A clinical trial to study the effectiveness of Perampanel compared to Levetiracetam as first line anti-seizure drug in adult patients with new onset focal seizures
Phase 3
- Conditions
- Health Condition 1: G401- Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures
- Registration Number
- CTRI/2024/03/064453
- Lead Sponsor
- AIIMS Bhubaneswar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Age more than or equal to 18 years
Those willing to give consent
First time detected new onset focal seizures with or without secondary generalization
Exclusion Criteria
Pregnant women
Patients with current or previous seizure semiologies other than focal seizures
Generalized epilepsy syndrome
EEG findings suggestive of idiopathic generalized epilepsy
Patients presenting with status epilepticus
Acute or chronic kidney disease with creatinine clearance less than 30 ml per min
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in seizure frequency and retention rateTimepoint: at baseline, at time of discharge, at 1 month and then at 3 month follow up
- Secondary Outcome Measures
Name Time Method To compare the safety profile of Perampanel & Levetiracetam in patients receiving these drugsTimepoint: at admission, at discharge, at 1 month & at 3 months follow up