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

Perampanel vs Levetiracetam as first line anti-epileptic drug in adult patients with new onset focal seizures: An open labelled, non-inferiority, randomized trial - nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064453

Enrollment

Registered

2024-03-19

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: G401- Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures

Interventions

Intervention1: Perampanel 4 mg once daily: Initial dose of Perampanel will be 4 mg orally once daily following which dose will be further increased maximum till 8 mg once daily if seizure persists Con

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Changes in seizure frequency and retention rateTimepoint: at baseline, at time of discharge, at 1 month and then at 3 month follow up	—

Secondary

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactDr Archisman Haldar

AIIMS Bhubaneswar

archismnaaiimsbbsr13@gmail.com9668741050

Outcome results

None listed

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