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

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 Overview

• Status: Completed
• Conditions: Epilepsy; Partial Onset Seizures
• Intervention / Treatment: Drug: Perampanel

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• India
  • Delhi, India
    • Shri Ganga Ram Hospital
  • Jaipur, India
    • Advance Neurology & Superspeciality Hospital
  • Karnataka
    • Bengaluru, Karnataka, India, 560060
      • BGS Gleneagles Global Hospitals
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Seth G S Medical College & KEM Hospital
    • Nagpur, Maharashtra, India, 440012
      • Getwell Hospital and Research Institute
    • Nagpur, Maharashtra, India, 440012
      • Brain Clinic, Jasleen Hospital
    • Pune, Maharashtra, India, 411004
      • Deenanath Mangeshkar Hospital and Research Centre
    • Pune, Maharashtra, India, 411057
      • Lifepoint Multispecialty Hospital
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Nizam's Institute of Medical Sciences Department of Neurology
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226014
      • Sanjay Gandhi Post Graduate Institute of Medical Sciences
  • West Bengal
    • Kolkata, West Bengal, India, 700026
      • Ramakrishna mission seva pratisthan vivekananda institute of medical sciences
    • Kolkata, West Bengal, India, 700068
      • Sri Aurobindo Seva Kendra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Indian participants with epilepsy aged 12 years or older.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Perampanel; Perampanel tablets.; Other Names: Fycompa; E2007

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Eisai Pharmaceuticals India Pvt. Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: February 8, 2019
• First Submitted That Met QC Criteria: February 8, 2019
• First Posted (Actual): February 11, 2019

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Epilepsy; Seizures; Prospective; Perampanel; Partial onset seizures; Fycompa; E2007
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures
• Other Study ID Numbers: E2007-M091-508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No