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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
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 4 weeks | Active Comparator | Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 4 weeks followed by taper in 10-14days |
|
| Group 12 weeks | Active Comparator | Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 12 weeks followed by taper in 10-14days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 4 weeks | Other | Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 4 weeks followed by taper in 10-14days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seizure relapse rate | Seizure relapse rate (proportion of participants) developing seizures after randomization | 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Sumeet Dhawan, MD | Post Graduate Institute of Medical Education and Research, Chandigarh | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34543779 | Derived | Dhawan SR, Sahu JK, Singhi P, Sankhyan N, Jayashree M. Comparison of 4 weeks versus 12 weeks antiseizure medication for acute symptomatic seizures in children with Acute Encephalitis Syndrome: An open-label, randomized controlled trial. Seizure. 2021 Nov;92:182-188. doi: 10.1016/j.seizure.2021.09.005. Epub 2021 Sep 10. |
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| ID | Term |
|---|---|
| D012640 | Seizures |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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Whether 4 weeks anti-epileptic drug is as efficacious as 12 weeks anti-epileptic drug therapy for Acute Encephalitis syndrome
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Open label study
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| Group 12 weeks | Other | Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 12 weeks followed by taper in 10-14days |
|
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 |