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NCT05011396 · ClinicalTrials.gov registry record · Phase 3
PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge - 2
A Phase 3 study, sponsored by VistaGen Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 228
- Enrollment target
NCT05011396: Clinical Trial Phase 3 study, sponsored by VistaGen Therapeutics.
NCT05011396 is a Phase 3 study that was terminated before completion, run by VistaGen Therapeutics. The registered enrollment target is 228 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05011396, a Phase 3 study, was terminated before completion, sponsored by VistaGen Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 228 participants
- Enrollment target
Study 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.
Primary Outcome
The SUDS is a patient self-rated scale that is scored in the range of 0 to 100 (operationalized for participants in this study as 0=totally relaxed or no anxiety and 100=highest distress or anxiety ever felt
Interventions
- DRUG Placebo Nasal Spray
- DRUG PH94B Nasal Spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 228 participants |
| Start Date | 2021-08-30 |
| Est. Completion | 2022-08-16 |
| Phase | Phase 3 |
Why NCT05011396 stopped before completion
NCT05011396 is an interventional study that assigns participants to a tested intervention. The registered 228 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Nasal Spray is the first listed.
NCT05011396 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05011396 about?
NCT05011396 is a clinical study titled "PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge - 2". 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 Stu...
What is the current status of trial NCT05011396?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 228 participants. The study started on 2021-08-30. Estimated completion is 2022-08-16.
What interventions are being tested in trial NCT05011396?
The interventions under investigation include: Placebo Nasal Spray (DRUG), PH94B Nasal Spray (DRUG).
Who is sponsoring clinical trial NCT05011396?
This trial is sponsored by VistaGen Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05011396's enrollment target sits among peer trials
228 1309th of 2000 higher than 691 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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