Recent Updates
Recently added Catalysts

ONP-002

Phase 2

Mild Traumatic Brain Injury, Concussion | Small molecule | Neurology |Oragenics Inc.|Last Updated: Mar 11, 2025

Target and mechanism

ModalitySmall molecule

Also known as Neurosteroid enantiomer

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

Double-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

ONP-002 · 1 trial · 1 indication

Phase 2 1
NCT06870240A 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 InjuryMild Traumatic Brain Injury, Concussion
NOT YET_RECRUITING40 Analytics
PHASE2NOT YET_RECRUITING
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
Mild Traumatic Brain Injury, Concussion
NCT0687024040
Unlock trial analytics

Study Endpoints

Primary Endpoints

Patient symptom reporting
Days 2, 5, 10 and 30 post-injurt

Neurological questionnaires for patient symptoms including Rivermead

Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
92mg of Hydroxy-propyl beta-cyclodextrin as a spray-dried powderPLACEBO_COMPARATORThe placebo is 92mg of Hydroxy-propyl beta-cyclodextrin as a spray-dried powder
ONP-002 treatmentACTIVE_COMPARATORONP-002 is 8mg API and 92 Hydroxy-propyl beta-cyclodextrin as a spray-dried powder

Interventions

NameTypeDescription
Neurosteroid enantiomerDRUGA non-natural synthetic neurosteroid enantiomer considered a new chemical entity
Unlock Study Design Details

Eligibility Criteria

Age Range18 Months to 60 Months
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:Australia
Unlock Eligibility Criteria