NCT05030350

Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD)

A Phase 3 Open-label Safety Trial of PH94B Nasal Spray in the Acute Treatment of Anxiety in Adult Subjects With Social Anxiety Disorder (SAD)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 481 (actual)
• Sponsor: VistaGen Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the safety and tolerability of PH94B with repeated dosing over a period of up to 12 months. Participating subjects will use PH94B up to 4 times a day when they encounter anxiety-provoking situations in daily life. Safety and tolerability of PH94B (≤ 4 doses per day up to 12 months) will be assessed and summarized during monthly visits from baseline (Visit 2) to end of treatment (Visit 14) in AEs, laboratory values, 12-lead ECGs, physical examinations, and vital sign assessments following exposure to PH94B.

Conditions

• Social Anxiety Disorder

Interventions

Type	Name	Description
DRUG	PH94B	Nasal spray

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-09-23
• Completion: 2022-09-23
• First posted: 2021-09-01
• Last updated: 2025-10-21
• Results posted: 2025-10-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study