Status:
UNKNOWN
Safety and Efficacy of ABX-101 in Participants Aged 18 to 50 Years of Age With Moderate to Severe Traumatic Brain Injury
Lead Sponsor:
Abalonex, LLC
Conditions:
Traumatic Brain Injury
Cerebral Edema
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate the clinical improvement measured by the Glasgow Outcome Scale Extended (GOS-E) with ABX-101 compared with Placebo intramuscular injection in participants w...
Detailed Description
Study details include: * The study duration will be up to 180 days per participant. * The treatment duration will be up to 7 days. * The visits post-treatment will be on day 30 and day 180 of the stu...
Eligibility Criteria
Inclusion
- Written informed consent from patient, patient's legal guardian or legal representative, or deferred consent procedure, according to local requirements
- 18 - 50 years of age, inclusive
- Expected to survive more than 24 hours after admission
- Clearly defined time of injury no more than 12 hours before administration of study drug/placebo
- o Subjects stratified 1:1 (in each arm) by treatment administered 0-12 hrs
- TBI with Glasgow Coma Score (GCS) 4-12 requiring intracranial pressure (ICP) monitoring according to the assessment of the treating physician
- o Subjects stratified 1:1 (in each arm) by GCS 4-8 and GCS 9-12
- Catheter placement (intraventricular or intraparenchymal, only) for monitoring and management of increased ICP
- \[Brain computed tomography (CT) showing intracranial parenchymal abnormality and hemodynamically stable\]
Exclusion
- Penetrating head injury (e.g. missile, stab wound)
- Concurrent, but not pre-existing, spinal cord injury
- Not expected to survive more than 24 hours after admission
- Pregnant, or a positive pregnancy test
- Coma due to an exclusive epidural hematoma (lucid interval and absence of structural brain damage on CT scan)
- Patient pupils are unresponsive (dilation) in both eyes
- The subject has a neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors.
- Coma suspected to be primarily due to other causes than head injury (e.g. drug overdose intoxication, drowning/near drowning
- Known or CT scan evidence of pre-existing major cerebral damage
- Any severe concomitant condition (cancer; hematologic, renal, hepatic, coronary disease; major psychiatric disorder; alcohol or drug abuse), that can be ascertained at admission
- Known to have received an experimental drug within 4 weeks prior to current injury
- Patients who cannot be monitored with regard to their recovery (GOS-E and QOLIBRI)
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06096415
Start Date
December 1 2023
End Date
May 1 2024
Last Update
October 23 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.