US, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Fasedienol Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects With Social Anxiety Disorder, With an Open-Label Extension (PALISADE-3)

VistaGen Therapeutics, Inc.1 site in 1 country238 target enrollmentMarch 28, 2024

ConditionsSocial Anxiety Disorder

InterventionsFasedienol Nasal Spray Placebo Nasal Spray

Overview

Phase: Phase 3
Intervention: Fasedienol Nasal Spray
Conditions: Social Anxiety Disorder
Sponsor: VistaGen Therapeutics, Inc.
Enrollment: 238
Locations: 1
Primary Endpoint: Subjective Units of Distress Scale (SUDS)
Status: Active, not recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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-3 and choose to enter the distinct open-label extension phase of the study.

Registry

clinicaltrials.gov

Start Date

March 28, 2024

End Date

October 1, 2026

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

VistaGen Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 (DSM-5), and confirmed by the Mini-International Neuropsychiatric Interview (MINI).
•Clinician-rated Liebowitz Social Anxiety Scale (LSAS) total score ≥70 at Screening (Visit 1).
•Clinician-rated Hamilton Depression Rating Scale (HAM-D) (17-items) total score \<
•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

Exclusion Criteria

•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
•Prior participation in a clinical trial involving fasedienol.

Arms & Interventions

Fasedienol Nasal Spray

Intervention: Fasedienol Nasal Spray

Placebo Nasal Spray

Intervention: Placebo Nasal Spray

Outcomes

Primary Outcomes

Subjective Units of Distress Scale (SUDS)

Time Frame: 7 days (Visit 2 to Visit 3)

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).