Calendario›VTGN›PH94B Nasal Spray · Palisade-1
PH94B Nasal Spray · Palisade-1
PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge
Ensayo de Vistagen Therapeutics, Inc. en trastorno de ansiedad social.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 224
- Centros
- 21
- Fin del objetivo primario
- jun 2022
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, triple ciego. Comenzó en may 2021.
Qué mide
Puntuacion de la Subjective Units of Distress Scale (SUDS) (Visit 2 (Baseline; Day 0) to Visit 3 (Day 7 ± 2 days)) (del registro, en inglés)
Qué se prueba
Se va a evaluar la eficacia, seguridad y tolerabilidad de una dosis aguda de 3,2 µg de PH94B para aliviar síntomas de ansiedad en adultos con trastorno de ansiedad social durante una prueba de discurso público inducida.
Lo que dice el documentoevaluate 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.
Traducción automática (claude-haiku-4-5-20251001). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis 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.
Más ensayos de VTGN
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Fasedienol Nasal Spray · PALISADE-3 | Fase 3 | En marcha, sin reclutar | oct 2025 (real) |
| Fasedienol Nasal Spray | Fase 2 | Reclutando pacientes | abr 2026 (prevista, ya pasada: sin actualizar en el registro) |
| Fasedienol Nasal Spray · PALISADE-4 | Fase 3 | En marcha, sin reclutar | abr 2026 (real) |
| AV-101 | Fase 2 | Sin noticias del promotor | dic 2023 (prevista, ya pasada: sin actualizar en el registro) |
| PH94B | Fase 2 | Completado | dic 2022 (real) |
| PH94B | Fase 3 | Interrumpido | sep 2022 (real) |
Todos los de VTGN, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04754802), actualizada en ago 2025.