PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge
Summary
This 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.
Timeline
- Start
- 2021-05-24
- Primary completion
- 2022-06-22
- Completion
- 2022-06-22
Outcome
Missed primary endpoint
registry analysis (superiority test); PH94B vs Placebo; p = .5063; Mean Difference (Net) 1.6 (95% CI -3.2 to 6.4); ANCOVA NCT04754802 ↗
release “Although the trial did not meet its primary endpoint, the tolerability profile of PH94B in PALISADE-1 was favorable” vistagen.com ↗
release “PH94B did not achieve its primary efficacy endpoint during PALISADE-1, a single administration assessment Phase 3 trial” vistagen.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fasedienol | Small molecule | 3.2 ug | Intranasal |