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Prevention study for Seizures
Official title Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)
ClinicalTrials.gov ID: NCT07072624
What this study is testing
What is Phenytoin?
Phenytoin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for seizures.
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
- Rationale/gaps in existing knowledge: The prophylaxis for post-traumatic seizures (PTS) remains controversial due to a lack of class I evidence. Investigators plan to conduct a high-quality, prospective, multicentric, randomized study regarding seizure prophylaxis in traumatic brain injury (TBI) with phenytoin, levetiracetam, and the placebo in three respective treatment groups, along with the effect of drug polymorphism on seizure occurrence.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 70
You may be able to join if
- Patients of severe blunt TBI with GCS score less than 10.
- Patients with GCS of more than 10 in the presence of computed tomographic imaging findings consistent with brain injury: subarachnoid hemorrhage...
- Patients with penetrating injury.
You likely can't join if
- Females of childbearing age with urine pregnancy test positive.
- Devastating brain injury with expected or confirmed brain death within 48 hours of hospital admission,
- Prehospital use of anticonvulsants
- Development of seizures before enrolment.
The study team makes the final eligibility decision.
Where it's taking place
- Chandigarh, Punjab, India
- Jodhpur, Rajasthan, India
- Lucknow, Uttar Pradesh, India
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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandigarh, Punjab, India; Jodhpur, Rajasthan, India; Lucknow, Uttar Pradesh, India. 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.