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PH94B

PH94B in the Treatment of Adjustment Disorder With Anxiety

Ensayo de Vistagen Therapeutics, Inc. en Adjustment Disorder With Anxious Mood (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

41

previstos

Centros

2

Fin del objetivo primario

dic 2022

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en oct 2021.

Qué mide

Hamilton Anxiety Scale (HAM-A) Score (del registro, en inglés) (28 dias)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis placebo-controlled clinical study is designed to evaluate the efficacy, safety and tolerability of administration of PH94B nasal spray four times per day as a treatment of Adjustment Disorder with Anxiety symptoms in adults. Subject participation in the Study will last a total of 6 to 10 weeks, depending on the duration of the screening period and whether they need a washout of concomitant anxiolytics. Upon signing an investigation review board approved informed consent, all subjects will complete Visit 1 (Screening) and enter a screening period lasting 7 to 35 days that could include taper of concomitant anxiolytics, if necessary. Screening visit will consist of safety assessments (medical history, physical examination, laboratory samples, electrocardiogram, urine drug screen, and urine pregnancy test \[if appropriate\]) and psychiatric assessments to determine eligibility. Subjects will then return to complete Visit 2 (Baseline). If the subject continues to meet inclusion and exclusion criteria, the subject will be randomized 1:1 to PH94B or placebo. Subjects will then commence 4 weeks of double-blind treatment with randomized investigational product (PH94B or placebo) four times per day. Subjects will return for weekly site visits (Visits 3, 4, 5, and 6), in which the subject will return the vial dispensed at the previous visit and receive a new vial, except at Visit 6 in which no new vial will be dispensed. Changes in AEs and concomitant medications will be collected. During these visits, psychiatric scales will be completed. When the subject returns for Visit 6, besides the assessments completed at Visits 3 through 5, the subjects will complete a brief physical examination, electrocardiogram, laboratory tests (chemistry and blood), and urinalysis. Any remaining IP vials will be collected. The subject will then come back after a one week washout period for Follow-up visit (Visit 7).

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Ficha completa en ClinicalTrials.gov (NCT04404192), actualizada en ene 2026.