Fasedienol Nasal Spray for Social Anxiety Disorder (PALISADE-4 Trial)

Verified 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

Must not have

Do you smoke more than 10 cigarettes per day or user electronic cigarettes (e.g., "vaping") on a daily basis?

In the past year, have you used alcohol or drugs multiple times per day?

Timeline

Screening 1 week

Treatment 1 week

Follow Up 1 week

Awards & highlights

Pivotal Trial

Summary

This Phase 3 clinical trial is designed to evaluate the Fasedienol Nasal Spray (fasedienol) for adults that are 18-65 who suffer from symptoms of social anxiety such as nervousness, worry or fear of judgement. In addition, there is an Open Label Extension phase of the study for patients that choose to participate where use of nasal spray for up to 12 months will be assessed.

Who is the study for?

Adults aged 18-65 with symptoms of Social Anxiety. 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 Social Anxiety.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 1 week1 visit

Treatment ~ 1 week2 visits

Follow Up ~ 1 week1 visit

Screening ~ 1 week

Treatment ~ 1 week

Follow Up ~1 week

This trial's timeline: 1 week for screening, 2 visits that are 1 week apart for treatment, and 1 week for reporting. There is also an open label period where patients will have the opportunity to use Fasedienol in everyday life prior to stressful situations or events up to 12 months.