Traumatic Brain InjuryPhase 4ESM-TBINCT07180277
Methylprednisolone for Moderate to Severe Traumatic Brain Injury
A Phase 4 study testing Methylprednisolone (MP) in people with Traumatic Brain Injury, run by Zhangjiagang First People's Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if standard-dose methylprednisolone sodium succinate can improve neurological recovery and safety in adults with moderate to severe traumatic brain injury (TBI). The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Methylprednisolone (MP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 520 participants
- Where
- 1 siteChina
- Study dates
- 29 Mar 2026to 31 Jul 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age18-65 years.
- Patients with moderate-to-severe traumatic brain injury whose Glasgow Coma Scale (GCS) score at admission is4-12.
- Study drug must be initiated within12 hours after injury.
- Imaging (CT) demonstrates cerebral contusion, or cerebral contusion with intracerebral hematoma.
- Written informed consent obtained from the subject or legally authorized representative.
Who cannot join
- Known hypersensitivity to corticosteroids or any contraindication to their use.
- History of diabetes mellitus requiring pharmacological treatment, or capillary blood glucose<2.8 mmol/L or >22.2 mmol/L.
- Shock at admission (systolic blood pressure<90 mmHg for more than30 minutes).
- Pregnant or lactating women.
- Patients with systemic infectious diseases.
- Patients with a confirmed diagnosis of peptic ulcer.
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- Patients with a confirmed diagnosis of systemic autoimmune diseases.
- Participation in another clinical trial within the past3 months.
- Any condition that, in the investigator's opinion, renders the patient unsuitable for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhangjiagang First People's Hospital
Suzhou, Jiangsu, 215600
Xiaobo Qian, +86 136167248318, 776730288@qq.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Methylprednisolone Sodium Succinate Injection in Patients With Moderate to Severe Traumatic Brain Injury
The goal of this clinical trial is to learn if standard-dose methylprednisolone sodium succinate can improve neurological recovery and safety in adults with moderate to severe traumatic brain injury (TBI). The main questions it aims to answer are:
- Does adding a 5-day course of methylprednisolone improve overall long-term neurological outcome compared with placebo?
- Does methylprednisolone reduce 6-month mortality or increase the proportion of patients with good neurological recovery?
- What medical problems do participants experience when receiving methylprednisolone? Researchers will compare methylprednisolone sodium succinate (2 mg/kg/day intravenously for 5 days) with a matching placebo to see if the steroid improves outcomes beyond standard TBI care.
Read more
Participants will:
- Receive either methylprednisolone or placebo once daily for 5 days, added to guideline-directed standard care.
- Undergo CT scans and neuro-examinations during hospitalization.
- Return for follow-up visits at 1 month and 6 months after injury for neurological assessments, safety checks, and questionnaires.
- Conditions
- Traumatic Brain Injury
- Being tested
- Placebo, Methylprednisolone (MP)
- Keywords
- Methylprednisolone, Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
2 mg/kg diluted in 100 mL of normal saline (maximum dose 160 mg) , IV once daily for 5 days
Methylprednisolone (MP)Drug
2 mg/kg diluted in 100 mL of normal saline (maximum dose 160 mg) , IV once daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| methylprednisolone | Experimental | Not described Receives: Drug: Methylprednisolone (MP) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of Glasgow Outcome Scale-Extended (GOS-E) scores at 180 days.
Measured: 180 days
Secondary outcomes (3)
All-cause mortality
Measured: 180 days
Proportion of patients with good neurological outcome (GOS-E 5-8)
Measured: 180 days
Incidence of adverse events after treatment
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start29 Mar 2026
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhangjiagang First People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Gao, Zhangjiagang First People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180277
- Sponsor's protocol ID
- ZJGSY2025001
- Acronym
- ESM-TBI
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical restrictions. The study protocol and statistical analysis plan are available upon reasonable request from the corresponding author.
Publications
Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition. Neurosurgery. 2017 Jan 1;80(1):6-15. doi: 10.1227/NEU.0000000000001432.
PubMed 27654000Roberts I, Yates D, Sandercock P, Farrell B, Wasserberg J, Lomas G, Cottingham R, Svoboda P, Brayley N, Mazairac G, Laloe V, Munoz-Sanchez A, Arango M, Hartzenberg B, Khamis H, Yutthakasemsunt S, Komolafe E, Olldashi F, Yadav Y, Murillo-Cabezas F, Shakur H, Edwards P; CRASH trial collaborators. Effect of intravenous corticosteroids on death within 14 days in 10008 adults with clinically significant head injury (MRC CRASH trial): randomised placebo-controlled trial. Lancet. 2004 Oct 9-15;364(9442):1321-8. doi: 10.1016/S0140-6736(04)17188-2.
