- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03181945
Duration of Anti-convulsant Therapy for Acute Symptomatic Seizure in Acute Encephalitis Syndrome
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 4 weeks followed by taper in 10-14days
|
Active Comparator: 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
|
Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 12 weeks followed by taper in 10-14days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seizure relapse rate
Time Frame: 6 months
|
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
Time Frame: 6 months
|
Correlation of EEG at randomization and seizure recurrence will be done
|
6 months
|
Factors associated with seizure recurrence
Time Frame: 6 months
|
Factors associated with seizure recurrence in the two groups
|
6 months
|
Seizure relapse rate
Time Frame: 12 months
|
Seizure relapse rate (proportion of participants) developing seizures after randomization
|
12 months
|
Seizure relapse rate
Time Frame: 18 months
|
Seizure relapse rate (proportion of participants) developing seizures after randomization
|
18 months
|
Seizure relapse rate
Time Frame: 24 months
|
Seizure relapse rate (proportion of participants) developing seizures after randomization
|
24 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sumeet Dhawan, MD, Post Graduate Institute of Medical Education and Research
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INT/IEC/2016/114
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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