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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
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seizures

Eligibility Criteria

3 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 2, 2017
    Last Updated
    September 26, 2018
    Sponsor
    Postgraduate Institute of Medical Education and Research
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    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

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

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