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

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

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 236 to confirmed 238 · Primary completion date changed from estimate of Oct 2025 to Oct 31, 2025 · Site details revised at 24 of 24 sitesv11 Show 3 more changesShow less
    • Enrollment target: estimated 236 to confirmed 238
    • Primary completion date changed from estimate of Oct 2025 to Oct 31, 2025
    • Site details revised at 24 of 24 sites
  2. Completion date: Jun 2026 to Oct 2026 Site details revised at 7 of 24 sitesv10 Show 1 more changeShow less
    • Site details revised at 7 of 24 sites
  3. Primary completion date: Jun 2025 to Oct 2025 Site details revised at 1 of 24 sitesv9 Show 1 more changeShow less
    • Site details revised at 1 of 24 sites
  4. Study sites: 19 to 24v8
  5. Study sites: 16 to 19v7
Show 5 earlier versionsHide 5 earlier versions
  1. Site details revised at 1 of 16 sitesv6
  2. Study sites: 14 to 16v5
  3. Study sites: 10 to 14v4
  4. Re-verified, no change to tracked fieldsv3
  5. Study sites: 5 to 10v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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-3 and choose to enter the distinct open-label extension phase of the study.
Trial Details
NCT Number NCT06358651
Lead Sponsor VistaGen Therapeutics, Inc.
Conditions Social Anxiety Disorder
Enrollment 238 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov