Clinical trial NCT06096415: Safety and Efficacy of ABX-101 in Participants Aged 18 to 50 Years of Age With Moderate to Severe Traumatic Brain Injury
Official title: A Parallel Group Treatment, Phase 2A, Double-blind, 3-arm Study to Investigate Safety and Efficacy of ABX-101 Compared With Placebo in Male and Female Participants, Aged 18 to 50 Years, With Moderate-to-severe Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Traumatic Brain Injury
Cerebral Edema
Keywords: Traumatic brain injury
Lead sponsor: Abalonex, LLC
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 with moderate to severe TBI.

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 study.

Number of Participants:

A maximum of 45 participants will be enrolled into the study and randomized to each treatment arm in a ratio of 1:1:1. i.e., fifteen participants per arm.

Study Arms and Duration:

Participants will be screened, enrolled and receive the assigned treatment within 12 hours of the primary TBI insult. Enrolled participants will be stratified 1:1 (in each arm) by GCS score (GCS 4-8 in one group and GCS 9 - 12 in the other). The treatment period, which involves 6 hourly, i.e., quarter in die (QID), ABX-101 (1 mg OR 2 mg) intramuscular injections, is seven days. Enrolled participant will continue with the in-hospital standard of care, as decided by the external treating physician, and will be followed up by the study team on days 30 and days 180. The ABX-101 1 mg and 2 mg arm will be enrolled simultaneously.

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)

Primary outcomes:
measure: Glasgow Outcome Scale-Extended (GOS-E)
timeFrame: 180 days
Secondary outcomes:
measure: Glasgow Outcome Scale-Extended (GOS-E)
timeFrame: 30 days
measure: Glasgow Coma Score (GSC) improvement
timeFrame: 7 days
measure: ICP Maintenance
timeFrame: 7 days
measure: Midline Shift
timeFrame: 3 days
measure: Therapeutic Intensity Level
timeFrame: 7 days
measure: Neuroworsening
timeFrame: 7 days
measure: Mortality
timeFrame: 180 days
measure: Quality of life- (QOLIBRI)
timeFrame: 180 days
measure: GFAP Inflammatory Biomarker Analysis
timeFrame: 7 days
measure: Adverse Events
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
References: