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Reducing seizure recurrence in children with febrile seizure

Randomised Control Trial to study effectiveness of intermittent oral levetiracetam compared to clobazam in reducing seizure recurrence in children with febrile seizure during 48 weeks followup

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/044437
Enrollment
110
Registered
2022-07-28
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G409- Epilepsy, unspecified

Interventions

Intervention1: Levetiracetam: Patients in the Levetiracetam group received oral Levetiracetam at a dose of 15ââ?¬â??30 mg/kg per day twice daily at the onset of fever (T 37.5Ã?°C) for 1 week (thera

Sponsors

Dr Rajkumar Surya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children more than 1 month till 59 months, with history of two or more episodes of febrile seizures within the last 6 months

Exclusion criteria

Exclusion criteria: Episodes of previous seizures without fever, no Intracranial infections, no Head trauma, no structural or developmental anomalies of CNS, no history of intoxication and electrolyte disturbances, no congenital metabolic disease or chronic disease for which AED have to be prescribed for longer duration. All children on current use of anti-epileptic drugs, those parents who refuse consent or residing at distance of more than 30 km from hospital, and cannot come for follow -up will also be excluded

Design outcomes

Primary

MeasureTime frame
To assess the effectiveness of oral intermittent levetiracetam vs clobazam in controlling seizure frequency associated with febrile events and febrile seizure recurrence rateTimepoint: 48 weeks follow up

Secondary

MeasureTime frame
The primary variable in efficacy is seizure frequency associated with febrile events and FS recurrence rate (RR) during the 48-week follow-up. � The second variable in efficacy will be the side effects associated with the drugs.Timepoint: 48 weeks follow up

Countries

India

Contacts

Public ContactDr Mangla Sood

IGMC Shimla

drmanglasood@gmail.com9418453465

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026