En amerikansk dobbeltblind, placebokontrollert fase 2 klinisk studie for å vurdere effektiviteten, sikkerheten og toleransen av en gjentatt dose fasedienol nesespray for akutt behandling av angst hos voksne med sosial angstlidelse
En fase 2, tre-arm, multisenter, randomisert, dobbeltblind, placebokontrollert klinisk studie for å vurdere effektiviteten, sikkerheten og toleransen av en gjentatt dose fasedienol (pH94B) nesespray for akutt behandling av angst indusert av en Offentlig talekalling hos voksne fag med sosial angstlidelse, med en åpenhetsutvidelse
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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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California
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Sherman Oaks, California, Forente stater, 91403
- Vistagen Clinical Site
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Walnut Creek, California, Forente stater, 94596
- Vistagen Clinical Site
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Florida
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Largo, Florida, Forente stater, 33777
- Vistagen Clinical Site
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Missouri
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Saint Charles, Missouri, Forente stater, 63304
- Vistagen Clinical Site
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New Jersey
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Toms River, New Jersey, Forente stater, 08755
- Vistagen Clinical Site
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North Carolina
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Cary, North Carolina, Forente stater, 27511
- Vistagen Clinical Site
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Ohio
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Cleveland, Ohio, Forente stater, 44130
- Vistagen Clinical Site
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Pennsylvania
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Plymouth Meeting, Pennsylvania, Forente stater, 19462
- Vistagen Clinical Site
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Texas
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Plano, Texas, Forente stater, 75093
- Vistagen Clinical Site
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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, 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 <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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Fasedienol Nasal Spray (single dose)
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. |
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. |
|
Eksperimentell: 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. |
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. |
|
Eksperimentell: 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. |
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Subjective Units of Distress Scale (SUDS)
Tidsramme: 7 days (Visit 2 to Visit 3)
|
The SUDS is a patient self-rated acute measurement scale that is scored in the range of 0 to 100 (operationalized for participants in this study as 0=totally relaxed or no anxiety at all and 100=highest distress or anxiety ever felt. |
7 days (Visit 2 to Visit 3)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Global Impression Scale of Improvement (CGI-I)
Tidsramme: 7 days (Visit 2 to Visit 3)
|
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)
|
|
Patient Global Impression of Change (PGI-C)
Tidsramme: 7 days (Visit 2 to Visit 3)
|
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)
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PH94B-CL036
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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