US, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Fasedienol 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 (PALISADE-4)

VistaGen Therapeutics, Inc.30 个研究点分布在 1 个国家目标入组 236 人2024年9月16日

适应症Social Anxiety Disorder (SAD)

干预措施Fasedienol Nasal Spray Placebo Nasal Spray

概览

阶段: 3 期
干预措施: Fasedienol Nasal Spray
疾病 / 适应症: Social Anxiety Disorder (SAD)
发起方: VistaGen Therapeutics, Inc.
入组人数: 236
试验地点: 30
主要终点: Subjective Units of Distress Scale (SUDS)
状态: 招募中
最后更新: 8天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This U.S. Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute intranasal (i.n.) administration 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 PALISADE-4 and choose to enter the distinct open-label extension phase of the study.

注册库

clinicaltrials.gov

开始日期

2024年9月16日

结束日期

2027年4月1日

最后更新

8天前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

VistaGen Therapeutics, Inc.

责任方

Sponsor

入排标准

入选标准

•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 \<
•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

排除标准

•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
•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
•Prior participation in a clinical trial involving fasedienol.

研究组 & 干预措施

Fasedienol Nasal Spray

干预措施: Fasedienol Nasal Spray

Placebo Nasal Spray

干预措施: Placebo Nasal Spray

结局指标

主要结局

Subjective Units of Distress Scale (SUDS)

时间窗: 7 days (Visit 2 to Visit 3)

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).