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NCT06809179 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial to Assess the Efficacy, Safety, and Tolerability of a Repeat Dose of Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder
A Phase 2 study of Social Anxiety Disorder, sponsored by VistaGen Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 9
- Study locations
NCT06809179 is a Phase 2 study of Social Anxiety Disorder that is actively recruiting participants, run by VistaGen Therapeutics. The registered enrollment target is 60 participants, below the 158-participant average among 32 other Social Anxiety Disorder trials with a reported enrollment target (62% lower). The trial reports 9 study locations across 8 states.
The verdict
NCT06809179, a Phase 2 study of Social Anxiety Disorder, is actively recruiting participants, sponsored by VistaGen Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 9
- Study locations
Study Summary
This U.S. multicenter, double-blind, placebo-controlled Phase 2 clinical trial is designed to evaluate the efficacy, safety, and tolerability of a repeat intranasal (i.n.) dose 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 PH94B-CL036 and choose to enter the distinct open-label extension phase of the study.
Conditions Studied
Interventions
- DRUG Fasedienol Nasal Spray - Placebo Nasal Spray
- DRUG Fasedienol Nasal Spray - Fasedienol Nasal Spray
- DRUG Placebo Nasal Spray - Placebo Nasal Spray
Study Locations (9)
California
- Vistagen Clinical Site - Sherman Oaks
- Vistagen Clinical Site - Walnut Creek
Florida
- Vistagen Clinical Site - Largo
Missouri
- Vistagen Clinical Site - Saint Charles
New Jersey
- Vistagen Clinical Site - Toms River
North Carolina
- Vistagen Clinical Site - Cary
Ohio
- Vistagen Clinical Site - Cleveland
Pennsylvania
- Vistagen Clinical Site - Plymouth Meeting
Texas
- Vistagen Clinical Site - Plano
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-01-09 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06809179
The ClinicalTrials.gov registry entry for NCT06809179 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 158-participant average among 32 other Social Anxiety Disorder trials with a reported enrollment target (62% lower). The listed sponsor is VistaGen Therapeutics, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Social Anxiety Disorder appearing as the primary indexed condition, and to 3 interventions - of which Fasedienol Nasal Spray - Placebo Nasal Spray is the first listed.
NCT06809179 reports 9 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT06809179 about?
NCT06809179 is a clinical study titled "A Clinical Trial to Assess the Efficacy, Safety, and Tolerability of a Repeat Dose of Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder". This U.S. multicenter, double-blind, placebo-controlled Phase 2 clinical trial is designed to evaluate the efficacy, safety, and tolerability of a repeat intranasal (i.n.) dose of Fasedienol Nasal Spray (fasedienol) (3.2 µg) to relieve symptoms of acute anxiety in adult subjects ages 18 through 65 w...
What is the current status of trial NCT06809179?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-01-09. Estimated completion is 2026-12.
What conditions does trial NCT06809179 study?
This clinical trial studies the following conditions: Social Anxiety Disorder.
What interventions are being tested in trial NCT06809179?
The interventions under investigation include: Fasedienol Nasal Spray - Placebo Nasal Spray (DRUG), Fasedienol Nasal Spray - Fasedienol Nasal Spray (DRUG), Placebo Nasal Spray - Placebo Nasal Spray (DRUG).
Who is sponsoring clinical trial NCT06809179?
This trial is sponsored by VistaGen Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06809179 being conducted?
This trial has 9 study locations across California, Florida, Missouri, New Jersey, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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