Health Condition 1: G405- Epileptic seizures related to external causes
Conditions
Interventions
Intervention1: MAST DURATION less than 3 months: TBI patients with early seizures (within first 7 days following trauma) will receive a short course of up to 3 months of either Phenytoin Sodium or Lev
Sponsors
National Institute of Mental Health and Neurosciences (NIMHANS)
National Institute for Health and Care Research
Eligibility
Inclusion criteria
Inclusion criteria: MAST DURATION Inclusion Criteria: Patients aged =10 years with TBI managed in an NSU who have started on an phenytoin or levetiracetam due to an acute symptomatic seizure during acute hospitalisation Patient or Legal Representative is willing and able to provide informed consent or in the absence of a legal representative, an Independent Healthcare Professional provides authorisation for patient enrolment MAST PROPHYLAXIS Inclusion Criteria: Patients aged =10 years, with TBI managed in an NSU without an acute symptomatic seizure Patient or Legal Representative is willing and able to provide informed consent or in the absence of a legal representative, an Independent Healthcare Professional provides authorisation for patient enrolment within 48 hours of admittance.
Exclusion criteria
Exclusion criteria: MAST DURATION Unsurvivable injury Previous history of epilepsy Patients who are on an AED pre-TBI Patient who has been clinically prescribed an AED other than phenytoin or levetiracetam Unwillingness to take products containing gelatin (animal products) Severe lactose intolerance or any known hypersensitivity to study drug or any of its excipients MAST PROPHYLAXIS Post-traumatic seizures Unsurvivable injury Previous history of epilepsy Patients who are on an AED pre-TBI Pregnancy or breastfeeding Unwillingness to take products containing gelatin (animal products) Severe lactose intolerance or any known hypersensitivity to study drug or any of its excipients Time interval from the time of admission to NSU to randomisation exceeds 48 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MAST-DURATION: the occurrence of late post-traumatic seizure. MAST-PROPHYLAXIS: is the occurrence of an acute symptomatic seizure.Timepoint: MAST-DURATION: Within 24 months post traumatic brain injury MAST-PROPHYLAXIS: Occurrence of post-traumatic seizures within 2 weeks post TBI | — |
Secondary
| Measure | Time frame |
|---|---|
| • Extended Glasgow Outcome Scale, Neurobehavioural Symptom Inventory, quality of life (EQ-5D-5L), and Liverpool Adverse EventsTimepoint: At 6, 12, 18 and 24 months;Frequency of adverse events of special interest (unfavourable and unintended sign, symptom, or disease temporally associated with the use of trial drug, whether or not considered related to the trial drug.Timepoint: Up to 24 months;MortalityTimepoint: Death from any cause;THe frequency of post traumatic seizuresTimepoint: Within 24 months post traumatic brain injury | — |
Countries
India
Contacts
Public ContactDhaval Shukla
National Institute of Mental Health and Neurosciences, Bengaluru
Outcome results
None listed