Clinical trial NCT06615557: Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)
Official title: 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-4)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
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
Lead sponsor: VistaGen Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-26
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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, 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 \&lt;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

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 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).
* Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk.

Primary outcomes:
measure: Subjective Units of Distress Scale (SUDS)
timeFrame: 7 days (Visit 2 to Visit 3)
Secondary outcomes:
measure: Global Impression Scale of Improvement (CGI-I)
timeFrame: 7 days (Visit 2 to Visit 3)
measure: Patient Global Impression of Change (PGI-C)
timeFrame: 7 days (Visit 2 to Visit 3)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Vistagen Clinical Site
state: Arkansas
city: Bellflower
country: United States
facility: Vistagen Clinical Site
state: California
city: Redlands
country: United States
facility: Vistagen Clinical Site
state: California
city: Torrance
country: United States
facility: Vistagen Clinical Site
state: California
city: Denver
country: United States
facility: Vistagen Clinical Site
state: Colorado
city: Tampa
country: United States
facility: Vistagen Clinical Site
state: Florida
city: Decatur
country: United States
facility: Vistagen Clinical Site
state: Georgia
city: Chicago
country: United States
facility: Vistagen Clinical Site
state: Illinois
city: Naperville
country: United States
facility: Vistagen Clinical Site
state: Illinois
city: Bloomfield Township
country: United States
facility: Vistagen Clinical Site
state: Michigan
city: Las Vegas
country: United States
facility: Vistagen Clinical Site
state: Nevada
city: Las Vegas
country: United States
facility: Vistagen Clinical Site
state: Nevada
city: Albuquerque
country: United States
facility: Vistagen Clinical Site
state: New Mexico
city: Cincinnati
country: United States
facility: Vistagen Clinical Site
state: Ohio
city: Austin
country: United States
facility: Vistagen Clinical Site
state: Texas
city: Dallas
country: United States
facility: Vistagen Clinical Site
state: Texas
city: Houston
country: United States
facility: Vistagen Clinical Site
state: Texas
Study officials:
References: