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

  • STATUS
    Recruiting
  • End date
    Feb 28, 2023
  • participants needed
    600
  • sponsor
    VistaGen Therapeutics, Inc.
Updated on 8 December 2021

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.

Details
Condition Claustrophobia, Phobia, Social, Social Anxiety Disorder (SAD), Social Phobia
Treatment PH94B
Clinical Study IdentifierNCT05030350
SponsorVistaGen Therapeutics, Inc.
Last Modified on8 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and female adults, 18 through 65 years of age, inclusive
Women of childbearing potential must be able to commit to the consistent and correct use of an effective method of birth control throughout the study, and must also have a negative urine pregnancy test result at both Screening (Visit 1) (for subjects who attend Visit 1) and Baseline (Visit 2), prior to IP administration. Effective methods of contraception include: condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), or implantable contraceptive devices
Current diagnosis of social anxiety disorder
Clinician-rated HAM-D17 total score < 18 at study entry
LSAS score 50 or greater

Exclusion Criteria

Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, psychosis, anorexia or bulimia, autism-spectrum disorder, or obsessive-compulsive disorder. Any other current Axis I disorder, other than SAD, which is the primary focus of treatment. Note that subjects with concurrent Generalized Anxiety Disorder are eligible for the study provided that Generalized Anxiety Disorder is not the primary diagnosis
Subjects who meet criteria for moderate or severe alcohol or substance use disorder within the 1 year 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
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
An acute or chronic condition, including an infectious illness, uncontrolled seasonal allergies at the time of the study, or significant nasal congestion that potentially could affect drug delivery to the nasal chemosensory epithelium
Subjects using the following psychotropic medications: anticonvulsants, mood stabilizers, antipsychotic medications, gabapentin, pregabalin, opioids, naltrexone, esketamine, and ketamine at enrollment
Subjects using lower doses of atypical antipsychotics at Screening may be
eligible after discussion with the Medical Monitor (e.g., quetiapine < 100
mg)
In general, subjects using antidepressants or buspirone can continue to
receive these provided that they have been taking them for a minimum of 2
months, and have been on a stable dose for a minimum of 1 month
\. Use of anxiolytics, such as benzodiazepines or unapproved treatments such
as beta blockers, within 30 days before study entry; concomitant use is
prohibited during the study. Subjects who have been taking benzodiazepines
daily for 1 month or longer at the time of Visit 1 are not eligible to
participate
\. Use of any over-the-counter product, prescription product, or herbal
preparation for treatment of the symptoms of anxiety or social anxiety within
days before study entry; concomitant use is prohibited during the study
\. Subjects with clinically significant abnormalities in hematology, blood
chemistry, urinalysis, 12-lead ECG, or physical examination identified at the
Screening visit or Baseline visit that in the clinical judgment of the
Investigator, could place the subject at undue risk, interfere with study
participation, or confound the results of the study
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