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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: Recruiting Phase 2 study of Social Anxiety Disorder, sponsored by VistaGen Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The SUDS is a patient self-rated acute measurement scale that is scored in the range of 0 to 100 (operationalized for participants in this study as 0=totally relaxed or no anxiety at all and 100=highest distress or anxiety ever felt.
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 |
What NCT06809179 shows while recruiting
NCT06809179 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 158-participant average among 32 other Social Anxiety Disorder trials with a reported enrollment target (62% lower).
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 lists 9 locations in 8 states (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.
Learn More About Clinical Trials
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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 NCT06809179's enrollment target sits among peer trials
60 21st of 32 higher than 8 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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