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PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge - 2 (Palisade-2)

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ClinicalTrials.gov Identifier: NCT05011396
Recruitment Status : Recruiting
First Posted : August 18, 2021
Last Update Posted : December 2, 2021
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)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : August 30, 2021
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : September 1, 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 and female adults, 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, and confirmed by the MINI.
  4. Clinician-rated 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 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.
  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, 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.

  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

    1. 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
    2. At Screening (Visit 1): the subject has had 1 or more suicidal attempts with reference to a 2 year period prior to screening; or
    3. 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
    4. The subject is considered to be an imminent danger to themself or others.
  4. 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.
  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, at any time during the lifetime of the subject, whereby an adequate treatment trial is defined as that described 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 medication permitted for insomnia: eszopiclone, ramelteon, melatonin, zaleplon, zolpidem, or antihistamines).
  8. Use of any anxiolytics, such as benzodiazepines or unapproved treatments such as beta blockers, within 30 days before study entry; concomitant use is prohibited during the study. Subjects who have been taking benzodiazepines daily for 1 month or longer at the time of Visit 1 are not eligible to participate.
  9. Use of any over-the-counter product, prescription product, or herbal preparation for treatment of the symptoms of anxiety or social anxiety within 30 days before study entry; concomitant use is prohibited during the study.
  10. Prior participation in a clinical trial involving PH94B.
  11. Women who have a positive 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.

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): NCT05011396


Contacts
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Contact: Cherilyn Boller 1 860-200-6465 Palisades2@premier-research.com

Locations
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United States, Arizona
VistaGen Clinical Site Recruiting
Phoenix, Arizona, United States, 85012
United States, California
VistaGen Clinical Site Recruiting
Garden Grove, California, United States, 92845
VistaGen Clinical Site Recruiting
Oceanside, California, United States, 92056
VistaGen Clinical Site Recruiting
Temecula, California, United States, 92591
United States, Georgia
VistaGen Clinical Site Recruiting
Alpharetta, Georgia, United States, 30022
United States, Kansas
VistaGen Clinical Site Recruiting
Prairie Village, Kansas, United States, 66208
United States, Massachusetts
VistaGen Clinical Site Recruiting
Boston, Massachusetts, United States, 02131
United States, Mississippi
VistaGen Clinical Site Recruiting
Flowood, Mississippi, United States, 39232
United States, New Jersey
VistaGen Clinical Site Recruiting
Berlin, New Jersey, United States, 08009
United States, New York
VistaGen Clinical Site Recruiting
Brooklyn, New York, United States, 11235
VistaGen Clinical Site Recruiting
New York, New York, United States, 10032
VistaGen Clinical Site Recruiting
Rochester, New York, United States, 14618
United States, Pennsylvania
VistaGen Clinical Center Recruiting
Allentown, Pennsylvania, United States, 18104
United States, Tennessee
VistaGen Clinical Site Recruiting
Memphis, Tennessee, United States, 38119
United States, Texas
VistaGen Clinical Site Recruiting
Austin, Texas, United States, 78737
Sponsors and Collaborators
VistaGen Therapeutics, Inc.
Investigators
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Principal Investigator: Michael Liebowitz Medical Research Network
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Responsible Party: VistaGen Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05011396    
Other Study ID Numbers: PH94B-CL032
First Posted: August 18, 2021    Key Record Dates
Last Update Posted: December 2, 2021
Last Verified: August 2021

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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