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.

Evaluation of intermittent Clobazam prophylaxis in children aged 6 months to 5 years with Complex Febrile Seizures already on continuous prophylaxis with Sodium Valproate ; a randomized control trial - nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063676

Enrollment

Registered

2024-03-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: R560- Febrile convulsions

Interventions

Intervention1: INTERMITTENT CLOBAZAM PROPHYLAXIS: The patients’ attendant will be instructed to administer clobazam in group A(intervention arm) during the febrile episodes irrespective of the child’s

5kg-2.5 mg twice daily, &gt

5-10 kg-5 mg BD, 10-15 Kg-7.5 mg BD, &gt

15 Kg-10 mg BD) for 72 hrs/6 doses Control Intervention1: NIL: Standard prophylaxis of sodium Valproate and antipyretics will be continued

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Estimate the incidence of seizure recurrence with febrile episodeTimepoint: 6 months	—

Secondary

Measure	Time frame
Ascertain incidence of adverse effects of adjuvant intermittent clobazam prophylaxis.Timepoint: 6 months	—

Countries

India

Contacts

Public ContactDr Awnish Kumar Mishra

Command Hospital Southern Commond

drashokyadavpaed@yahoo.co.in9969034427

Outcome results

None listed

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