Duration of Anti-convulsant Therapy for Acute Symptomatic Seizure in Acute Encephalitis Syndrome

Study Overview
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Brief Summary
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There are no guidelines or studies evaluating duration of anti-epileptic drugs in central nervous system infections. The duration of anti-epileptic drug is extrapolated from traumatic brain injury in which duration of 1 weeks to 3 months is suggested. So the investigators plan to conduct this study to decide the optimal duration of anti-epileptic drug in acute symptomatic seizure in central nervous system infections

Detailed Description
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Demography data, seizure details at diagnosis of acute encephalitis syndrome, details of etiology, neuroimaging findings and electroencephalography. A detailed neurological examination will be done in all participants and asked for seizure semiology at admission. Seizure details include seizure type, duration, number of seizures, number of days for which seizures were recurring, status epilepticus, encephalopathy in between seizures. After the initial assessment participants would be randomized into 2 groups: Group 1: Anti-epileptic drug for 4 weeks followed by taper in 10-14days and Group 2: Anti-epileptic drug for 12 weeks followed by tapering over 10-14days. The primary outcome would be be to study the seizure relapse rate (proportion) after stopping anti-epileptic drugs in participants with acute symptomatic seizure given 4weeks and 12 weeks anti-epileptic drug therapy in the two study groups. Clinical status will be assessed at enrollment as defined by Pediatric Cerebral Performance Category, Pediatric overall Performance Category and Glasgow Outcome Scale-Extended Pediatric Version (GOS-P)

Official Title
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Comparison of 4 Weeks Versus 12 Weeks Anti-convulsant Therapy for Acute Symptomatic Seizure in Children With Acute Encephalitis Syndrome- Open Label, Randomized Controlled Trial

Conditions
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Seizures

Intervention / Treatment
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* Other: Group 4 weeks
* Other: Group 12 weeks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with acute encephalitis syndrome with acute symptomatic seizures on single anti-epileptic drug will be enrolled in Out patient clinic at 4 weeks of illness Exclusion Criteria Children with chronic meningitis, brain abscess, intracranial Space occupying lesion Children with prior history of seizures, prior focal neurological deficit Children with abnormal development prior to development of seizures HIV, Chronic Liver disease, Chronic Kidney disease, acute hepatic encephalopathy Children on two or more than 2 anti-epileptic drugs Severely affected children (Pediatric Cerebral Performance Category Scale (PCPC) Score, Pediatric Overall Performance Category Scale with category score of 5) Refusal of consent

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Whether 4 weeks anti-epileptic drug is as efficacious as 12 weeks anti-epileptic drug therapy for Acute Encephalitis syndrome
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 4 weeks<br>Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 4 weeks followed by taper in 10-14days | Other: Group 4 weeks<br>* Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 4 weeks followed by taper in 10-14days<br>|
| Active Comparator: Group 12 weeks<br>Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 12 weeks followed by taper in 10-14days | Other: Group 12 weeks<br>* Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 12 weeks followed by taper in 10-14days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure relapse rate | Seizure relapse rate (proportion of participants) developing seizures after randomization | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of EEG findings at time of stoppage of anti-epileptic drug with seizure recurrence | Correlation of EEG at randomization and seizure recurrence will be done | 6 months | 
| Factors associated with seizure recurrence | Factors associated with seizure recurrence in the two groups | 6 months | 
| Seizure relapse rate | Seizure relapse rate (proportion of participants) developing seizures after randomization | 12 months | 
| Seizure relapse rate | Seizure relapse rate (proportion of participants) developing seizures after randomization | 18 months | 
| Seizure relapse rate | Seizure relapse rate (proportion of participants) developing seizures after randomization | 24 months |