Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)

NCT06615557 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: PH94B-CL043
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 26

Brief Summary

This U.S. Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute intranasal (i.n.) administration of Fasedienol Nasal Spray (fasedienol) (3.2 µg) to relieve symptoms of acute anxiety in adult subjects ages 18 through 65 with Social Anxiety Disorder induced by a public speaking challenge (PSC) in a clinical setting. In addition, safety and tolerability of i.n. administration of 3.2 µg of fasedienol, as-needed, up to 6 times per day for up to 12 months, will be assessed in those subjects who complete PALISADE-4 and choose to enter the distinct open-label extension phase of the study.

Conditions

Social Anxiety Disorder (SAD)

Keywords

Fasedienol; PH94B; social anxiety disorder; social anxiety; SAD; pherine; pherine nasal spray; acute treatment; anxiolytic; mental health; anxiety; performance anxiety; anxiety nasal spray; anxiety treatment; public speaking anxiety; social phobia; phobic disorders; mental disorder; speech task

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).

  7 days (Visit 2 to Visit 3)

Secondary Outcomes (2)

• Global Impression Scale of Improvement (CGI-I)

  7 days (Visit 2 to Visit 3)

• Patient Global Impression of Change (PGI-C)

  7 days (Visit 2 to Visit 3)

Study Arms (2)

Fasedienol Nasal Spray

EXPERIMENTAL

Drug: Fasedienol Nasal Spray

Placebo Nasal Spray

EXPERIMENTAL

Drug: Placebo Nasal Spray

Interventions

Fasedienol Nasal Spray DRUG

Nasal spray delivered 20 minutes before the PSC

Fasedienol Nasal Spray

Placebo Nasal Spray DRUG

Nasal spray delivered 20 minutes before the PSC

Placebo Nasal Spray

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-International Neuropsychiatric Interview (MINI).
• Clinician-rated Liebowitz Social Anxiety Score (LSAS) total score ≥70 at Screening (Visit 1).
• Clinician-rated Hamilton Depression Rating Scale (HAM-D) (17-items) total score \<16.
• Female subjects of childbearing potential must be able to commit to the consistent and correct use of an effective method of birth control throughout the study
• Subjects must have normal olfactory function

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 principal or personality disorder (previously known as Axis I or Axis II disorders), except for specific phobias or generalized anxiety disorder, provided that these are not the primary diagnosis.
• Subjects who meet criteria for moderate or severe alcohol use disorder within the 1 year prior to study entry, or any use of illicit substances or tetrahydrocannabinol ("THC") within 2 months 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 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.
• Two or more documented failed adequate treatment trials with a registered medication approved for SAD.
• Currently receiving cognitive-behavioral therapy (CBT), exposure therapy, or acceptance and commitment therapy.
• Subjects taking psychotropic medications within 30 days before Visit 2.
• Use of any over-the-counter product, prescription product, off-label treatment, cannabidiol ("CBD"), or herbal preparation for treatment of the symptoms of anxiety or social anxiety within 30 days before Visit 2.
• Prior participation in a clinical trial involving fasedienol.
• Participation in any other clinical trial within the last 30 days or during the course of the current trial.
• Subjects with a positive urine drug screen.
• Women who have a positive urine pregnancy test.
• Women who are currently breastfeeding are not eligible unless they are willing to stop breastfeeding for the duration of the study.
• Subjects who have tested positive and/or have exhibited symptoms consistent with SARS-CoV-2 infection during the 4 weeks prior to Screening (Visit 1).

Sponsors & Collaborators

• VistaGen Therapeutics, Inc.: lead

Study Sites (26)

Vistagen Clinical Site

Phoenix, Arizona, 85012, United States

Location

Vistagen Clinical Site

Little Rock, Arkansas, 72211, United States

Location

Vistagen Clinical Site

Bellflower, California, 90706, United States

Location

Vistagen Clinical Site

Oceanside, California, 92056, United States

Location

Vistagen Clinical Site

Orange, California, 92868, United States

Location

Vistagen Clinical Site

Redlands, California, 92374, United States

Location

Vistagen Clinical Site

Torrance, California, 90504, United States

Location

Vistagen Clinical Site

Denver, Colorado, 80209, United States

Location

Vistagen Clinical Site

Tampa, Florida, 33629, United States

Location

Vistagen Clinical Site

Decatur, Georgia, 30030, United States

Location

Vistagen Clinical Site

Chicago, Illinois, 60640, United States

Location

Vistagen Clinical Site

Naperville, Illinois, 60563, United States

Location

Vistagen Clinical Site

Boston, Massachusetts, 02131, United States

Location

Vistagen Clinical Site

Bloomfield Township, Michigan, 48302, United States

Location

Vistagen Clinical Site

Flowood, Mississippi, 39232, United States

Location

Vistagen Clinical Site

Las Vegas, Nevada, 89119, United States

Location

Vistagen Clinical Site

Las Vegas, Nevada, 89121, United States

Location

Vistagen Clinical Site

Albuquerque, New Mexico, 87109, United States

Location

Vistagen Clinical Site

New York, New York, 10128, United States

Location

Vistagen Clinical Site

Cincinnati, Ohio, 45229, United States

Location

Vistagen Clinical Site

Austin, Texas, 78737, United States

Location

Vistagen Clinical Site

Austin, Texas, 78759, United States

Location

Vistagen Clinical Site

Dallas, Texas, 75251, United States

Location

Vistagen Clinical Site

Houston, Texas, 77055, United States

Location

Vistagen Clinical Site

San Antonio, Texas, 78229, United States

Location

Vistagen Clinical Site

Everett, Washington, 98201, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Phobia, Social; Psychological Well-Being; Anxiety Disorders; Phobic Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

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: September 24, 2024
• First Posted: September 26, 2024
• Study Start: September 16, 2024
• Primary Completion: April 21, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (26)