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Prevention study for Brain Injury Traumatic Moderate
Official title Biperiden Trial for Epilepsy Prevention
ClinicalTrials.gov ID: NCT04945213
What this study is testing
What is Biperiden?
Biperiden is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for brain injury traumatic moderate.
Also referred to as Akineton.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- One of the most important neurological consequences following Traumatic Brain Injury (TBI) is the development of post traumatic epilepsy (PTE). Nevertheless, there is still no effective therapeutic intervention to reduce the occurrence of PTE.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Given informed consent
- 18 - 75 years of age
- GCS between 6 and 12 at hospital admission. GCS between 3 and 5 at hospital admission can be enrolled if patient was sedated at the accident scene...
- Moderate or severe acute traumatic brain injury
- All genders
You likely can't join if
- Previous use of biperiden
- History of epilepsy (confirmed by patient chart)
- History of seizures or use of antiepileptic medication
- Pregnancy
- Participation in another clinical trial at the time of randomization
- History of neoplasia, neurodegenerative diseases; history of stroke, cognitive impairment, benign prostatic hyperplasia, atrioventricular block or...
See the full eligibility criteria
- Given informed consent
- 18 - 75 years of age
- GCS between 6 and 12 at hospital admission. GCS between 3 and 5 at hospital admission can be enrolled if patient was sedated at the accident scene with previous GCS between 6 and 15.
- Moderate or severe acute traumatic brain injury
- All genders
- Brain CT scan with signs of of acute intraparenchymal hemorrhage and/or contusion
- Able to receive the first dose of treatment or placebo within 18 hours of brain injury,
- Previous use of biperiden
- History of epilepsy (confirmed by patient chart)
- History of seizures or use of antiepileptic medication
- Pregnancy
- Participation in another clinical trial at the time of randomization
- History of neoplasia, neurodegenerative diseases; history of stroke, cognitive impairment, benign prostatic hyperplasia, atrioventricular block or any other cardiac arrhythmia, or glaucoma megacolon or mechanical...
- Homeless patient
The study team makes the final eligibility decision.
Where it's taking place
- Fortaleza, Ceará, Brazil
- Sobral, Ceará, Brazil
- Vitória, Espírito Santo, Brazil
- Salvador, Estado de Bahia, Brazil
- Campo Grande, Mato Grosso do Sul, Brazil
- Passo Fundo, Rio Grande do Sul, Brazil
- Ribeirão Preto, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- São Paulo, Brazil
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fortaleza, Ceará, Brazil; Sobral, Ceará, Brazil; Vitória, Espírito Santo, Brazil; Salvador, Estado de Bahia, Brazil; Campo Grande, Mato Grosso do Sul, Brazil; Passo Fundo, Rio Grande do Sul, Brazil and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.