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

Study acronym: PALISADE-4
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Recruiting → Active, Not Recruiting Enrollment target: estimated 236 to confirmed 238 · Primary completion date changed from estimate of Apr 2026 to Apr 21, 2026 · Site details revised at 26 of 26 sitesv13 Show 3 more changesShow less
    • Enrollment target: estimated 236 to confirmed 238
    • Primary completion date changed from estimate of Apr 2026 to Apr 21, 2026
    • Site details revised at 26 of 26 sites
  2. Site details revised at 3 of 26 sitesv12
  3. Study sites: 25 to 26v11
  4. Study sites: 21 to 25v10
  5. Completion date: Oct 2026 to Apr 2027 Site details revised at 1 of 21 sitesv9 Show 1 more changeShow less
    • Site details revised at 1 of 21 sites
Show 7 earlier versionsHide 7 earlier versions
  1. Re-verified, no change to tracked fieldsv8
  2. Study sites: 18 to 21 Primary completion date: Oct 2025 to Apr 2026v7 Show 1 more changeShow less
    • Primary completion date: Oct 2025 to Apr 2026
  3. Study sites: 17 to 18v6
  4. Site details revised at 1 of 17 sitesv5
  5. Study sites: 12 to 17v4
  6. Study Identification, Study Status, Oversight, Contacts/Locations, Referencesv3
  7. Study sites: 4 to 12v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06615557
Lead Sponsor VistaGen Therapeutics, Inc.
Conditions Social Anxiety Disorder (SAD)
Enrollment 238 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov