A Clinical Trial to Assess the Efficacy, Safety, and Tolerability of a Repeat Dose of Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder

Part of paid clinical trials in Sherman Oaks, California.

Sponsor
VistaGen Therapeutics, Inc.
Study ID
NCT06809179
Phase
PHASE2
Status
Recruiting
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Conditions

  • Social Anxiety Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Fasedienol Nasal Spray - Placebo Nasal Spray — DRUG
    Twenty minutes prior to the PSC, subjects will receive one dose of Fasedienol Nasal Spray followed by one dose of Placebo Nasal Spray, separated by 10-minutes in between the two doses.
  • Fasedienol Nasal Spray - Fasedienol Nasal Spray — DRUG
    Twenty minutes prior to the PSC, subjects will receive one dose of Fasedienol Nasal Spray followed by a second dose of Fasedienol Nasal Spray, separated by 10-minutes in between the two doses.
  • Placebo Nasal Spray - Placebo Nasal Spray — DRUG
    Twenty minutes prior to the PSC, subjects will receive one dose of Placebo Nasal Spray followed by a second dose of Placebo Nasal Spray, separated by 10-minutes between the two doses.

Study Details

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.

Key Dates

Start date
Jan 9, 2025
Status verified
Feb 2026
Primary completion
Apr 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fasedienol Nasal Spray (single dose)
    Twenty minutes prior to the PSC, subjects will receive one dose of Fasedienol Nasal Spray followed by one dose of Placebo Nasal Spray, separated by 10-minutes in between the two doses.
  • Experimental: Fasedienol Nasal Spray (repeat dose)
    Twenty minutes prior to the PSC, subjects will receive one dose of Fasedienol Nasal Spray followed by a second dose of Fasedienol Nasal Spray, separated by 10-minutes in between the two doses.
  • Experimental: Placebo Nasal Spray
    Twenty minutes prior to the PSC, subjects will receive one dose of Placebo Nasal Spray followed by a second dose of Placebo Nasal Spray, separated by 10-minutes between the two doses.

Primary Outcome Measure

Subjective Units of Distress Scale (SUDS) [ Time Frame: 7 days (Visit 2 to Visit 3) ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Vistagen Clinical SiteSherman OaksCalifornia91403-
Vistagen Clinical SiteWalnut CreekCalifornia94596-
Vistagen Clinical SiteLargoFlorida33777-
Vistagen Clinical SiteSaint CharlesMissouri63304-
Vistagen Clinical SiteToms RiverNew Jersey08755-
Vistagen Clinical SiteCaryNorth Carolina27511-
Vistagen Clinical SiteClevelandOhio44130-
Vistagen Clinical SitePlymouth MeetingPennsylvania19462-
Vistagen Clinical SitePlanoTexas75093-

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Vistagen Clinical Site· Sherman Oaks, CAVistagen Clinical Site· Walnut Creek, CAVistagen Clinical Site· Largo, FLVistagen Clinical Site· Saint Charles, MOVistagen Clinical Site· Toms River, NJVistagen Clinical Site· Cary, NC

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