A Phase 4 interventional study of Placebo and Methylprednisolone (MP) in Traumatic Brain Injury, sponsored by Zhangjiagang First People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Zhangjiagang First People's Hospital · Phase 4, Interventional, and Treatment
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:
Participants will:
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 520 is above the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Zhangjiagang First People's Hospital is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Methylprednisolone (MP)
Drug: Placebo
2 mg/kg diluted in 100 mL of normal saline (maximum dose 160 mg) , IV once daily for 5 days
2 mg/kg diluted in 100 mL of normal saline (maximum dose 160 mg) , IV once daily for 5 days
Distribution of Glasgow Outcome Scale-Extended (GOS-E) scores at 180 days.
Time frame: 180 days
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
CT Measurement of Cerebral Edema Volume
Time frame: From enrollment to 7 days after the end of medication
Mini-Mental State Examination (MMSE)
Time frame: 180 days
EQ-5D-VAS Scores
Time frame: 180 days
Plan to share: 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.
Started Mar 2026 (actual). Primary completion is estimated for Jan 2029, 34 months after the start.
Of 25 phase 4 interventional studies under Brain Injuries, Traumatic, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 148. This study's planned 34 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Methylprednisolone
Zhangjiagang First People's Hospital