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

Completed

• Conditions: Partial Onset Seizures; Epilepsy
• Interventions: Drug: Perampanel

• Registration Number: NCT03836924
• Lead Sponsor: Eisai Pharmaceuticals India Pvt. Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-08
• Study First Submitted QC: 2019-02-08
• Study First Posted: 2019-02-11
• Study Start: 2019-02-18
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Perampanel	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Seizure Frequency per 28 days 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
Percentage of Participants Who Experienced at Least 50 Percent Reduction From Baseline in Seizure Frequency During the Treatment Period	Up to 6 months

Trial Locations

Locations (12)

BGS Gleneagles Global Hospitals; 🇮🇳 Bengaluru, Karnataka, India

Seth G S Medical College & KEM Hospital; 🇮🇳 Mumbai, Maharashtra, India

Brain Clinic, Jasleen Hospital; 🇮🇳 Nagpur, Maharashtra, India

Deenanath Mangeshkar Hospital and Research Centre; 🇮🇳 Pune, Maharashtra, India

Ramakrishna mission seva pratisthan vivekananda institute of medical sciences; 🇮🇳 Kolkata, West Bengal, India

Getwell Hospital and Research Institute; 🇮🇳 Nagpur, Maharashtra, India

Nizam's Institute of Medical Sciences Department of Neurology; 🇮🇳 Hyderabad, Telangana, India

Lifepoint Multispecialty Hospital; 🇮🇳 Pune, Maharashtra, India

Shri Ganga Ram Hospital; 🇮🇳 Delhi, India

Sri Aurobindo Seva Kendra; 🇮🇳 Kolkata, West Bengal, India

Sanjay Gandhi Post Graduate Institute of Medical Sciences; 🇮🇳 Lucknow, Uttar Pradesh, India

Advance Neurology & Superspeciality Hospital; 🇮🇳 Jaipur, India