Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)
Public ClinicalTrials.gov record NCT06615557. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
US, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Fasedienol Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects With Social Anxiety Disorder, With an Open-Label Extension (PALISADE-4)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06615557
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 238 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 15, 2024
- Primary completion
- Apr 20, 2026
- Completion
- Mar 31, 2027
- Last update posted
- May 21, 2026
2024 – 2027
United States locations
- U.S. sites
- 26
- U.S. states
- 16
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Vistagen Clinical Site | Phoenix | Arizona | 85012 | — |
| Vistagen Clinical Site | Little Rock | Arkansas | 72211 | — |
| Vistagen Clinical Site | Bellflower | California | 90706 | — |
| Vistagen Clinical Site | Oceanside | California | 92056 | — |
| Vistagen Clinical Site | Orange | California | 92868 | — |
| Vistagen Clinical Site | Redlands | California | 92374 | — |
| Vistagen Clinical Site | Torrance | California | 90504 | — |
| Vistagen Clinical Site | Denver | Colorado | 80209 | — |
| Vistagen Clinical Site | Tampa | Florida | 33629 | — |
| Vistagen Clinical Site | Decatur | Georgia | 30030 | — |
| Vistagen Clinical Site | Chicago | Illinois | 60640 | — |
| Vistagen Clinical Site | Naperville | Illinois | 60563 | — |
| Vistagen Clinical Site | Boston | Massachusetts | 02131 | — |
| Vistagen Clinical Site | Bloomfield Township | Michigan | 48302 | — |
| Vistagen Clinical Site | Flowood | Mississippi | 39232 | — |
| Vistagen Clinical Site | Las Vegas | Nevada | 89119 | — |
| Vistagen Clinical Site | Las Vegas | Nevada | 89121 | — |
| Vistagen Clinical Site | Albuquerque | New Mexico | 87109 | — |
| Vistagen Clinical Site | New York | New York | 10128 | — |
| Vistagen Clinical Site | Cincinnati | Ohio | 45229 | — |
| Vistagen Clinical Site | Austin | Texas | 78737 | — |
| Vistagen Clinical Site | Austin | Texas | 78759 | — |
| Vistagen Clinical Site | Dallas | Texas | 75251 | — |
| Vistagen Clinical Site | Houston | Texas | 77055 | — |
| Vistagen Clinical Site | San Antonio | Texas | 78229 | — |
| Vistagen Clinical Site | Everett | Washington | 98201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06615557, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 21, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06615557 live on ClinicalTrials.gov.