Uno studio clinico di fase 2 in doppio cieco, controllato con placebo, controllato con placebo per valutare l'efficacia, la sicurezza e la tollerabilità di una dose ripetuta di spray nasale fasedienolo per il trattamento acuto dell'ansia negli adulti con disturbo dell'ansia sociale
Un studio clinico di fase 2, a tre bracci, multicentrico, randomizzato, in doppio cieco, controllato con placebo per valutare l'efficacia, la sicurezza e la tollerabilità di una dose ripetuta di spray nasale di Fasedienolo (PH94b) per il trattamento acuto dell'ansia indotta da a Sfida di parlare in pubblico in argomenti adulti con disturbo d'ansia sociale, con un'estensione in aperto
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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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California
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Sherman Oaks, California, Stati Uniti, 91403
- Vistagen Clinical Site
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Walnut Creek, California, Stati Uniti, 94596
- Vistagen Clinical Site
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Florida
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Largo, Florida, Stati Uniti, 33777
- Vistagen Clinical Site
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Missouri
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Saint Charles, Missouri, Stati Uniti, 63304
- Vistagen Clinical Site
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New Jersey
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Toms River, New Jersey, Stati Uniti, 08755
- Vistagen Clinical Site
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North Carolina
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Cary, North Carolina, Stati Uniti, 27511
- Vistagen Clinical Site
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Ohio
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Cleveland, Ohio, Stati Uniti, 44130
- Vistagen Clinical Site
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Pennsylvania
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Plymouth Meeting, Pennsylvania, Stati Uniti, 19462
- Vistagen Clinical Site
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Texas
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Plano, Texas, Stati Uniti, 75093
- Vistagen Clinical Site
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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. |
|
Sperimentale: 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. |
|
Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Subjective Units of Distress Scale (SUDS)
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Global Impression Scale of Improvement (CGI-I)
Lasso di tempo: 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)
Lasso di tempo: 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)
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- salute mentale
- ansia sociale
- disturbo d'ansia sociale
- TRISTE
- fobia sociale
- trattamento dell'ansia
- ansiolitico
- disordine mentale
- trattamento acuto
- disturbi fobici
- ansia di parlare in pubblico
- ansia da prestazione
- Fasedienolo
- PH94B
- perina
- spray nasale alla perina
- spray nasale per l'ansia
- compito vocale
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PH94B-CL036
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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