Comparsion of levetiracetam and sodium valproate mono therapy in childhood epilepsy

Recruiting

Conditions: newly diagnosed childhood epilepsy

Registration Number: CTRI/2017/11/010605

Brief Summary: Levetiracetam has proven efficacy in childhood epilepsy. Its intravenous use has been recommended in convulsive status epilepticus. Oral levetiracetam is safe and efficacious in various childhood epilepsies. Its use as monotherapy has been suggested for partial seizures and generalised tonic clonic seizures. There is still a need for well designed trials to justify the widespread use of levetiracetam monotherapy in children.

**Objectives:**

***Primary***To compare the efficacy of levetiracetam and sodium valproate in childhood epilepsy by comparing repeat seizures for 6 months.

***Secondary***

1.To compare side effect profile of levetiracetam and valproate

2.To compare the retention rates of levetiracetam and valproate

3.To compare time to first repeat seizure

4.To compare drug levels at steady state (4 day for leveteracitam and 7th day for valproate).

**STUDY SETTING**

The study will be conducted in Department of Pediatrics, GTB hospital and Department of Neuropsycopharmacology, IHBAS, Delhi. An approval from the ethics committee will be obtained

**PARTICIPANTS**

Children aged 3 to 12 years presenting with newly diagnosed focal motor or generalized epilepsy

**OUTCOME VARIABLES**

**Primary outcome variable**-

Treatment will be considered successful if there is no repeat seizure activity for 6 months.

**Secondary outcome variable-**

1. Side effects profile of the patients in each group

2. Achievement of therapeutic drug levels at steady state and 6 months

3. Time to first seizure after steady state of drug

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 100

Inclusion Criteria

Newly diagnosed focal motor or generalised epilepsy.

Exclusion Criteria

1.Children who are on anti epileptic for more than 15 days 2.Children with congenital anomalies or developmental delay or microcephaly 3.Acute head trauma or post traumatic epilepsy.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment will be considered successful if there is no repeat seizure activity for 6 months	Treatment will be considered successful if there is no repeat seizure activity for 6 months

Secondary Outcome Measures

Name	Time	Method
1.Side effect profile of the patients in each group	2.Achievement of therapeutic drug levels at steady state and 6 months

Trial Locations

Locations (1): Guru tegh Bahadur hospital
🇮🇳
East, DELHI, India
Guru tegh Bahadur hospital
🇮🇳East, DELHI, India
Dr Swati Bhayana
Principal investigator
9582026730
swatibh1312@gmail.com