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Updated: Aug 5, 2026

Controlled Cortical Impact Model for Traumatic Brain Injury
Published on: August 5, 2014
Current Clinical Trials in Traumatic Brain Injury
Zubair Ahmed1,2,3
1Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.
Abstract:
Traumatic brain injury (TBI) is one of the leading causes of morbidity, disability and mortality across all age groups globally. Currently, only palliative treatments exist, but these are suboptimal and do little to combat the progressive damage to the brain that occurs after a TBI. However, multiple experimental treatments are currently available that target the primary and secondary biochemical and cellular changes that occur after a TBI. Some of these drugs have progressed to clinical trials and are currently being evaluated for their therapeutic benefits in TBI patients. The aim of this study was to identify which drugs are currently being evaluated in clinical trials for TBI. A search of ClinicalTrials.gov was performed on 3 December 2021 and all clinical trials that mentioned "TBI" OR "traumatic brain injury" AND "drug" were searched, revealing 362 registered trials. Of the trials, 46 were excluded due to the drug not being mentioned, leaving 138 that were completed and 116 that were withdrawn. Although the studies included 267,298 TBI patients, the average number of patients per study was 865 with a range of 5-200,000. Of the completed studies, 125 different drugs were tested in TBI patients but only 7 drugs were used in more than three studies, including amantadine, botulinum toxin A and tranexamic acid (TXA). However, previous clinical studies using these seven drugs showed variable results. The current study concludes that clinical trials in TBI have to be carefully conducted so as to reduce variability across studies, since the severity of TBI and timing of therapeutic interventions were key aspects of trial success.
Insights
Clinical trials for traumatic brain injury (TBI) are evaluating many drugs, but few are widely studied. Careful trial design is crucial for success in TBI treatment research.
Area of Science:
- Neuroscience
- Clinical Pharmacology
- Trauma Surgery
Background:
- Traumatic brain injury (TBI) is a major global health concern causing significant morbidity and mortality.
- Current TBI treatments are largely palliative and fail to address progressive brain damage.
- Experimental therapies targeting TBI's biochemical and cellular consequences are under development.
Purpose of the Study:
- To identify drugs currently undergoing clinical evaluation for TBI treatment.
- To analyze the landscape of drug-related clinical trials for traumatic brain injury.
Main Methods:
- A comprehensive search of ClinicalTrials.gov was conducted on December 3, 2021.
- Trials were identified using keywords "TBI" OR "traumatic brain injury" AND "drug".
- Data on registered trials, patient numbers, and drugs tested were extracted and analyzed.
Main Results:
- 362 TBI drug trials were initially identified; 138 were completed and 116 withdrawn.
- 125 different drugs were tested in TBI patients across completed studies.
- Only 7 drugs, including amantadine, botulinum toxin A, and tranexamic acid (TXA), were used in over three studies, with variable results.
Conclusions:
- The clinical trial landscape for TBI reveals a broad but fragmented approach to drug development.
- Limited re-use of specific drugs suggests variability in trial outcomes and efficacy.
- Future TBI clinical trials must prioritize rigorous design, considering TBI severity and intervention timing to reduce variability and enhance success.
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