NCT05011396

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

A US, Phase 3 Multicenter, Randomized, Double-blind, Placebo Controlled Trial of PH94B Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects With Social Anxiety Disorder (PaliSADe-2)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: VistaGen Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute administration of 3.2 µg of PH94B to relieve symptoms of anxiety in adult subjects with social anxiety disorder (SAD) during an induced public speaking challenge. Subject participation in the Study will last a total of 3 to 7 weeks, depending on the duration of the screening period and intervals between visits. Upon signing an informed consent, all subjects will complete Visit 1 (Screening) and enter a screening period lasting between 3 and 35 days. If subjects meet all eligibility criteria at the end of the screening period, subjects will return for Visit 2 and self-administer the nasal spray and then participate in a 5 minute public speaking challenge. During the public speaking challenge, the subject will be asked for their anxiety score, which will be recorded by a trained observer. At Visit 3, the subjects will undergo the same public speaking procedure once again as they did in Visit 2. One week after the completion of the Visit 3 public speaking challenge, the subject will come back for Visit 4 (Follow-up) that will involve a repeat of the safety and psychiatric assessments conducted at Screening.

Conditions

• Social Anxiety Disorder

Interventions

Type	Name	Description
DRUG	PH94B Nasal Spray	Nasal spray delivered 20 minutes before the public speaking stressor
DRUG	Placebo Nasal Spray	Nasal spray delivered 20 minutes before the public speaking stressor

Timeline

• Start date: 2021-08-30
• Primary completion: 2022-08-16
• Completion: 2022-08-16
• First posted: 2021-08-18
• Last updated: 2025-11-24
• Results posted: 2025-11-24

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study