A randomised controlled trial to study efficacy of intermittent seizure prophylaxis with Clobazam in patients of complex febrile seizures already on continuous sodium valproate prophylaxis.
Phase 3
- Conditions
- Health Condition 1: R560- Febrile convulsions
- Registration Number
- CTRI/2024/03/063676
- Lead Sponsor
- Armed forces medical college
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All children aged 06 months- 5years, with complex febrile
seizures, already on continuous valproate prophylaxis for minimum of 1 month presenting to Pediatric or Pediatric Neurology OPD or admitted in Pediatric ward
Exclusion Criteria
Patients presenting with
1)afebrile seizures,
2) Combination of febrile seizures with afebrile seizures
3) Genetically proven channelopathies.
4) Global developmental delay
5) Congenital malformations
6)Cause of fever being intracranial infection
7) Chid with deranged renal or hepatic functions
8)On antiseizure medications other than sodium valproate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Estimate the incidence of seizure recurrence with febrile episodeTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method Ascertain incidence of adverse effects of adjuvant intermittent clobazam prophylaxis.Timepoint: 6 months