Fasedienol næsespray til akut behandling af angst hos voksne med social angst (PALISADE-3) (PALISADE-3)
30. oktober 2026 opdateret af: VistaGen Therapeutics, Inc.
USA, fase 3, multicenter, randomiseret, dobbeltblindet, placebokontrolleret klinisk forsøg med Fasedienol næsespray til akut behandling af angst induceret af en offentlig taleudfordring hos voksne personer med social angstlidelse, med en åben udvidelse (PALISADE) -3)
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-3 and choose to enter the distinct open-label extension phase of the study.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
238
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arizona
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Phoenix, Arizona, Forenede Stater, 85012
- Vistagen Clinical Site
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Arkansas
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Fayetteville, Arkansas, Forenede Stater, 72703
- Vistagen Clinical Site
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Little Rock, Arkansas, Forenede Stater, 72211
- Vistagen Clinical Site
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California
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Lafayette, California, Forenede Stater, 94549
- Vistagen Clinical Site
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Oceanside, California, Forenede Stater, 92056
- Vistagen Clinical Site
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Sherman Oaks, California, Forenede Stater, 91403
- Vistagen Clinical Site
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Colorado
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Denver, Colorado, Forenede Stater, 80209
- Vistagen Clinical Site
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Connecticut
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Cromwell, Connecticut, Forenede Stater, 06416
- Vistagen Clinical Site
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Florida
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Jacksonville, Florida, Forenede Stater, 32256
- Vistagen Clinical Site
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Lakeland, Florida, Forenede Stater, 33803
- Vistagen Clinical Site
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Orlando, Florida, Forenede Stater, 32801
- Vistagen Clinical Site
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West Palm Beach, Florida, Forenede Stater, 33407
- Vistagen Clinical Site
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Vistagen Clinical Site
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Kansas
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Overland Park, Kansas, Forenede Stater, 66210
- Vistagen Clinical Site
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Maryland
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Baltimore, Maryland, Forenede Stater, 21208
- Vistagen Clinical Site
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02131
- Vistagen Clinical Site
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Missouri
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Saint Charles, Missouri, Forenede Stater, 63304
- Vistagen Clinical Site
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89119
- Vistagen Clinical Site
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New York
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New York, New York, Forenede Stater, 10128
- Vistagen Clinical Site
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Pennsylvania
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Media, Pennsylvania, Forenede Stater, 19063
- Vistagen Clinical Site
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38119
- Vistagen Clinical Site
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Texas
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Fort Worth, Texas, Forenede Stater, 76104
- Vistagen Clinical Site
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Utah
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Draper, Utah, Forenede Stater, 84020
- Vistagen Clinical Site
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Washington
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Everett, Washington, Forenede Stater, 98201
- Vistagen Clinical Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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 (DSM-5), and confirmed by the Mini-International Neuropsychiatric Interview (MINI).
- Clinician-rated Liebowitz Social Anxiety Scale (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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Placebo komparator: Placebo næsespray
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Nasal spray delivered 20 minutes before the PSC |
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Eksperimentel: Fasedienol næsespray
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Nasal spray delivered 20 minutes before the PSC |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Subjective Units of Distress Scale (SUDS)
Tidsramme: 7 days (Visit 2 to Visit 3)
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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). |
7 days (Visit 2 to Visit 3)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Global Impression Scale of Improvement (CGI-I)
Tidsramme: 7 days (Visit 2 to Visit 3)
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The CGI-I scale is a clinician-rated scale to assess illness improvement. The CGI-I scale includes one item being scored from 1 (best outcome) to 7 (worst outcome) with 4 being no change. |
7 days (Visit 2 to Visit 3)
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Patient Global Impression of Change (PGI-C)
Tidsramme: 7 days (Visit 2 to Visit 3)
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The PGI-C is a patient self-rated scale to assess improvement. The PGI-C includes 7 items being scored from 1 (best outcome) to 7 (worst outcome) with 4 being no change. |
7 days (Visit 2 to Visit 3)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
28. marts 2024
Primær færdiggørelse (Faktiske)
31. oktober 2025
Studieafslutning (Faktiske)
13. juli 2026
Datoer for studieregistrering
Først indsendt
4. april 2024
Først indsendt, der opfyldte QC-kriterier
4. april 2024
Først opslået (Faktiske)
10. april 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. oktober 2026
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PH94B-CL042
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ja
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Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .