A Phase 2, Three-arm, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of a Repeat Dose of Fasedienol (PH94B) Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects With Social Anxiety Disorder, With an Open-Label Extension

NCT06809179 Phase 2 RECRUITING

This U.S. multicenter, double-blind, placebo-controlled Phase 2 clinical trial is designed to evaluate the efficacy, safety, and tolerability of a repeat intranasal (i.n.) dose of Fasedienol Nasal Spray (fasedienol) (3.2 µg) to relieve symptoms of acute anxiety in adult subjects ages 18 through 65 with Social Anxiety Disorder induced by a public speaking challenge (PSC) in a clinical setting. In addition, safety and tolerability of i.n. administration of 3.2 µg of fasedienol, as-needed, up to 6 times per day for up to 12 months, will be assessed in those subjects who complete PH94B-CL036 and choose to enter the distinct open-label extension phase of the study.

Details

Lead sponsor	VistaGen Therapeutics, Inc.
Phase	Phase 2
Status	RECRUITING
Enrolment	60
Start date	2025-01-09
Completion	2026-12

Conditions

• Social Anxiety Disorder

Interventions

• Fasedienol Nasal Spray - Placebo Nasal Spray
• Fasedienol Nasal Spray - Fasedienol Nasal Spray
• Placebo Nasal Spray - Placebo Nasal Spray

Primary outcomes

• Subjective Units of Distress Scale (SUDS) — 7 days (Visit 2 to Visit 3)
  The SUDS is a patient self-rated acute measurement scale that is scored in the range of 0 to 100 (operationalized for participants in this study as 0=totally relaxed or no anxiety at all and 100=highest distress or anxiety ever felt.

Countries

United States