A Prospective, Multicenter, Post-marketing Surveillance to Assess Safety & Efficacy of Perampanel in Indian Patients as an Adjunctive Treatment inPartial Onset Seizures with or Without Secondary Generalized Seizures in Patients with Epilepsy Aged 12 years or older.
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 12
- Primary Endpoint
- of age 12 years and older with epilepsy.
Study Overview
Brief Summary
Prospective, multicenter, open label, non-comparative, post-marketing surveillance study to evaluate safety & efficacy of perampanel as adjunctive therapy in patients with partial onset seizures with or with secondary generalized seizure of age 12 years and older.
Up-to 200 Indian patients across 10 centers from India will be enrolled to receive perampanel based on independent clinical judgment of treating physicians/Principle Investigator as per the approved Package Insert in India. Once enrolled, patients will be observed prospectively for a period of 6 months or till the patients withdraw from the study (for either lack of efficacy or intolerance or the patient is lost to follow up) whichever is earlier. Seizure diaries will be issued to the patients.
The study will consist of Screening and Enrolment Visit (Day 1) and Treatment Period (6 months). For each participant, visits during the Treatment Period will be conducted each month.
Participants will be monitored during the treatment of perampanel for 6 months & up to 30 days post treatment period of 6 months in case of SAE or till the patients’ withdrawal from the study for collection of adverse events.
Participants’ safety will be monitored throughout the study.
The total duration of the study will be 12 months.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 12.00 Year(s) to 90.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male or female patients age greater than or equal to 12 years at the time of informed consent
- •Patients prescribed perampanel for the adjunctive treatment of partial onset seizures based on independent clinical judgment of treating physicians.
- •Patients who provide informed consent to the treating physician.
Exclusion Criteria
- •Participation in another study involving administration of an investigational drug or device whilst participating in this observational study
- •Hypersensitivity [allergic] to perampanel.
Outcomes
Primary Outcomes
of age 12 years and older with epilepsy.
Time Frame: 6 Months
To assess the safety of perampanel in the treatment of partial onset seizures in patients
Time Frame: 6 Months
Secondary Outcomes
- ô€¸ To assess the change in seizure frequency with perampanel as adjunctive treatment of(partial onset seizures in patients of age 12 years and older with epilepsy)