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

NCT ID: NCT03836924

Last Updated: 2021-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-18

Study Completion Date

2020-03-01

Brief Summary

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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

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Conditions

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Partial Onset Seizures Epilepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Perampanel

Intervention Type DRUG

Perampanel tablets.

Interventions

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Perampanel

Perampanel tablets.

Intervention Type DRUG

Other Intervention Names

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E2007 Fycompa

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Pharmaceuticals India Pvt. Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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BGS Gleneagles Global Hospitals

Bengaluru, Karnataka, India

Site Status

Seth G S Medical College & KEM Hospital

Mumbai, Maharashtra, India

Site Status

Brain Clinic, Jasleen Hospital

Nagpur, Maharashtra, India

Site Status

Getwell Hospital and Research Institute

Nagpur, Maharashtra, India

Site Status

Deenanath Mangeshkar Hospital and Research Centre

Pune, Maharashtra, India

Site Status

Lifepoint Multispecialty Hospital

Pune, Maharashtra, India

Site Status

Nizam's Institute of Medical Sciences Department of Neurology

Hyderabad, Telangana, India

Site Status

Sanjay Gandhi Post Graduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, India

Site Status

Ramakrishna mission seva pratisthan vivekananda institute of medical sciences

Kolkata, West Bengal, India

Site Status

Sri Aurobindo Seva Kendra

Kolkata, West Bengal, India

Site Status

Shri Ganga Ram Hospital

Delhi, , India

Site Status

Advance Neurology & Superspeciality Hospital

Jaipur, , India

Site Status

Countries

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India

Other Identifiers

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E2007-M091-508

Identifier Type: -

Identifier Source: org_study_id

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