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
A Prospective, Multicenter, Post-marketing Surveillance to Assess Safety & Efficacy of Perampanel in Indian Patients as An Adjunctive Treatment in Partial Onset Seizures With or Without Secondary Generalized Seizures in Patients With Epilepsy Aged 12 Years or Older
1 other identifier
observational
200
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2019
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2019
CompletedFirst Posted
Study publicly available on registry
February 11, 2019
CompletedStudy Start
First participant enrolled
February 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedFebruary 18, 2021
February 1, 2021
1 year
February 8, 2019
February 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Up to 6 months
Secondary Outcomes (3)
Percent Change From Baseline in Seizure Frequency per 28 days During the Treatment Period
Up to 6 months
Percentage of Participants Who Experienced at Least 50 Percent Reduction From Baseline in Seizure Frequency During the Treatment Period
Up to 6 months
Percentage of Participants Who Achieved a Seizure-free Status During the Treatment Period
At 3 months and 6 months
Study Arms (1)
Perampanel
Participants receiving perampanel tablets, orally according to prescribing information and the treating physician's clinical judgment will be observed prospectively for up to 6 months or participant withdrawal, whichever occurs first.
Interventions
Eligibility Criteria
Indian participants with epilepsy aged 12 years or older.
You may qualify if:
- Participants prescribed perampanel for the adjunctive treatment of partial onset seizures based on independent clinical judgment of treating physicians.
You may not qualify if:
- Participation in another study involving administration of an investigational drug or device whilst participating in this observational study.
- Hypersensitivity \[allergic\] to perampanel.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
BGS Gleneagles Global Hospitals
Bengaluru, Karnataka, 560060, India
Seth G S Medical College & KEM Hospital
Mumbai, Maharashtra, 400012, India
Brain Clinic, Jasleen Hospital
Nagpur, Maharashtra, 440012, India
Getwell Hospital and Research Institute
Nagpur, Maharashtra, 440012, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, 411004, India
Lifepoint Multispecialty Hospital
Pune, Maharashtra, 411057, India
Nizam's Institute of Medical Sciences Department of Neurology
Hyderabad, Telangana, 500082, India
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, 226014, India
Ramakrishna mission seva pratisthan vivekananda institute of medical sciences
Kolkata, West Bengal, 700026, India
Sri Aurobindo Seva Kendra
Kolkata, West Bengal, 700068, India
Shri Ganga Ram Hospital
Delhi, India
Advance Neurology & Superspeciality Hospital
Jaipur, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2019
First Posted
February 11, 2019
Study Start
February 18, 2019
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
February 18, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.