Duration of Anti-convulsant Therapy for Acute Symptomatic Seizure in Acute Encephalitis Syndrome
Primary Purpose
Seizures
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group 4 weeks
Group 12 weeks
Sponsored by
About this trial
This is an interventional treatment trial for Seizures
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 4 weeks
Group 12 weeks
Arm Description
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 12 weeks followed by taper in 10-14days
Outcomes
Primary Outcome Measures
Seizure relapse rate
Seizure relapse rate (proportion of participants) developing seizures after randomization
Secondary Outcome Measures
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
Factors associated with seizure recurrence
Factors associated with seizure recurrence in the two groups
Seizure relapse rate
Seizure relapse rate (proportion of participants) developing seizures after randomization
Seizure relapse rate
Seizure relapse rate (proportion of participants) developing seizures after randomization
Seizure relapse rate
Seizure relapse rate (proportion of participants) developing seizures after randomization
Full Information
NCT ID
NCT03181945
First Posted
June 2, 2017
Last Updated
September 26, 2018
Sponsor
Postgraduate Institute of Medical Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT03181945
Brief Title
Duration of Anti-convulsant Therapy for Acute Symptomatic Seizure in Acute Encephalitis Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
September 30, 2018 (Anticipated)
Study Completion Date
February 28, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
Open label study
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 4 weeks
Arm Type
Active Comparator
Arm Description
Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 4 weeks followed by taper in 10-14days
Arm Title
Group 12 weeks
Arm Type
Active Comparator
Arm Description
Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 12 weeks followed by taper in 10-14days
Intervention Type
Other
Intervention Name(s)
Group 4 weeks
Intervention Description
Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 4 weeks followed by taper in 10-14days
Intervention Type
Other
Intervention Name(s)
Group 12 weeks
Intervention Description
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 Measure Information:
Title
Seizure relapse rate
Description
Seizure relapse rate (proportion of participants) developing seizures after randomization
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Correlation of EEG findings at time of stoppage of anti-epileptic drug with seizure recurrence
Description
Correlation of EEG at randomization and seizure recurrence will be done
Time Frame
6 months
Title
Factors associated with seizure recurrence
Description
Factors associated with seizure recurrence in the two groups
Time Frame
6 months
Title
Seizure relapse rate
Description
Seizure relapse rate (proportion of participants) developing seizures after randomization
Time Frame
12 months
Title
Seizure relapse rate
Description
Seizure relapse rate (proportion of participants) developing seizures after randomization
Time Frame
18 months
Title
Seizure relapse rate
Description
Seizure relapse rate (proportion of participants) developing seizures after randomization
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sumeet Dhawan, MD
Organizational Affiliation
Post Graduate Institute of Medical Education and Research
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34543779
Citation
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.
Results Reference
derived
Learn more about this trial
Duration of Anti-convulsant Therapy for Acute Symptomatic Seizure in Acute Encephalitis Syndrome
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