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

Seizures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03181945
• Other study ID #: INT/IEC/2016/114
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: February 28, 2019

Study information

• Verified date: September 2018
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: February 28, 2019
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Encephalitis
• Seizures

Intervention

Other:
• 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
Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 12 weeks followed by taper in 10-14days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure relapse rate	Seizure relapse rate (proportion of participants) developing seizures after randomization	6 months
Secondary	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
Secondary	Factors associated with seizure recurrence	Factors associated with seizure recurrence in the two groups	6 months
Secondary	Seizure relapse rate	Seizure relapse rate (proportion of participants) developing seizures after randomization	12 months
Secondary	Seizure relapse rate	Seizure relapse rate (proportion of participants) developing seizures after randomization	18 months
Secondary	Seizure relapse rate	Seizure relapse rate (proportion of participants) developing seizures after randomization	24 months