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NCT Number: NCT03836924

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

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.

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Key information

Conditions

Partial Onset Seizures Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

BGS Gleneagles Global Hospitals, Bengaluru, Karnataka, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

perampanel

Drug

Perampanel tablets.

Other names: E2007, Fycompa

Primary outcomes

  1. Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 6 months

Secondary outcomes

  1. Percent Change From Baseline in Seizure Frequency per 28 days During the Treatment Period

    Time frame: Up to 6 months

  2. Percentage of Participants Who Experienced at Least 50 Percent Reduction From Baseline in Seizure Frequency During the Treatment Period

    Time frame: Up to 6 months

  3. Percentage of Participants Who Achieved a Seizure-free Status During the Treatment Period

    Time frame: At 3 months and 6 months

Sponsors and collaborators

Lead sponsor

Eisai Pharmaceuticals India Pvt. Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 11, 2019
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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