A US, Phase 3 Multicenter, Randomized, Double-blind, Placebo Controlled Trial of PH94B Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects With Social Anxiety Disorder (PaliSADe-2)
Overview
- Phase
- Phase 3
- Intervention
- PH94B Nasal Spray
- Conditions
- Social Anxiety Disorder
- Sponsor
- VistaGen Therapeutics, Inc.
- Enrollment
- 228
- Locations
- 2
- Primary Endpoint
- Subjective Units of Distress Scale (SUDS)
- Status
- Terminated
- Last Updated
- 5 months ago
Overview
Brief 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.
Investigators
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.
- •Clinician-rated LSAS total score ≥70 at Screening (Visit 1).
- •Clinician-rated Hamilton Depression Score 17-items total score \<18 at Screening (Visit 1).
- •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.
- •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
- •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.
- •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, or
- •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
- •At Screening (Visit 1): the subject has had 1 or more suicidal attempts with reference to a 2 year period prior to screening; or
- •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
- •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.
- •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.
Arms & Interventions
PH94B
3.2 micrograms PH94B intranasal spray (100 microliters to each nostril) one time
Intervention: PH94B Nasal Spray
Placebo
Placebo intranasal spray (100 microliters to each nostril) one time
Intervention: Placebo Nasal Spray
Outcomes
Primary Outcomes
Subjective Units of Distress Scale (SUDS)
Time Frame: Visit 2 (Baseline; Day 0) to Visit 3 (Day 7 ± 2 days)
The SUDS is a patient self-rated scale that is scored in the range of 0 to 100 (operationalized for participants in this study as 0=totally relaxed or no anxiety and 100=highest distress or anxiety ever felt
Secondary Outcomes
- Proportions (%) of CGI-I Responders in PH94B-treated and Placebo-treated Groups at the End of Visit 3 (Treatment)(Visit 2 (Baseline; Day 0) to Visit 3 (Day 7 ± 2 days))