Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06870240 | 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 | PHASE2 | NOT YET_RECRUITING | 40 | — | — | Jun 1, 2025 | Mar 31, 2026 | Mar 11, 2025 | 1 | Australia |
Neurological questionnaires for patient symptoms including Rivermead
| Arm | Type | Description |
|---|---|---|
| 92mg of Hydroxy-propyl beta-cyclodextrin as a spray-dried powder | PLACEBO_COMPARATOR | The placebo is 92mg of Hydroxy-propyl beta-cyclodextrin as a spray-dried powder |
| ONP-002 treatment | ACTIVE_COMPARATOR | ONP-002 is 8mg API and 92 Hydroxy-propyl beta-cyclodextrin as a spray-dried powder |
| Name | Type | Description |
|---|---|---|
| Neurosteroid enantiomer | DRUG | A non-natural synthetic neurosteroid enantiomer considered a new chemical entity |
7.2.1 Inclusion Criteria Participants with suspected concussion presenting to the emergency department will be included in the study only if they satisfy all the following criteria: 1. Participant or legal representative is willing and capable of giving written informed consent before any study-re...