Traumatic Brain InjuryPhase 2NCT06096415
Safety and Efficacy of ABX-101 in Participants Aged 18 to 50 Years of Age With Moderate to Severe Traumatic Brain Injury
A Phase 2 study testing ABX-101 1mg and ABX-101 2mg in people with Traumatic Brain Injury and Cerebral Edema, run by Abalonex, LLC.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Traumatic Brain Injury, Cerebral Edema
- What is being tested?
- ABX-101 1mg and ABX-101 2mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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]
Who cannot join
- 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
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- 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)
About this study
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
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.
Read the 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.
- Conditions
- Traumatic Brain Injury, Cerebral Edema
- Being tested
- ABX-101 1mg, ABX-101 2mg
- Keywords
- Traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic, Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABX-101 1mgDrug
ABX-101 1mg will be provided to patients stratified 1:1 by GCS scoring (GCS 4-8; GCS 9-12)
ABX-101 2mgDrug
ABX-101 2mg will be provided to patients stratified 1:1 by GCS scoring (GCS 4-8; GCS 9-12)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: ABX-101 1mg; Drug: ABX-101 2mg |
| Placebo Comparator: Saline | Placebo comparator | Placebo to the ABX-101 will be administered to patients. Receives: Drug: ABX-101 1mg; Drug: ABX-101 2mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 180 days
Secondary outcomes (10)
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
Measured: 30 days
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
Measured: 7 days
ICP Maintenance
To demonstrate superiority of ABX-101 vs placebo on the ICP maintenance at 3 days and 7 days in participants with TBI
Measured: 7 days
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
Measured: 3 days
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
Measured: 7 days
Neuroworsening
To demonstrate superiority of ABX-101 vs placebo on the Neuroworsening at 3 days and 7 days in participants with TBI
Measured: 7 days
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
Measured: 180 days
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
Measured: 180 days
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.
Measured: 7 days
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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study startDec 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abalonex, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096415
- Sponsor's protocol ID
- ABX-TBI-001
- Status last verified
- Oct 2023
- First submitted
- 2 May 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06096415
- Acronym / sponsor ID
- ABX-TBI-001
- Conditions
- Traumatic Brain Injury, Cerebral Edema
- Keywords
- Traumatic brain injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Abalonex, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: ABX-101 1mg | Experimental | Drug: ABX-101 1mg, Drug: ABX-101 2mgParticipants 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. |
| Experimental: ABX-101 2mg | Experimental | Drug: ABX-101 1mg, Drug: ABX-101 2mgParticipants 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. |
| Placebo Comparator: Saline | Placebo comparator | Drug: ABX-101 1mg, Drug: ABX-101 2mgPlacebo to the ABX-101 will be administered to patients. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABX-101 1mgABX-101 1mg will be provided to patients stratified 1:1 by GCS scoring (GCS 4-8; GCS 9-12) | Drug | Experimental: ABX-101 1mg, Experimental: ABX-101 2mg, Placebo Comparator: Saline |
| ABX-101 2mgABX-101 2mg will be provided to patients stratified 1:1 by GCS scoring (GCS 4-8; GCS 9-12) | Drug | Experimental: ABX-101 1mg, Experimental: ABX-101 2mg, Placebo Comparator: Saline |
Primary outcome
Glasgow Outcome Scale-Extended (GOS-E)
Time frame: 180 days
To demonstrate superiority of ABX-101 vs placebo on the Glasgow Outcome Scale-Extended (GOS-E) at 90-days in participants with TBI
10 secondary outcomes
Glasgow Outcome Scale-Extended (GOS-E)
Time frame: 30 days
Glasgow Coma Score (GSC) improvement
Time frame: 7 days
ICP Maintenance
Time frame: 7 days
Midline Shift
Time frame: 3 days
Therapeutic Intensity Level
Time frame: 7 days
Neuroworsening
Time frame: 7 days
Mortality
Time frame: 180 days
Quality of life- (QOLIBRI)
Time frame: 180 days
GFAP Inflammatory Biomarker Analysis
Time frame: 7 days
Adverse Events
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABX-101 1mg and ABX-101 2mg in people with Traumatic Brain Injury and Cerebral Edema, run by Abalonex, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Scale-Extended (GOS-E) (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.