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NCT05030350 · ClinicalTrials.gov registry record · Phase 3
Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD)
A Phase 3 study, sponsored by VistaGen Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 481
- Enrollment target
NCT05030350: Clinical Trial Phase 3 study, sponsored by VistaGen Therapeutics.
NCT05030350 is a Phase 3 study that was terminated before completion, run by VistaGen Therapeutics. The registered enrollment target is 481 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05030350, a Phase 3 study, was terminated before completion, sponsored by VistaGen Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 481 participants
- Enrollment target
Study Summary
This study evaluates the safety and tolerability of PH94B with repeated dosing over a period of up to 12 months. Participating subjects will use PH94B up to 4 times a day when they encounter anxiety-provoking situations in daily life. Safety and tolerability of PH94B (≤ 4 doses per day up to 12 months) will be assessed and summarized during monthly visits from baseline (Visit 2) to end of treatment (Visit 14) in AEs, laboratory values, 12-lead ECGs, physical examinations, and vital sign assessments following exposure to PH94B.
Primary Outcome
Subjects with at least one Serious Adverse Event (SAE)
Interventions
- DRUG PH94B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 481 participants |
| Start Date | 2021-10-01 |
| Est. Completion | 2022-09-23 |
| Phase | Phase 3 |
Why NCT05030350 stopped before completion
NCT05030350 is an interventional study that assigns participants to a tested intervention. The registered 481 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 (38% lower).
The record links to 0 conditions, and to 1 intervention - of which PH94B is the first listed.
NCT05030350 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05030350 about?
NCT05030350 is a clinical study titled "Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD)". This study evaluates the safety and tolerability of PH94B with repeated dosing over a period of up to 12 months. Participating subjects will use PH94B up to 4 times a day when they encounter anxiety-provoking situations in daily life. Safety and tolerability of PH94B (≤ 4 doses per day up to 12 mont...
What is the current status of trial NCT05030350?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 481 participants. The study started on 2021-10-01. Estimated completion is 2022-09-23.
What interventions are being tested in trial NCT05030350?
The interventions under investigation include: PH94B (DRUG).
Who is sponsoring clinical trial NCT05030350?
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 NCT05030350's enrollment target sits among peer trials
481 792nd of 2000 higher than 1,209 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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