Active — Not RecruitingPhase 3

Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3)

United States238 participantsStarted 2024-03-28

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 \<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…

What they're measuring

Subjective Units of Distress Scale (SUDS)

Timeframe: 7 days (Visit 2 to Visit 3)

Trial details

NCT IDNCT06358651

SponsorVistaGen Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-31