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NCT06358651 · ClinicalTrials.gov registry record · Phase 3
Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3)
A Phase 3 study of Social Anxiety Disorder, sponsored by VistaGen Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 238
- Enrollment target
- 20
- Study locations
NCT06358651: Active Phase 3 study of Social Anxiety Disorder, sponsored by VistaGen Therapeutics.
NCT06358651 is a Phase 3 study of Social Anxiety Disorder that is active but no longer recruiting, run by VistaGen Therapeutics. The registered enrollment target is 238 participants, above the 153-participant average among 32 other Social Anxiety Disorder trials with a reported enrollment target (56% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06358651, a Phase 3 study of Social Anxiety Disorder, is active but no longer recruiting, sponsored by VistaGen Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 238 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The SUDS is a patient self-rated scale that is scored in the range of 0 to 100 (operationalized for participants in this study as 0=totally relaxed or no anxiety and 100=highest distress or anxiety ever felt).
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
| Field | Value |
|---|---|
| Enrollment Target | 238 participants |
| Start Date | 2024-03-28 |
| Est. Completion | 2026-10 |
| Phase | Phase 3 |
What the registry record for NCT06358651 still lists
NCT06358651 is an interventional study that assigns participants to a tested intervention. The registered 238 participants enrollment target is mid-sized for trials with a published cap, above the 153-participant average among 32 other Social Anxiety Disorder trials with a reported enrollment target (56% higher).
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.
NCT06358651 names 20 study sites across 14 states, led by Florida, California, Arkansas.
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.
What interventions are being tested in trial NCT06358651?
The interventions under investigation include: Fasedienol Nasal Spray (DRUG), Placebo Nasal Spray (DRUG).
Who is sponsoring clinical trial NCT06358651?
This trial is sponsored by VistaGen Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Social Anxiety Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06358651's enrollment target sits among peer trials
238 9th of 32 higher than 24 of 32 other Social Anxiety Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Social Anxiety Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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