Post Marketing Study of Perampanel in Patients with Epilepsy
Phase 4
Completed
- Conditions
- Health Condition 1: G401- Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures
- Registration Number
- CTRI/2019/01/016844
- Lead Sponsor
- Eisai Pharmaceutical India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. Male or female patients age greater than or equal to 12 years at the time of informed
consent
2. Patients prescribed perampanel for the adjunctive treatment of partial onset seizures
based on independent clinical judgment of treating physicians.
3. Patients who provide informed consent to the treating physician.
Exclusion Criteria
1. Participation in another study involving administration of an investigational drug or
device whilst participating in this observational study
2. Hypersensitivity [allergic] to perampanel
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the safety of perampanel in the treatment of partial onset seizures in patients <br/ ><br>of age 12 years and older with epilepsy.Timepoint: 6 Months
- Secondary Outcome Measures
Name Time Method ô??¸ To assess the change in seizure frequency with perampanel as adjunctive treatment of <br/ ><br>partial onset seizures in patients of age 12 years and older with epilepsy <br/ ><br>ô??¸ To assess the responder rate (50% seizure frequency reduction) with perampanel as <br/ ><br>adjunctive treatment of partial onset seizures in patients of age 12 years and older with <br/ ><br>epilepsy <br/ ><br>ô??¸ To evaluate proportion of seizure free patients at the end of 3-months, and 6-months <br/ ><br>and last 3 months during the treatment period.Timepoint: 3 and 6 months