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NCT06615557 · ClinicalTrials.gov registry record · Phase 3
Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)
A Phase 3 study of Social Anxiety Disorder (SAD), sponsored by VistaGen Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 236
- Enrollment target
- 20
- Study locations
NCT06615557: Recruiting Phase 3 study of Social Anxiety Disorder (SAD), sponsored by VistaGen Therapeutics.
NCT06615557 is a Phase 3 study of Social Anxiety Disorder (SAD) that is actively recruiting participants, run by VistaGen Therapeutics. The registered enrollment target is 236 participants, above the 155-participant average among 5 other Social Anxiety Disorder (SAD) trials with a reported enrollment target (52% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06615557, a Phase 3 study of Social Anxiety Disorder (SAD), is actively recruiting participants, sponsored by VistaGen Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 236 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-4 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)
California
- Vistagen Clinical Site - Bellflower
- Vistagen Clinical Site - Oceanside
- Vistagen Clinical Site - Orange
- Vistagen Clinical Site - Redlands
- Vistagen Clinical Site - Torrance
Illinois
- Vistagen Clinical Site - Chicago
- Vistagen Clinical Site - Naperville
Nevada
- Vistagen Clinical Site - Las Vegas
- Vistagen Clinical Site - Las Vegas
Arizona
- Vistagen Clinical Site - Phoenix
Arkansas
- Vistagen Clinical Site - Little Rock
Colorado
- Vistagen Clinical Site - Denver
Florida
- Vistagen Clinical Site - Tampa
Georgia
- Vistagen Clinical Site - Decatur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2024-09-16 |
| Est. Completion | 2027-04 |
| Phase | Phase 3 |
What NCT06615557 shows while recruiting
NCT06615557 is an interventional study that assigns participants to a tested intervention. The registered 236 participants enrollment target is mid-sized for trials with a published cap, above the 155-participant average among 5 other Social Anxiety Disorder (SAD) trials with a reported enrollment target (52% higher).
The record links to 1 condition, with Social Anxiety Disorder (SAD) appearing as the primary indexed condition, and to 2 interventions - of which Fasedienol Nasal Spray is the first listed.
NCT06615557 names 20 study sites across 14 states, led by California, Illinois, Nevada.
Frequently Asked Questions
What is clinical trial NCT06615557 about?
NCT06615557 is a clinical study titled "Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)". 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 NCT06615557?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 236 participants. The study started on 2024-09-16. Estimated completion is 2027-04.
What conditions does trial NCT06615557 study?
This clinical trial studies the following conditions: Social Anxiety Disorder (SAD).
What interventions are being tested in trial NCT06615557?
The interventions under investigation include: Fasedienol Nasal Spray (DRUG), Placebo Nasal Spray (DRUG).
Who is sponsoring clinical trial NCT06615557?
This trial is sponsored by VistaGen Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06615557 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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