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

NCT03181945 | Unknown DMC

• 1 other identifier: INT/IEC/2016/114
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Seizures

Outcome Measures

Primary Outcomes (1)

• Seizure relapse rate

  Seizure relapse rate (proportion of participants) developing seizures after randomization

  6 months

Secondary Outcomes (5)

• Correlation of EEG findings at time of stoppage of anti-epileptic drug with seizure recurrence

  6 months

• Factors associated with seizure recurrence

  6 months

• Seizure relapse rate

  12 months

• Seizure relapse rate

  18 months

• Seizure relapse rate

  24 months

Study Arms (2)

Group 4 weeks

ACTIVE COMPARATOR

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

Other: Group 4 weeks

Group 12 weeks

ACTIVE COMPARATOR

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

Other: Group 12 weeks

Interventions

Group 4 weeks OTHER

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

Group 4 weeks

Group 12 weeks OTHER

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

Group 12 weeks

Eligibility Criteria

• Age: 3 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Related Publications (1)

• 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.

  PMID: 34543779 DERIVED

MeSH Terms

Conditions

Seizures

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Sumeet Dhawan, MD

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident, Department of Pediatrics

Model Details: Whether 4 weeks anti-epileptic drug is as efficacious as 12 weeks anti-epileptic drug therapy for Acute Encephalitis syndrome

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 9, 2017
• Study Start: May 1, 2016
• Primary Completion: September 30, 2018
• Study Completion: February 28, 2019
• Last Updated: September 28, 2018

Record last verified: 2018-09