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

Not Applicable

• Conditions: Seizures
• Interventions: Other: Group 4 weeks; Other: Group 12 weeks

• Registration Number: NCT03181945
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief Summary

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

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)

Study Timeline

• Study Start: 2016-05-01
• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-06-07
• Study First Posted: 2017-06-09
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-26
• Last Update Posted: 2018-09-28
• Primary Completion: 2018-09-30
• Study Completion: 2019-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 4 weeks	Group 4 weeks	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	Group 12 weeks	Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 12 weeks followed by taper in 10-14days

Primary Outcome Measures

Name	Time	Method
Seizure relapse rate	6 months	Seizure relapse rate (proportion of participants) developing seizures after randomization

Secondary Outcome Measures

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