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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 is a Phase 3 study that was terminated before completion, run by VistaGen Therapeutics. The registered enrollment target is 481 participants.
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.
Interventions
- DRUG PH94B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 481 participants |
| Start Date | 2021-10-01 |
| Est. Completion | 2022-09-23 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05030350
The ClinicalTrials.gov registry entry for NCT05030350 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 481 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VistaGen Therapeutics, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PH94B is the first listed.
NCT05030350 reports 0 study locations.
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.
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