PubMed 15474134He C, Wang Y, Gong W, Zhang S. Targeted Delivery of Acid-Responsive Rutin Nanoparticles Based on Aldehyde Adsorption for the Treatment of Spinal Cord Injury in Rats. ACS Biomater Sci Eng. 2025 Apr 14;11(4):2192-2202. doi: 10.1021/acsbiomaterials.5c00038. Epub 2025 Apr 1.
PubMed 40167167Chen X, Chai Y, Wang SB, Wang JC, Yue SY, Jiang RC, Zhang JN. Risk factors for corticosteroid insufficiency during the sub-acute phase of acute traumatic brain injury. Neural Regen Res. 2020 Jul;15(7):1259-1265. doi: 10.4103/1673-5374.272611.
PubMed 31960811Zhang B, Bai M, Xu X, Yang M, Niu F, Gao F, Liu B. Corticosteroid receptor rebalancing alleviates critical illness-related corticosteroid insufficiency after traumatic brain injury by promoting paraventricular nuclear cell survival via Akt/CREB/BDNF signaling. J Neuroinflammation. 2020 Oct 25;17(1):318. doi: 10.1186/s12974-020-02000-2.
PubMed 33100225Liu Z, Yang Y, He L, Pang M, Luo C, Liu B, Rong L. High-dose methylprednisolone for acute traumatic spinal cord injury: A meta-analysis. Neurology. 2019 Aug 27;93(9):e841-e850. doi: 10.1212/WNL.0000000000007998. Epub 2019 Jul 29.
PubMed 31358617Zhang Y, Xiao S, Zhu L, Gan X, Huang Y, Dan F, Chen J, Zhou R, Tang W, Liu J, Liu Z. Effect of Low-dose Methylprednisolone in Promoting Neurological Function Recovery After Spinal Cord Injury: Clinical and Animal Studies. Spine (Phila Pa 1976). 2025 Jul 15;50(14):965-974. doi: 10.1097/BRS.0000000000005269. Epub 2025 Jan 29.
PubMed 39876698Zheng C, Li R, Shen C, Guo F, Fan D, Yang L, Zhang L, Chen A, Chen Y, Chen D, Zi W, Guo C, Nguyen TN, Albers GW, Campbell BCV, Qiu Z, Hu Z. Methylprednisolone as Adjunct to Thrombectomy for Acute Intracranial Internal Carotid Artery Occlusion Stroke: Post Hoc Secondary Analysis of the MARVEL Randomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2459945. doi: 10.1001/jamanetworkopen.2024.59945.
PubMed 39964685Wang B, Zhang Q, Liu C, Chen X. Counteracting immunodepression by extracellular matrix hydrogel to promote brain tissue remodeling and neurological function recovery after traumatic brain injury. Biomaterials. 2025 Jul;318:123181. doi: 10.1016/j.biomaterials.2025.123181. Epub 2025 Feb 8.
PubMed 39970603
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Methylprednisolone Sodium Succinate Injection in Patients With Moderate to Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT07180277
- Acronym / sponsor ID
- ESM-TBI / ZJGSY2025001
- Conditions
- Traumatic Brain Injury
- Keywords
- Methylprednisolone, Traumatic Brain Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Zhangjiagang First People's HospitalUniversity, hospital or other
- Study start
- 29 Mar 2026 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 18 Sep 2025 (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 goal of this clinical trial is to learn if standard-dose methylprednisolone sodium succinate can improve neurological recovery and safety in adults with moderate to severe traumatic brain injury (TBI). The main questions it aims to answer are:
- Does adding a 5-day course of methylprednisolone improve overall long-term neurological outcome compared with placebo?
- Does methylprednisolone reduce 6-month mortality or increase the proportion of patients with good neurological recovery?
- What medical problems do participants experience when receiving methylprednisolone? Researchers will compare methylprednisolone sodium succinate (2 mg/kg/day intravenously for 5 days) with a matching placebo to see if the steroid improves outcomes beyond standard TBI care.
Participants will:
- Receive either methylprednisolone or placebo once daily for 5 days, added to guideline-directed standard care.
- Undergo CT scans and neuro-examinations during hospitalization.
- Return for follow-up visits at 1 month and 6 months after injury for neurological assessments, safety checks, and questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methylprednisolone | Experimental | Drug: Methylprednisolone (MP) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age18-65 years.
- Patients with moderate-to-severe traumatic brain injury whose Glasgow Coma Scale (GCS) score at admission is4-12.
- Study drug must be initiated within12 hours after injury.
- Imaging (CT) demonstrates cerebral contusion, or cerebral contusion with intracerebral hematoma.
- Written informed consent obtained from the subject or legally authorized representative.
Key exclusion criteria (9 listed)
- Known hypersensitivity to corticosteroids or any contraindication to their use.
- History of diabetes mellitus requiring pharmacological treatment, or capillary blood glucose<2.8 mmol/L or >22.2 mmol/L.
- Shock at admission (systolic blood pressure<90 mmHg for more than30 minutes).
- Pregnant or lactating women.
- Patients with systemic infectious diseases.
