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PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge - 2 (Palisade-2 Trial)

Phase 3
Waitlist Available
Led By Michael Liebowitz
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 3 weeks
Treatment Varies
Follow Up 20 minutes
Awards & highlights
Pivotal Trial

Summary

This trial tests a nasal spray called PH94B to help adults with social anxiety disorder feel less anxious during public speaking. The spray is used shortly before speaking, and its effects are measured by asking participants about their anxiety levels. The goal is to see if the spray is safe and effective.

Eligible Conditions
  • Social Anxiety Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 minutes 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
Clinical Global Impression - Improvement

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
Group I: PlaceboExperimental Treatment1 Intervention
Placebo intranasal spray (100 microliters to each nostril) one time
Group II: PH94BExperimental Treatment1 Intervention
3.2 micrograms PH94B intranasal spray (100 microliters to each nostril) one time
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PH94B Nasal Spray
2021
Completed Phase 3
~210
Placebo Nasal Spray
2006
Completed Phase 3
~3780

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Who is running the clinical trial?

VistaGen Therapeutics, Inc.Lead Sponsor
10 Previous Clinical Trials
1,497 Total Patients Enrolled
Michael LiebowitzPrincipal InvestigatorMedical Research Network
1 Previous Clinical Trials
23 Total Patients Enrolled
~76 spots leftby Dec 2025
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