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Fasedienol Nasal Spray for Social Anxiety Disorder (PALISADE-3 Trial)

Phase 3
Recruiting
Research Sponsored by VistaGen Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 35 days
Treatment 2 weeks
Follow Up 1 weeks
Awards & highlights
Pivotal Trial

Summary

This Phase 3 clinical trial is designed to evaluate the Fasedienol Nasal Spray (fasedienol) 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.

Who is the study for?
Adults aged 18-65 with Social Anxiety Disorder who experience anxiety during public speaking. Participants must be able to use a nasal spray as needed, up to six times daily.
What is being tested?
The trial is testing Fasedienol Nasal Spray against a placebo to see if it helps reduce acute anxiety symptoms in social situations like public speaking.
What are the potential side effects?
 You may have some unwanted side effects and symptoms as a result of study treatment with fasedienol nasal spray. Consistent administration of fasedienol inside your nose may increase the risk of local site reactions including: soreness inside your nose, runny nose, nasal irritation, nasal dryness and nosebleeds. Overall, these occurred in less than 2% of subjects who have used fasedienol nasal spray in previous clinical studies.

Timeline

Screening ~ 35 days
Treatment ~ 2 weeks
Follow Up ~1 weeks
This trial's timeline: 35 days for screening, 2 weeks for treatment, and 1 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Subjective Units of Distress Scale (SUDS)
Secondary study objectives
Global Impression Scale of Improvement (CGI-I)
Patient Global Impression of Change (PGI-C)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Fasedienol Nasal SprayExperimental Treatment1 Intervention
Group II: Placebo Nasal SprayPlacebo Group1 Intervention

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Who is running the clinical trial?

VistaGen Therapeutics, Inc.Lead Sponsor
10 Previous Clinical Trials
1,585 Total Patients Enrolled
~118 spots leftby Jun 2025
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