A U.S. Double-blind, Placebo-controlled Phase 2 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
Purpose
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.
Condition
- Social Anxiety Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- VistaGen Therapeutics, Inc.
Study Contact
Clinical Studies Vistagen Therapeutics, Inc.650-577-3693
clinicalstudies@vistagen.com
