Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
1
Countries
1
Sites
1
Post-traumatic brain contusion with edema
Efficacy of dexamethasone in improving the prognosis of patients with TBI, brain contusions and pericontusional edema.
Key facts
- Sponsor
- University Hospital Son Espases
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2026-03-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520887-17-00
- EudraCT number
- 2019-004038-41
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
Efficacy of dexamethasone in improving the prognosis of patients with TBI, brain contusions and pericontusional edema.
Conditions and MedDRA coding
Post-traumatic brain contusion with edema
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- - 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.
- - Age equal to or greater than 18 years and less than 85 years
- -Signature of the informed consent by the patient or his legal representative in case the patient cannot do so.
Exclusion criteria 14
- - Patients with TBI and contusions who have required surgery Evacuation of brain contusion before randomization.
- - Patients with TBI who have required a craniotomy before randomization for any other reason: hematoma evacuation subdural, epidural or sinking fracture.
- - Patients in a 3-point GCS situation with bilateral mydriasis
- - Patients with an extracranial Injury Severity Score greater than 18 points.
- - Patients with associated spinal cord injuries.
- - Patients in whom the use of corticosteroids is contraindicated.
- - Patients who chronically take oral corticosteroids.
- - Patients included in another clinical trial.
- - Known intolerance or hypersensitivity to dexamethasone.
- - Patients with allergy or intolerance to the following excipients contents in dexamethasone/placebo capsules: lactose, starch corn or microcrystalline cellulose.
- - Patients with a history of psychotic disorders.
- - Patients unable to take oral medication due to swallowing problems and in which placing a nasogastric tube.
- - Patient with any systemic condition that, at the discretion of the investigator contraindicates the patient's inclusion in the study.
- Pregnant or breastfeeding patients.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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)”.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10167219 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 16 mg milligram(s)
- Max total dose
- 94 mg milligram(s)
- Max treatment duration
- 12 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 56/1139/93-C
- MA holder
- MERCK SPOL.S.R.O.
- MA country
- Czech Republic
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Hospital Son Espases
2
Total trials
Academic / Non-commercial
- Sponsor organisation
- University Hospital Son Espases
- Address
- Carretera Valldemossa 79
- City
- Palma
- Postcode
- 07120
- Country
- Spain
Scientific contact point
- Organisation
- University Hospital Son Espases
- Contact name
- Juan Perez Barcena
Public contact point
- Organisation
- University Hospital Son Espases
- Contact name
- Juan Perez Barcena
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 1 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol EU CT 2019-004038-41 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment_arramgements-DEXCON | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 1 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF adults | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | J1_Label IMP_SPN_DEXA 1mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | J2_Label IMP_SPN_DEXA 2mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | J3_Label IMP_SPN_DEXA 4mg | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-28 | Spain | Acceptable with conditions 2025-01-30
|
2026-03-26 |