Safety and Efficacy of ABX-101 in Participants Aged 18 to 50 Years of Age With Moderate to Severe Traumatic Brain Injury

Launched by ABALONEX, LLC · Oct 20, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called ABX-101 to see if it can help improve recovery for adults aged 18 to 50 who have suffered moderate to severe traumatic brain injuries (TBI). The study aims to compare how well ABX-101 works versus a placebo (which is a treatment that looks like the real drug but has no active ingredients) by measuring recovery using a tool called the Glasgow Outcome Scale Extended (GOS-E). Participants will need to have their injury occur within 12 hours before receiving the treatment and must be expected to survive for at least 24 hours after being admitted to the hospital.

To be eligible for this trial, participants must give consent (or have a legal guardian provide consent) and have a specific type of brain injury that requires close monitoring. They should also have a Glasgow Coma Score (GCS) between 4 and 12, indicating varying levels of consciousness. However, certain conditions, such as major brain damage from previous injuries or other serious health issues, may exclude someone from participating. While the study is not yet recruiting, those who qualify will receive either ABX-101 or a placebo, and their recovery will be closely monitored during the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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)