What is this study trying to find out about seizures in traumatic brain injury?

This study is investigating how well phenytoin and levetiracetam prevent early seizures after traumatic brain injury. Researchers want to understand seizure occurrence, treatment safety, cost-effectiveness, and the role of genetics in drug response. The All India Institute of Medical Sciences, Jodhpur, leads this important research to improve seizure prevention in TBI patients.

Who may be eligible for this traumatic brain injury clinical trial?

Adults aged 18 to 70 years with severe blunt or penetrating traumatic brain injury may be eligible. Participants should meet specific brain injury criteria and not have used anticonvulsants before hospital admission. Both males and females can participate, but pregnant women are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this traumatic brain injury clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses vary and may not be covered. Participants can expect that the trial covers treatments and assessments related to the study.

Actively Recruiting

Phase 4

Age: 18Years - 70Years

All Genders

ID07072624

Trial to Prevent Early Seizures After Traumatic Brain Injury Using Phenytoin, Levetiracetam, or Placebo Evaluating Drug Effects, Genetic Factors, and Cost-Effectiveness

Led by All India Institute of Medical Sciences, Jodhpur · Updated on 2025-08-06

1260

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the prevention of early post-traumatic seizures PTS in patients with traumatic brain injury TBI. This multicentric, prospective, randomized, placebo-controlled, double-blinded study aims to compare the seizure incidence and effectiveness of two anti-epileptic drugs, phenytoin and levetiracetam, against a placebo. The study also investigates how genetic differences affect seizure occurrence and the safety and cost-effectiveness of these treatments. Participants will be randomly assigned to one of three groups the phenytoin group, the levetiracetam group, or the placebo group. The phenytoin group receives an intravenous loading dose followed by maintenance doses, transitioning to oral medication within one week post-injury. The levetiracetam group receives intravenous doses twice daily, then switches to oral extended-release tablets for one week. The placebo group receives matching saline infusions and placebo tablets over the same period. Genetic testing will be performed to analyze drug polymorphisms. During the study, participants will be monitored for clinical seizures within seven days after injury, with follow-ups at hospital discharge, six months, and one year. Assessments include Glasgow Coma Scale and Glasgow Outcome Scale scores, genetic polymorphism analysis, and a cost-effectiveness evaluation of the drugs. The total study duration involves monitoring seizure occurrence early after injury and longer-term clinical and functional outcomes.

CONDITIONS

Brief Title

Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)

Who Can Participate

Age: 18Years - 70Years

All Genders

Eligibility Criteria

You may qualify if you...

Patients with severe blunt traumatic brain injury and Glasgow Coma Scale score less than 10
Patients with Glasgow Coma Scale above 10 with CT findings of brain injury such as subarachnoid hemorrhage, subdural hematoma, epidural hematoma, intracerebral hemorrhage, diffuse axonal injury, or depressed skull fracture
Patients with penetrating brain injury

You will not qualify if you...

Females of childbearing age with a positive urine pregnancy test
Patients with devastating brain injury expected or confirmed brain death within 48 hours of hospital admission
Patients who used anticonvulsants before hospital admission
Patients who developed seizures before enrollment

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 week

Participants receive a loading dose followed by maintenance doses of either Phenytoin, Levetiracetam, or placebo intravenously and then orally as they become able to take oral medication. Treatment lasts for 1 week after traumatic brain injury.

Daily visits for 1 week

Follow-up

Duration - Up to 1 year

Participants are assessed for clinical seizures and neurological outcomes at hospital discharge, 6 months, and 1 year after treatment.

Visits at hospital discharge, 6 months, and 1 year