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

Purpose

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.

Condition

Social Anxiety Disorder (SAD)

Eligibility

Eligible Ages: Between 18 Years and 65 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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 <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.

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Fasedienol Nasal Spray		Drug: Fasedienol Nasal Spray Nasal spray delivered 20 minutes before the PSC
Experimental Placebo Nasal Spray		Drug: Placebo Nasal Spray Nasal spray delivered 20 minutes before the PSC

Recruiting Locations

Vistagen Clinical Site
Phoenix 5308655, Arizona 5551752 85012

Vistagen Clinical Site
Bellflower 5327422, California 5332921 90706

Vistagen Clinical Site
Oceanside 5378771, California 5332921 92056

Vistagen Clinical Site
Orange 5379513, California 5332921 92868

Vistagen Clinical Site
Redlands 5386754, California 5332921 92374

Vistagen Clinical Site
Torrance 5403022, California 5332921 90504

Vistagen Clinical Site
Denver 5419384, Colorado 5417618 80209

Vistagen Clinical Site
Tampa 4174757, Florida 4155751 33629

Vistagen Clinical Site
Naperville 4903279, Illinois 4896861 60563

Vistagen Clinical Site
Boston 4930956, Massachusetts 6254926 02131

Vistagen Clinical Site
Flowood 4426822, Mississippi 4436296 39232

Vistagen Clinical Site
Las Vegas 5506956, Nevada 5509151 89119

Vistagen Clinical Site
Albuquerque 5454711, New Mexico 5481136 87109

Vistagen Clinical Site
New York 5128581, New York 5128638 10128

Vistagen Clinical Site
Austin 4671654, Texas 4736286 78737

Vistagen Clinical Site
Austin 4671654, Texas 4736286 78759

Vistagen Clinical Site
Dallas 4684888, Texas 4736286 75251

Vistagen Clinical Site
Houston 4699066, Texas 4736286 77055

Vistagen Clinical Site
San Antonio 4726206, Texas 4736286 78229

Vistagen Clinical Site
Everett 5793933, Washington 5815135 98201

More Details

NCT ID: NCT06615557
Status: Recruiting
Sponsor: VistaGen Therapeutics, Inc.

Study Contact

Clinical Studies Vistagen Therapeutics, Inc.
650-577-3693
clinicalstudies@vistagen.com