A Study to Assess Safety and Efficacy of Perampanel in Indian Participants as an Adjunctive Treatment in Partial Onset Seizures With or Without Secondary Generalized Seizures in Participants With Epilepsy Aged 12 Years or Older

Eisai Pharmaceuticals India Pvt. Ltd200 enrolled

Overview

The purpose of this study is to assess the safety of perampanel in the treatment of partial onset seizures in participants of age 12 years and older with epilepsy.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Partial Onset Seizures Epilepsy

Interventions

PerampanelDRUG

Perampanel tablets.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants prescribed perampanel for the adjunctive treatment of partial onset seizures based on independent clinical judgment of treating physicians. Exclusion Criteria: * Participation in another study involving administration of an investigational drug or device whilst participating in this observational study. * Hypersensitivity \[allergic\] to perampanel.

Locations (12)

BGS Gleneagles Global Hospitals

Bengaluru, Karnataka, India

Seth G S Medical College & KEM Hospital

Mumbai, Maharashtra, India

Brain Clinic, Jasleen Hospital

Nagpur, Maharashtra, India

Outcomes

Primary Outcomes

Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame: Up to 6 months

Secondary Outcomes

Percent Change From Baseline in Seizure Frequency per 28 days During the Treatment Period

Time frame: Up to 6 months

Percentage of Participants Who Experienced at Least 50 Percent Reduction From Baseline in Seizure Frequency During the Treatment Period

Time frame: Up to 6 months

Percentage of Participants Who Achieved a Seizure-free Status During the Treatment Period

Time frame: At 3 months and 6 months

Data from ClinicalTrials.gov

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