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

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06096415
• Other study ID #: ABX-TBI-001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 2023
• Est. completion date: May 2024

Study information

• Verified date: October 2023
• Source: Abalonex, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Brain Edema
• Brain Injuries
• Brain Injuries, Traumatic
• Cerebral Edema
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abalonex, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Glasgow Outcome Scale-Extended (GOS-E)	To demonstrate superiority of ABX-101 vs placebo on the GOS-E at 30 days in participants with TBI	30 days
Secondary	Glasgow Coma Score (GSC) improvement	To demonstrate superiority of ABX-101 vs placebo on the GCS improvement (vs. baseline) at days 3 and 7 in participants with TBI	7 days
Secondary	ICP Maintenance	To demonstrate superiority of ABX-101 vs placebo on the ICP maintenance at 3 days and 7 days in participants with TBI	7 days
Secondary	Midline Shift	To demonstrate superiority of ABX-101 vs placebo on the degree of midline shift as assessed by CT scan at 1 day and 3 days in participants with TBI	3 days
Secondary	Therapeutic Intensity Level	To demonstrate superiority of ABX-101 vs placebo on the Therapeutic Intensity Level over 3 days and over 7 days in participants with TBI	7 days
Secondary	Neuroworsening	To demonstrate superiority of ABX-101 vs placebo on the Neuroworsening at 3 days and 7 days in participants with TBI	7 days
Secondary	Mortality	To demonstrate superiority of ABX-101 vs placebo on the mortality at 3 days, 7 days, 28 days, and 90 days in participants with TBI	180 days
Secondary	Quality of life- (QOLIBRI)	To demonstrate superiority of ABX-101 vs placebo on the Quality of Life after Brain Injury at 90 days in participants with TBI	180 days
Secondary	GFAP Inflammatory Biomarker Analysis	To compare ABX-101 vs placebo on Glial fibrillary acidic protein (GFAP) levels at 1 day, 3 days, and 7 days in participants with TBI. The detection range for GFAP biomarker is 0.31 - 20 ng/ml using ELAB Science GFAP Kit.	7 days
Secondary	Adverse Events	To compare ABX-101 vs placebo in terms of AEs assessed over 7 days of treatment and through the duration of follow-up in participants with TBI	7 days