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ACTIVE NOT RECRUITING Phase 3

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

NCT06358651 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DRUG Fasedienol Nasal Spray
  • DRUG Placebo Nasal Spray

Study Locations (20)

Florida

  • Vistagen Clinical Site — Jacksonville
  • Vistagen Clinical Site — Lakeland
  • Vistagen Clinical Site — Orlando
  • Vistagen Clinical Site — West Palm Beach

California

  • Vistagen Clinical Site — Lafayette
  • Vistagen Clinical Site — Oceanside
  • Vistagen Clinical Site — Sherman Oaks

Arkansas

  • Vistagen Clinical Site — Fayetteville
  • Vistagen Clinical Site — Little Rock

Arizona

  • Vistagen Clinical Site — Phoenix

Colorado

  • Vistagen Clinical Site — Denver

Connecticut

  • Vistagen Clinical Site — Cromwell

Illinois

  • Vistagen Clinical Site — Chicago

Kansas

  • Vistagen Clinical Site — Overland Park

Trial Details

FieldValue
Enrollment Target 238 participants
Start Date 2024-03-28
Est. Completion 2026-10
Phase Phase 3

Sponsor

VistaGen Therapeutics

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06358651

The ClinicalTrials.gov registry entry for NCT06358651 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 238 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VistaGen Therapeutics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Social Anxiety Disorder appearing as the primary indexed condition, and to 2 interventions — of which Fasedienol Nasal Spray is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06358651 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Florida, California, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06358651 about?

NCT06358651 is a clinical study titled "Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3)". 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...

What is the current status of trial NCT06358651?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 238 participants. The study started on 2024-03-28. Estimated completion is 2026-10.

What conditions does trial NCT06358651 study?

This clinical trial studies the following conditions: Social Anxiety Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06358651?

The interventions under investigation include: Fasedienol Nasal Spray (DRUG), Placebo Nasal Spray (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06358651?

This trial is sponsored by VistaGen Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06358651 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial