[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578275":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":29,"centralContacts":36,"locations":42,"responsibleParty":129,"collaborators":29,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":29,"eligibilityCriteria":137,"healthyVolunteers":133,"sex":138,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":29,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":45,"whyStopped":29,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},{"fullName":5,"class":6},"VistaGen Therapeutics, Inc.","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Fasedienol Nasal Spray (single dose)","EXPERIMENTAL","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.",[13],"Drug: Fasedienol Nasal Spray - Placebo Nasal Spray",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[18],"Drug: Fasedienol Nasal Spray - Fasedienol Nasal Spray",{"label":20,"type":10,"description":21,"interventionNames":22},"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.",[23],"Drug: Placebo Nasal Spray - Placebo Nasal Spray",[25,30,33],{"type":26,"name":27,"description":11,"armGroupLabels":28,"otherNames":29},"DRUG","Fasedienol Nasal Spray - Placebo Nasal Spray",[9],null,{"type":26,"name":31,"description":16,"armGroupLabels":32,"otherNames":29},"Fasedienol Nasal Spray - Fasedienol Nasal Spray",[15],{"type":26,"name":34,"description":21,"armGroupLabels":35,"otherNames":29},"Placebo Nasal Spray - Placebo Nasal Spray",[20],[37],{"name":38,"role":39,"phone":40,"phoneExt":29,"email":41},"Clinical Studies Vistagen Therapeutics, Inc.","CONTACT","650-577-3693","clinicalstudies@vistagen.com",[43,57,65,74,83,92,101,111,120],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":29},"Vistagen Clinical Site","RECRUITING","Sherman Oaks","California","91403","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-118.44925,34.15112,{"lat":55,"lon":54},{"facility":44,"status":45,"city":58,"state":47,"zip":59,"country":49,"countryCode":50,"cosmosGeoPoint":60,"geoPoint":64,"contacts":29},"Walnut Creek","94596",{"type":52,"coordinates":61},[62,63],-122.06496,37.90631,{"lat":63,"lon":62},{"facility":44,"status":45,"city":66,"state":67,"zip":68,"country":49,"countryCode":50,"cosmosGeoPoint":69,"geoPoint":73,"contacts":29},"Largo","Florida","33777",{"type":52,"coordinates":70},[71,72],-82.78842,27.90979,{"lat":72,"lon":71},{"facility":44,"status":45,"city":75,"state":76,"zip":77,"country":49,"countryCode":50,"cosmosGeoPoint":78,"geoPoint":82,"contacts":29},"Saint Charles","Missouri","63304",{"type":52,"coordinates":79},[80,81],-90.48123,38.78394,{"lat":81,"lon":80},{"facility":44,"status":45,"city":84,"state":85,"zip":86,"country":49,"countryCode":50,"cosmosGeoPoint":87,"geoPoint":91,"contacts":29},"Toms River","New Jersey","08755",{"type":52,"coordinates":88},[89,90],-74.19792,39.95373,{"lat":90,"lon":89},{"facility":44,"status":45,"city":93,"state":94,"zip":95,"country":49,"countryCode":50,"cosmosGeoPoint":96,"geoPoint":100,"contacts":29},"Cary","North Carolina","27511",{"type":52,"coordinates":97},[98,99],-78.78112,35.79154,{"lat":99,"lon":98},{"facility":44,"status":102,"city":103,"state":104,"zip":105,"country":49,"countryCode":50,"cosmosGeoPoint":106,"geoPoint":110,"contacts":29},"TERMINATED","Cleveland","Ohio","44130",{"type":52,"coordinates":107},[108,109],-81.69541,41.4995,{"lat":109,"lon":108},{"facility":44,"status":45,"city":112,"state":113,"zip":114,"country":49,"countryCode":50,"cosmosGeoPoint":115,"geoPoint":119,"contacts":29},"Plymouth Meeting","Pennsylvania","19462",{"type":52,"coordinates":116},[117,118],-75.27435,40.10233,{"lat":118,"lon":117},{"facility":44,"status":102,"city":121,"state":122,"zip":123,"country":49,"countryCode":50,"cosmosGeoPoint":124,"geoPoint":128,"contacts":29},"Plano","Texas","75093",{"type":52,"coordinates":125},[126,127],-96.69889,33.01984,{"lat":127,"lon":126},{"type":130,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100578275","phase-2-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-100578275",false,"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","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","Inclusion Criteria:\n\n* Written informed consent provided prior to conducting any study-specific assessment.\n* Male and female adults, 18 through 65 years of age, inclusive.\n* 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).\n* Clinician-rated Liebowitz Social Anxiety Score (LSAS) total score ≥70 at Screening (Visit 1).\n* Clinician-rated Hamilton Depression Rating Scale (HAM-D) (17-items) total score \\\u003C16.\n* 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\n* Subjects must have normal olfactory function\n\nExclusion Criteria:\n\n* 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.\n* 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.\n* 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.\n* 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.\n* 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.\n* Two or more documented failed adequate treatment trials with a registered medication approved for SAD.\n* Currently receiving cognitive-behavioral therapy (CBT), exposure therapy, or acceptance and commitment therapy.\n* Subjects taking psychotropic medications within 30 days before Visit 2.\n* 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.\n* Prior participation in a clinical trial involving fasedienol.\n* Participation in any other clinical trial within the last 30 days or during the course of the current trial.\n* Subjects with a positive urine drug screen.\n* Women who have a positive urine pregnancy test.\n* Women who are currently breastfeeding are not eligible unless they are willing to stop breastfeeding for the duration of the study.\n* Subjects who have tested positive and\u002For have exhibited symptoms consistent with SARS-CoV-2 infection during the 4 weeks prior to Screening (Visit 1).\n* 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.","ALL","18 Years","65 Years",{"count":142,"type":143},60,"ESTIMATED","INTERVENTIONAL",[146],"PHASE2","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.",[149],"Social Anxiety Disorder",[151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168],"Fasedienol","PH94B","social anxiety disorder","social anxiety","SAD","pherine","pherine nasal spray","acute treatment","anxiolytic","mental health","performance anxiety","anxiety nasal spray","anxiety treatment","public speaking anxiety","social phobia","phobic disorders","mental disorder","speech task","2026-02-03",{"date":171,"type":172},"2026-02-05","ACTUAL",{"date":174,"type":172},"2025-01-09",{"date":176,"type":143},"2026-12",{"name":5,"class":6},9]