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PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge (Palisade-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04754802
Recruitment Status : Completed
First Posted : February 15, 2021
Last Update Posted : June 23, 2022
Sponsor:
Information provided by (Responsible Party):
VistaGen Therapeutics, Inc.

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.


Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Drug: PH94B Nasal Spray Drug: Placebo Nasal Spray Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of PH94B Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects With Social Anxiety Disorder
Actual Study Start Date : May 24, 2021
Actual Primary Completion Date : June 22, 2022
Actual Study Completion Date : June 22, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: PH94B
3.2 micrograms PH94B intranasal spray (100 microliters to each nostril) one time
Drug: PH94B Nasal Spray
Nasal spray delivered 20 minutes before the public speaking stressor

Experimental: Placebo
Placebo intranasal spray (100 microliters to each nostril) one time
Drug: Placebo Nasal Spray
Nasal spray delivered 20 minutes before the public speaking stressor




Primary Outcome Measures :
  1. Subjective Units of Distress Scale (SUDS) [ Time Frame: 20 minutes ]
    0-100 self-report scale of level of anxiety


Secondary Outcome Measures :
  1. Clinical Global Impression - Improvement [ Time Frame: 20 minutes ]
    Investigator-reported impression



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent provided prior to conducting any study-specific assessment.
  2. Male or female adult, 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, as confirmed by the Mini-International Neuropsychiatric Interview (MINI).
  4. Clinician-rated Liebowitz Social Anxiety Scale (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 child bearing-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 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, 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 considered to be an imminent danger to themselves or others.
  4. Clinically significant nasal pathology or history of significant nasal trauma, nasal surgery, 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, taken at any time during the lifetime of the patient, whereby an adequate treatment trial is defined as that documented 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 allowed medication for insomnia.
  8. Concomitant use of any anxiolytics, such as benzodiazepines or unapproved treatments such as beta blockers, during the Study and within 30 days before Study entry.
  9. Concomitant use of any over-the-counter, prescription product, or herbal preparation for treatment of the symptoms of anxiety or social anxiety during the Study and within 30 days before Study entry.
  10. Prior participation in a clinical trial involving PH94B.
  11. Women who have a positive serum or 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.
  13. Subjects with a positive urine drug screen at either the Screening visit or Baseline visit (not including tetrahydrocannabinol).
  14. Any current clinically significant and/or uncontrolled medical condition, based on medical history or as evidenced in screening assessments, such as SARS-Cov-2, HIV, cancer, stroke, congestive heart failure, uncontrolled diabetes mellitus, or any other medical condition or disease 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.
  15. History of cancer or malignant tumor not in remission for at least 2 years. Basal cell skin cancers are not exclusionary.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04754802


Locations
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United States, California
VistaGen Clinical Site
Los Angeles, California, United States, 90024
VistaGen Clinical Site
Orange, California, United States, 92868
VistaGen Clinical Site
Riverside, California, United States, 92503
VistaGen Clinical Site
San Diego, California, United States, 92103
VistaGen Clinical Site
San Jose, California, United States, 95124
VistaGen Clinical Site
Sherman Oaks, California, United States, 91403
United States, Florida
VistaGen Clinical Sites
Fort Myers, Florida, United States, 33912
VistaGen Clinical Site
Jacksonville, Florida, United States, 32256
VistaGen Clinical Site
Orlando, Florida, United States, 32801
VistaGen Clinical Site
Tampa, Florida, United States, 33614
United States, Illinois
VistaGen Clinical Site
Chicago, Illinois, United States, 60640
United States, Massachusetts
VistaGen Clinical Site
Watertown, Massachusetts, United States, 02472
United States, New Jersey
VistaGen Clinical Site
Princeton, New Jersey, United States, 08540
United States, New York
VistaGen Clinical Site
New York, New York, United States, 10128
United States, Oklahoma
VistaGen Clinical Site
Oklahoma City, Oklahoma, United States, 73106
United States, Pennsylvania
VistaGen Clinical Site
Allentown, Pennsylvania, United States, 18104
VistaGen Clinical Site
Media, Pennsylvania, United States, 19063
United States, Texas
VistaGen Clinical Site
Houston, Texas, United States, 77030
VistaGen Clinical Site
San Antonio, Texas, United States, 78229
United States, Vermont
VistaGen Clinical Site
Woodstock, Vermont, United States, 05091
United States, Washington
VistaGen Clinical Site
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
VistaGen Therapeutics, Inc.
Investigators
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Principal Investigator: Michael Liebowitz, MD Medical Research Network
Publications:
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Responsible Party: VistaGen Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04754802    
Other Study ID Numbers: PH94B-CL026
First Posted: February 15, 2021    Key Record Dates
Last Update Posted: June 23, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Phobia, Social
Mental Disorders
Phobic Disorders