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PH94B Nasal Spray for Social Anxiety Disorder (Palisade-1 Trial)
Phase 3
Waitlist Available
Led By Michael Liebowitz, MD
Research Sponsored by VistaGen Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female adult, 18 through 65 years of age, inclusive.
Clinician-rated Liebowitz Social Anxiety Scale (LSAS) total score ≥70 at Screening (Visit 1).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 minutes
Awards & highlights
Palisade-1 Trial Summary
PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge
Eligible Conditions
- Social Anxiety Disorder
Palisade-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
An adult aged 18 through 65 years, who is male or female.
Select...
The patient had a Liebowitz Social Anxiety Scale (LSAS) total score ≥70 at Screening (Visit 1).
Select...
The Hamilton Depression Score is 17-items total score less than 18 at Screening (Visit 1).
Palisade-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Subjective Units of Distress Scale (SUDS)
Secondary outcome measures
Clinical Global Impression - Improvement
Palisade-1 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
Placebo Nasal Spray
2006
Completed Phase 3
~3780
PH94B Nasal Spray
2021
Completed Phase 3
~210
Find a Location
Who is running the clinical trial?
VistaGen Therapeutics, Inc.Lead Sponsor
8 Previous Clinical Trials
1,140 Total Patients Enrolled
Michael Liebowitz, MDPrincipal InvestigatorMedical Research Network
2 Previous Clinical Trials
286 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
California
Other
Pennsylvania
New Jersey
How old are they?
18 - 65
What site did they apply to?
VistaGen Clinical Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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