Actively Recruiting

Phase 4
Age: 18Years - 70Years
All Genders
ID07072624

Assessing Phenytoin and Levetiracetam Efficacy, Cost-Effectiveness, and CYP2C9/SV2A Polymorphism in Early Post-Traumatic Seizures: A Multicentric Prospective Randomized Trial

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

1260

Participants Needed

3

Research Sites

52 weeks

Total Duration

On this page

Sponsors

A

All India Institute of Medical Sciences, Jodhpur

Lead Sponsor

I

Indian Council of Medical Research

Collaborating Sponsor

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

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

Trial Site Locations

Total: 3 locations

1

Postgraduate Institute of Medical Education & Research

Chandigarh, Punjab, India, 160012

Actively Recruiting

2

AIIMS Jodhpur

Jodhpur, Rajasthan, India, 342005

Actively Recruiting

3

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, India

Actively Recruiting

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Research Team

D

Dr Jaskaran Singh Gosal Associate Professor, MCh Neurosurgery

D

Dr Shoban Babu Varthya Associate Professor, MD Pharmacology

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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Published Research Related To This Trial

Clinical relevance of genetic polymorphism in CYP2C9 gene to pharmacodynamics and pharmacokinetics of phenytoin in epileptic patients: validatory pharmacogenomic approach to pharmacovigilance.

Shazia Kousar, Zahoor A Wafai, Mushtaq A Wani...

https://pubmed.ncbi.nlm.nih.gov/25943175

Prospective, randomized, single-blinded comparative trial of intravenous levetiracetam versus phenytoin for seizure prophylaxis.

Jerzy P Szaflarski, Kiranpal S Sangha, Christopher J Lindsell...

https://pubmed.ncbi.nlm.nih.gov/19898966