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

NCT06096415 | Unknown Phase 2

• 1 other identifier: ABX-TBI-001
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Traumatic Brain Injury; Cerebral Edema

Keywords

Traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• Glasgow Outcome Scale-Extended (GOS-E)

  To demonstrate superiority of ABX-101 vs placebo on the Glasgow Outcome Scale-Extended (GOS-E) at 90-days in participants with TBI

  180 days

Secondary Outcomes (10)

• Glasgow Outcome Scale-Extended (GOS-E)

  30 days

• Glasgow Coma Score (GSC) improvement

  7 days

• ICP Maintenance

  7 days

• Midline Shift

  3 days

• Therapeutic Intensity Level

  7 days

Study Arms (3)

Experimental: ABX-101 1mg

EXPERIMENTAL

Participants will be screened, enrolled and receive the assigned treatment within 12 hours of the primary TBI insult (or estimated less than 12 hours if the exact time is unknown). 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.

Drug: ABX-101 1mg; Drug: ABX-101 2mg

Experimental: ABX-101 2mg

EXPERIMENTAL

Participants will be screened, enrolled and receive the assigned treatment within 12 hours of the primary TBI insult (or estimated less than 12 hours if the exact time is unknown). 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.

Drug: ABX-101 1mg; Drug: ABX-101 2mg

Placebo Comparator: Saline

PLACEBO COMPARATOR

Placebo to the ABX-101 will be administered to patients.

Drug: ABX-101 1mg; Drug: ABX-101 2mg

Interventions

ABX-101 1mg DRUG

ABX-101 1mg will be provided to patients stratified 1:1 by GCS scoring (GCS 4-8; GCS 9-12)

Experimental: ABX-101 1mg; Experimental: ABX-101 2mg; Placebo Comparator: Saline

ABX-101 2mg DRUG

ABX-101 2mg will be provided to patients stratified 1:1 by GCS scoring (GCS 4-8; GCS 9-12)

Experimental: ABX-101 1mg; Experimental: ABX-101 2mg; Placebo Comparator: Saline

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent from patient, patient's legal guardian or legal representative, or deferred consent procedure, according to local requirements
• 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
• \[Brain computed tomography (CT) showing intracranial parenchymal abnormality and hemodynamically stable\]

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abalonex, LLC: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Edema

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: October 23, 2023
• Study Start: December 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10