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 |
|---|---|---|
| Placebo2 mg/kg diluted in 100 mL of normal saline (maximum dose 160 mg) , IV once daily for 5 days | Drug | Placebo |
| Methylprednisolone (MP)2 mg/kg diluted in 100 mL of normal saline (maximum dose 160 mg) , IV once daily for 5 days | Drug | methylprednisolone |
Primary outcome
Distribution of Glasgow Outcome Scale-Extended (GOS-E) scores at 180 days.
Time frame: 180 days
3 secondary outcomes
All-cause mortality
Time frame: 180 days
Proportion of patients with good neurological outcome (GOS-E 5-8)
Time frame: 180 days
Incidence of adverse events after treatment
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 27654000Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition. Neurosurgery. 2017 Jan 1;80(1):6-15. doi: 10.1227/NEU.0000000000001432.
- Background: PubMed 15474134Roberts I, Yates D, Sandercock P, Farrell B, Wasserberg J, Lomas G, Cottingham R, Svoboda P, Brayley N, Mazairac G, Laloe V, Munoz-Sanchez A, Arango M, Hartzenberg B, Khamis H, Yutthakasemsunt S, Komolafe E, Olldashi F, Yadav Y, Murillo-Cabezas F, Shakur H, Edwards P; CRASH trial collaborators. Effect of intravenous corticosteroids on death within 14 days in 10008 adults with clinically significant head injury (MRC CRASH trial): randomised placebo-controlled trial. Lancet. 2004 Oct 9-15;364(9442):1321-8. doi: 10.1016/S0140-6736(04)17188-2.
- Background: PubMed 40167167He C, Wang Y, Gong W, Zhang S. Targeted Delivery of Acid-Responsive Rutin Nanoparticles Based on Aldehyde Adsorption for the Treatment of Spinal Cord Injury in Rats. ACS Biomater Sci Eng. 2025 Apr 14;11(4):2192-2202. doi: 10.1021/acsbiomaterials.5c00038. Epub 2025 Apr 1.
- Background: PubMed 31960811Chen X, Chai Y, Wang SB, Wang JC, Yue SY, Jiang RC, Zhang JN. Risk factors for corticosteroid insufficiency during the sub-acute phase of acute traumatic brain injury. Neural Regen Res. 2020 Jul;15(7):1259-1265. doi: 10.4103/1673-5374.272611.
- Background: PubMed 33100225Zhang B, Bai M, Xu X, Yang M, Niu F, Gao F, Liu B. Corticosteroid receptor rebalancing alleviates critical illness-related corticosteroid insufficiency after traumatic brain injury by promoting paraventricular nuclear cell survival via Akt/CREB/BDNF signaling. J Neuroinflammation. 2020 Oct 25;17(1):318. doi: 10.1186/s12974-020-02000-2.
- Background: PubMed 31358617Liu Z, Yang Y, He L, Pang M, Luo C, Liu B, Rong L. High-dose methylprednisolone for acute traumatic spinal cord injury: A meta-analysis. Neurology. 2019 Aug 27;93(9):e841-e850. doi: 10.1212/WNL.0000000000007998. Epub 2019 Jul 29.
- Background: PubMed 39876698Zhang Y, Xiao S, Zhu L, Gan X, Huang Y, Dan F, Chen J, Zhou R, Tang W, Liu J, Liu Z. Effect of Low-dose Methylprednisolone in Promoting Neurological Function Recovery After Spinal Cord Injury: Clinical and Animal Studies. Spine (Phila Pa 1976). 2025 Jul 15;50(14):965-974. doi: 10.1097/BRS.0000000000005269. Epub 2025 Jan 29.
- Background: PubMed 39964685Zheng C, Li R, Shen C, Guo F, Fan D, Yang L, Zhang L, Chen A, Chen Y, Chen D, Zi W, Guo C, Nguyen TN, Albers GW, Campbell BCV, Qiu Z, Hu Z. Methylprednisolone as Adjunct to Thrombectomy for Acute Intracranial Internal Carotid Artery Occlusion Stroke: Post Hoc Secondary Analysis of the MARVEL Randomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2459945. doi: 10.1001/jamanetworkopen.2024.59945.
- Background: PubMed 39970603Wang B, Zhang Q, Liu C, Chen X. Counteracting immunodepression by extracellular matrix hydrogel to promote brain tissue remodeling and neurological function recovery after traumatic brain injury. Biomaterials. 2025 Jul;318:123181. doi: 10.1016/j.biomaterials.2025.123181. Epub 2025 Feb 8.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical restrictions. The study protocol and statistical analysis plan are available upon reasonable request from the corresponding author.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone (MP) in people with Traumatic Brain Injury, run by Zhangjiagang First People's Hospital at 1 site in China.
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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaobo Qian (+86 13616248318, 776730288@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of Glasgow Outcome Scale-Extended (GOS-E) scores at 180 days. (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07180277, which also lists 9 linked publications.
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 22 Sep 2026.