Clinical trial • Not applicable • Neurology

Dexamethasone for Traumatic brain injury (post-traumatic brain contusion with edema)

Not applicable trial of Dexamethasone for Traumatic brain injury (post-traumatic brain contusion with edema).

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Traumatic brain injury (post-traumatic brain contusion with edema)
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
28-01-2025
First CTIS Authorization Date
26-03-2026

Trial design

Randomised, active investigational product: dexamethasone (fortecortin 4 mg tablet). product information lists max daily dose 16 mg, max total dose 94 mg, max treatment period 12 (time unit code 1). comparator/placebo: 10 g celulosa microcristalina 250 g acofarma / cl 0,1 g riboflavina ... (placebo product). no specific dosing schedule detailed in the ctis json.-controlled Not applicable trial across 1 site in Spain.

Randomised
Yes
Comparator
Active investigational product: Dexamethasone (Fortecortin 4 mg tablet). Product information lists max daily dose 16 mg, max total dose 94 mg, max treatment period 12 (time unit code 1). Comparator/placebo: 10 g Celulosa microcristalina 250 g Acofarma / CL 0,1 g Riboflavina ... (placebo product). No specific dosing schedule detailed in the CTIS JSON.
Trial Duration For Participant
30

Eligibility

Recruits 1 Vulnerable population not selected (isVulnerablePopulationSelected: false). Informed consent required: "Signature of the informed consent by the patient or his legal representative in case the patient cannot do so." Subject information and informed consent forms provided for adults (documents L1/L2). No paediatric assent/consent procedures specified..

Pregnancy Exclusion
Pregnant or breastfeeding patients.
Vulnerable Population
Vulnerable population not selected (isVulnerablePopulationSelected: false). Informed consent required: "Signature of the informed consent by the patient or his legal representative in case the patient cannot do so." Subject information and informed consent forms provided for adults (documents L1/L2). No paediatric assent/consent procedures specified.

Inclusion criteria

  • {"criterion_text":"- Patients who have suffered a head injury and who present on computed tomography (CT) one or more bruises brain with pericontusion edema. Those patients will be included with bruises in which it was initially chosen medical, non-surgical treatment.\n- Age equal to or greater than 18 years and less than 85 years\n-Signature of the informed consent by the patient or his legal representative in case the patient cannot do so."}

Exclusion criteria

  • {"criterion_text":"- Patients with TBI and contusions who have required surgery Evacuation of brain contusion before randomization.\n- Patients with TBI who have required a craniotomy before randomization for any other reason: hematoma evacuation subdural, epidural or sinking fracture.\n- Patients in a 3-point GCS situation with bilateral mydriasis\n- Patients with an extracranial Injury Severity Score greater than 18 points.\n- Patients with associated spinal cord injuries.\n- Patients in whom the use of corticosteroids is contraindicated.\n- Patients who chronically take oral corticosteroids.\n- Patients included in another clinical trial.\n- Known intolerance or hypersensitivity to dexamethasone.\n- Patients with allergy or intolerance to the following excipients contents in dexamethasone/placebo capsules: lactose, starch corn or microcrystalline cellulose.\n- Patients with a history of psychotic disorders.\n- Patients unable to take oral medication due to swallowing problems and in which placing a nasogastric tube.\n- Patient with any systemic condition that, at the discretion of the investigator contraindicates the patient's inclusion in the study.\n-Pregnant or breastfeeding patients."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- To evaluate the efficacy of treatment with dexamethasone compared to placebo, measured by the proportion of patients who, one month after the trauma, present good evolution according to the “Extended Glasgow Outcome Scale (GOSE)”.","definition_or_measurement_approach":"Measured by the proportion of patients who, one month after the trauma, present good evolution according to the Extended Glasgow Outcome Scale (GOSE)."}

Recruitment

Recruitment Window Months
72
Consent Approach
Informed consent must be signed by the patient or by the patient's legal representative if the patient cannot provide consent. Subject information and informed consent forms for adults are listed (L1 and L2). No paediatric consent/assent procedures or languages specified in the CTIS JSON.

Geography

Total Number Of Sites
1
Total Number Of Participants
1

Spain

Earliest CTIS Part Ii Submission Date
25-03-2026
Latest Decision Or Authorization Date
26-03-2026
Processing Time Days
1
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
University Hospital Son Espases
Department Name
Critical care unit
Principal Investigator Name
Juan Perez Barcena
Principal Investigator Email
juan.perez@ssib.es
Contact Person Name
Juan Perez Barcena
Contact Person Email
juan.perez@ssib.es
Number Of Participants
1

Sponsor

Primary sponsor

Full Name
University Hospital Son Espases
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Fortecortin 4 mg tablety
Active Substance
Dexamethasone
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Authorised (marketing authorisation: 56/1139/93-C; authorisation country code: CZ)
Starting Dose
4 mg (tablet strength)
Maximum Dose
16 mg (max daily dose)
Investigational Product Name
10 g Celulosa microcristalina 250 g Acofarma CL 0,1 g Riboflavina (vit. B2) (vit. B2) 250 g Acofarma 200 cáps Cápsulas Nº4 blancas-verdes 1000 Ud Acofarma
Modality
Other
Authorisation Status
Not authorised / no MA number provided in CTIS record

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