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

• Status: Not yet recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

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 with moderate to severe TBI.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abalonex, LLC

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)