Overview
PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge - 2
Status:
Recruiting
Recruiting
Trial end date:
2022-09-01
2022-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute administration of 3.2 µg of PH94B to relieve symptoms of anxiety in adult subjects with social anxiety disorder (SAD) during an induced public speaking challenge. Subject participation in the Study will last a total of 3 to 7 weeks, depending on the duration of the screening period and intervals between visits. Upon signing an informed consent, all subjects will complete Visit 1 (Screening) and enter a screening period lasting between 3 and 35 days. If subjects meet all eligibility criteria at the end of the screening period, subjects will return for Visit 2 and self-administer the nasal spray and then participate in a 5 minute public speaking challenge. During the public speaking challenge, the subject will be asked for their anxiety score, which will be recorded by a trained observer. At Visit 3, the subjects will undergo the same public speaking procedure once again as they did in Visit 2. One week after the completion of the Visit 3 public speaking challenge, the subject will come back for Visit 4 (Follow-up) that will involve a repeat of the safety and psychiatric assessments conducted at Screening.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
VistaGen Therapeutics, Inc.
Criteria
Inclusion Criteria:1. Written informed consent provided prior to conducting any study-specific assessment.
2. Male and female adults, 18 through 65 years of age, inclusive.
3. Current diagnosis of SAD as defined in the Diagnostic and Statistical Manual of Mental
Disorders, 5th Edition, and confirmed by the MINI.
4. Clinician-rated LSAS total score ≥70 at Screening (Visit 1).
5. Clinician-rated Hamilton Depression Score 17-items total score <18 at Screening (Visit
1).
6. 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) and Baseline (Visit
2), prior to investigational product (IP) administration. Effective methods of
contraception include: condoms with spermicide, diaphragm with spermicide, hormonal
contraceptive agents (oral, transdermal, or injectable), or implantable contraceptive
devices.
7. Negative COVID-19 test either in the presence of COVID-19 symptoms or after direct
exposure to someone with a positive COVID-19 test
Exclusion Criteria:
1. 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 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.
2. Subjects who meet criteria for moderate or severe alcohol or substance use disorder
within the 1 year prior to Study entry.
3. 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
1. At Screening (Visit 1): the subject scores "yes" on items 4 or 5 in the Suicidal
Ideation section of the Columbia-Suicide Severity Rating Scale (C SSRS) with
reference to a 6-month period prior to screening; or
2. At Screening (Visit 1): the subject has had 1 or more suicidal attempts with
reference to a 2 year period prior to screening; or
3. At Baseline (Visit 2): the subject scores "yes" on items 4 or 5 in the Suicidal
Ideation section of the C-SSRS with reference to screening; or
4. The subject is considered to be an imminent danger to themself or others.
4. 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.
5. 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.
6. Two or more documented failed treatment trials with a registered medication approved
for SAD, at any time during the lifetime of the subject, whereby an adequate treatment
trial is defined as that described in the package insert for a particular drug during
which the subject received an adequate medication dosage (defined as the treatment
dose indicated in the package insert to obtain efficacy for that particular drug).
7. Use of any psychotropic medication within 30 days before study entry (other than
medication permitted for insomnia: eszopiclone, ramelteon, melatonin, zaleplon,
zolpidem, or antihistamines).
8. Use of any 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.
9. Use of any over-the-counter product, prescription product, or herbal preparation for
treatment of the symptoms of anxiety or social anxiety within 30 days before study
entry; concomitant use is prohibited during the study.
10. Prior participation in a clinical trial involving PH94B.
11. Women who have a positive urine pregnancy test prior to IP administration.
12. Subjects with clinically significant abnormalities in hematology, blood chemistry,
urinalysis, electrocardiogram, 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.