PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge - 2

(Palisade-2 Trial)

Recruiting at 15 trial locations

Overseen By Payal Patel, PharmD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: VistaGen Therapeutics, Inc.

Must not be taking: Psychotropics, Anxiolytics

Disqualifiers: Bipolar, Schizophrenia, Alcohol use, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

324 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Michael Liebowitz

Principal Investigator

Medical Research Network

Are You a Good Fit for This Trial?

Inclusion Criteria

SAD is currently diagnosed by checking for symptoms in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, and confirming those symptoms with the MINI.

The clinician rated the individual's LSAS total score as ≥70 at Screening.

The Hamilton Depression Score was less than eighteen at the screening visit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 to 35 days

1 visit (in-person)

Treatment

Participants self-administer the nasal spray and participate in a 5-minute public speaking challenge

1 day

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including repeat safety and psychiatric assessments

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PH94B Nasal Spray
• Placebo Nasal Spray

How Is the Trial Designed?

Group I: Placebo Experimental Treatment 1 Intervention

Placebo intranasal spray (100 microliters to each nostril) one time

Group II: PH94B Experimental Treatment 1 Intervention

3.2 micrograms PH94B intranasal spray (100 microliters to each nostril) one time

Who Is Running the Clinical Trial?

VistaGen Therapeutics, Inc.

Lead Sponsor

Trials

12

Recruited

1,900+