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Recruiting NCT06809179

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

Phase II Interventional Social Anxiety Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fasedienol Nasal Spray - Placebo Nasal Spray, Fasedienol Nasal Spray - Fasedienol Nasal Spray, Placebo Nasal Spray - Placebo Nasal Spray.
Who it may be relevant to
Registry conditions: Social Anxiety Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Fasedienol Nasal Spray - Placebo Nasal Spray
    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.
  • Drug Fasedienol Nasal Spray - Fasedienol Nasal Spray
    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.
  • Drug Placebo Nasal Spray - 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 measures

  • Subjective Units of Distress Scale (SUDS) [Time frame: 7 days (Visit 2 to Visit 3)]
Secondary outcome measures (2)
  • Global Impression Scale of Improvement (CGI-I) [Time frame: 7 days (Visit 2 to Visit 3)]
  • Patient Global Impression of Change (PGI-C) [Time frame: 7 days (Visit 2 to Visit 3)]

Eligibility criteria

Inclusion criteria

  • Written informed consent provided prior to conducting any study-specific assessment.
  • Male and female adults, 18 through 65 years of age, inclusive.
  • Current diagnosis of SAD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, and confirmed by the Mini-International Neuropsychiatric Interview (MINI).
  • Clinician-rated Liebowitz Social Anxiety Score (LSAS) total score ≥70 at Screening (Visit 1).
  • Clinician-rated Hamilton Depression Rating Scale (HAM-D) (17-items) total score <16.
  • Female subjects of childbearing potential must be able to commit to the consistent and correct use of an effective method of birth control throughout the study
  • Subjects must have normal olfactory function

Exclusion criteria

  • Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, psychosis, anorexia or bulimia, premenstrual dysphoric disorder, autism spectrum disorder, or obsessive-compulsive disorder.
  • Any other current principal or personality disorder (previously known as Axis I or Axis II disorders), except for specific phobias or generalized anxiety disorder, provided that these are not the primary diagnosis.
  • Subjects who meet criteria for moderate or severe alcohol use disorder within the 1 year prior to study entry, or any use of illicit substances or tetrahydrocannabinol ("THC") within 2 months prior to study entry.
  • In the opinion of the investigator, the subject has a significant risk for suicidal behavior during the course of their participation in the study, or the subject is considered to be an imminent danger to themself or others.
  • Clinically significant nasal pathology or history of significant nasal trauma, nasal surgery, total anosmia, or nasal septum perforation that may have damaged the nasal chemosensory epithelium.
  • Two or more documented failed adequate treatment trials with a registered medication approved for SAD.
  • Currently receiving cognitive-behavioral therapy (CBT), exposure therapy, or acceptance and commitment therapy.
  • Subjects taking psychotropic medications within 30 days before Visit 2.
  • Use of any over-the-counter product, prescription product, off-label treatment, cannabidiol ("CBD"), or herbal preparation for treatment of the symptoms of anxiety or social anxiety within 30 days before Visit 2.
  • Prior participation in a clinical trial involving fasedienol.
  • Participation in any other clinical trial within the last 30 days or during the course of the current trial.
  • Subjects with a positive urine drug screen.
  • Women who have a positive urine pregnancy test.
  • Women who are currently breastfeeding are not eligible unless they are willing to stop breastfeeding for the duration of the study.
  • Subjects who have tested positive and/or have exhibited symptoms consistent with SARS-CoV-2 infection during the 4 weeks prior to Screening (Visit 1).
  • Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 9 centers
  • Vistagen Clinical Site — Sherman Oaks
  • Vistagen Clinical Site — Walnut Creek
  • Vistagen Clinical Site — Largo
  • Vistagen Clinical Site — Saint Charles
  • Vistagen Clinical Site — Toms River
  • Vistagen Clinical Site — Cary
  • Vistagen Clinical Site — Cleveland
  • Vistagen Clinical Site — Plymouth Meeting
  • … and 1 more center

Identifiers

NCT: NCT06809179 · PH94B-CL036

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