 minutes ]
   0-100 self-report scale of level of anxiety

Secondary Outcome Measures :

1. Clinical Global Impression - Improvement [ Time Frame: 20 minutes ]
   Investigator-reported impression

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. Written informed consent provided prior to conducting any study-specific assessment.
2. Male and female adults, 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, and confirmed by the MINI.
4. Clinician-rated 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 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.
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, 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, or

   1. 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
   2. At Screening (Visit 1): the subject has had 1 or more suicidal attempts with reference to a 2 year period prior to screening; or
   3. 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
   4. The subject is considered to be an imminent danger to themself or others.
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. 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).
7. Use of any psychotropic medication within 30 days before study entry (other than medication permitted for insomnia: eszopiclone, ramelteon, melatonin, zaleplon, zolpidem, or antihistamines).
8. 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.
9. 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.
10. Prior participation in a clinical trial involving PH94B.
11. Women who have a positive 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.

Contacts and Locations

Locations

United States, Arizona

VistaGen Clinical Site

Phoenix, Arizona, United States, 85012

United States, California

VistaGen Clinical Site

Garden Grove, California, United States, 92845

VistaGen Clinical Site

Oceanside, California, United States, 92056

VistaGen Clinical Site

Temecula, California, United States, 92591

United States, Georgia

VistaGen Clinical Site

Alpharetta, Georgia, United States, 30022

United States, Kansas

VistaGen Clinical Site

Prairie Village, Kansas, United States, 66208

United States, Massachusetts

VistaGen Clinical Site

Boston, Massachusetts, United States, 02131

United States, Mississippi

VistaGen Clinical Site

Flowood, Mississippi, United States, 39232

United States, New Jersey

VistaGen Clinical Site

Berlin, New Jersey, United States, 08009

United States, New York

VistaGen Clinical Site

Brooklyn, New York, United States, 11235

VistaGen Clinical Site

New York, New York, United States, 10032

VistaGen Clinical Site

Rochester, New York, United States, 14618

United States, Pennsylvania

VistaGen Clinical Center

Allentown, Pennsylvania, United States, 18104

United States, Tennessee

VistaGen Clinical Site

Memphis, Tennessee, United States, 38119

United States, Texas

VistaGen Clinical Site

Austin, Texas, United States, 78737

Sponsors and Collaborators

VistaGen Therapeutics, Inc.

Investigators

• Principal Investigator: Michael Liebowitz; Medical Research Network

More Information

• Responsible Party: VistaGen Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT05011396
• Other Study ID Numbers: PH94B-CL032
• First Posted: August 18, 2021
• Last Update Posted: July 13, 2023
• Last Verified: July 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Anxiety Disorders; Phobia, Social; Mental Disorders; Phobic Disorders