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

Sponsor

Eisai Pharmaceuticals India Pvt. Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT03836924

Collaborator

(none)

200

Enrollment

Locations

12.4

Actual Duration (Months)

16.7

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Partial Onset Seizures Epilepsy	Drug: Perampanel

Study Design

Study Type:

Observational

Actual Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 18, 2019

Actual Primary Completion Date :

Mar 1, 2020

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

Arm	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: E2007 Fycompa

Arm

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:

E2007

Fycompa

Outcome Measures

Primary Outcome Measures

Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Up to 6 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

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