A Randomised, Double-blind, Placebo-controlled Phase 2a Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONP-002 in Adults With Mild Traumatic Brain Injury
← catalyst calendarSponsored by Oragenics, Inc. (industry) · OGEN — their whole pipeline →.
Phase
Phase 2
Status
Not yet recruiting
Study type
Interventional
Design
Na · Quadruple · Treatment
Enrollment
40estimated
Sites
1
Country
Australia
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-06-01 | estimated | When the study began enrolling |
| Primary completion | 2026-01-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-03-31 | estimated | The whole study's end, after follow-up |
| First posted | 2025-03-11 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-03-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Mild Traumatic Brain Injury, Concussion
Intervention
- Drug: Neurosteroid enantiomer
Primary outcome
what the primary-completion date above is the date OFPatient symptom reporting
measured Days 2, 5, 10 and 30 post-injurt
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