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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03836924
• Other study ID #: E2007-M091-508
• Status: Completed
• Start date: February 18, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: February 2021
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Partial Onset Seizures
• Seizures

Intervention

Drug:
• Perampanel
Perampanel tablets.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Pharmaceuticals India Pvt. Ltd

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)		Up to 6 months
Secondary	Percent Change From Baseline in Seizure Frequency per 28 days During the Treatment Period		Up to 6 months
Secondary	Percentage of Participants Who Experienced at Least 50 Percent Reduction From Baseline in Seizure Frequency During the Treatment Period		Up to 6 months
Secondary	Percentage of Participants Who Achieved a Seizure-free Status During the Treatment Period		At 3 months and 6 months