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comparing 2 tablets for treating fits in children

Comparison of the efficacy of sodium valproate with levetiracetam in controlling seizure in the age group of 2 to 18 years, a randomised control trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018520
Enrollment
116
Registered
2019-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: G939- Disorder of brain, unspecified

Interventions

Intervention1: Levetiracetam: Levetiracetam 10-20 mg/kg/day increase by 10mg/kg/day every 1-2 week upto 40-60 mg/kg/day For 6 months Control Intervention1: Sodium valproate: 20 mg/kg/day .maximum do

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children 2 TO 18 years of age with new onset of epilsey(as per International league against epilepsy (ILAE) 2017

Exclusion criteria

Exclusion criteria: 1. Childeren with First episode of seizure 2. Febrile seizures 3. Cerebral palsy,Cranial Malformations 4. Patients presenting with status epilepticus 5. Absence seizures(13) 6. Suspected allergy to Levetiracetam or Sodium valproate 7. Acute or chronic liver or kidney disease,family history of hepatic dysfunction,pancreatitis, porphyria, 8. Epileptic encephalopathy 9. Syndromic seizures

Design outcomes

Primary

MeasureTime frame
Percentage of children with Seizure free for 3 Continuous months,Timepoint: Percentage of children with Seizure free for 3 Continuous months,—

Secondary

MeasureTime frame
seizure reduction by 50% , number of patients with relapse status, adverse effect and toxicity profile. Timepoint: 3 months—

Countries

India

Contacts

Public ContactDr N Biswal

JIPMER

drnbiswal@yahoo.com9442528402

Outcome results

None listed

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