Health Condition 1: G409- Epilepsy, unspecified
Conditions
Interventions
Intervention1: Perampanel: Dose- 2mg per day upto 8 mg per day based on clinical response by oral route
Control Intervention1: Clobazam: Dose- 5 mg per day upto 10 mg per day as per clinical response.
Sponsors
Dr Ayush Gupta
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 4-12 years with a diagnosis of epilepsy receiving valproate at minimum 30mg/kg/day coming with breakthrough seizure will be included.
Exclusion criteria
Exclusion criteria: Children who have poor compliance with valproate, those on multiple antiepileptic drugs, those receiving first line antiepileptic other than valproate, or those with chronic kidney or liver will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients attaining complete seizure freedom during 3 months follow up.Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with decrease seizure frequency.Timepoint: 3 months;Incidence and severity of adverse effects (e.g., sedation, dizziness, aggression, mood changes, fatigue, cognitive slowing).Timepoint: 3 months;Discontinuation Rate: Proportion of patients who discontinue treatment due to side effects.Timepoint: 3 months | — |
Countries
India
Contacts
Public ContactAnju Aggrawal
University college of medical sciences and GTB hospital
Outcome results
None listed