Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD)
Recruiting at 2 trial locations
CB
Overseen ByCherilyn Boller
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: VistaGen Therapeutics, Inc.
Must be taking: Antidepressants, Buspirone
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
This trial tests if PH94B is safe and tolerable for people with anxiety. Participants will use it multiple times daily when anxious, and their health will be regularly monitored.
Research Team
JL
Jaakko Lappalainen, MD, PhD
Principal Investigator
VistaGen Therapeutics
Eligibility Criteria
Inclusion Criteria
Subjects who finish Palisade-1 (NCT047548020) and Palisade-2 (NCT05011396) will be in the study.
Women who might become pregnant during the study must be able to use contraception correctly and must have a negative pregnancy test before starting the study
is based on subjective judgement
Social anxiety disorder is currently being diagnosed based on the judgement of a person's subjective experiences.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants use PH94B nasal spray up to 4 times a day for anxiety-provoking situations over 12 months
12 months
Monthly visits from baseline to end of treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- PH94B
Participant Groups
1Treatment groups
Experimental Treatment
Group I: PH94B 3.2 microgramsExperimental Treatment1 Intervention
100 microliter nasal spray to each nostril up to four times a day as needed for acute anxiety
Find a Clinic Near You
Who Is Running the Clinical Trial?
VistaGen Therapeutics, Inc.
Lead Sponsor
Trials
12
Recruited
1,900+
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