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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03836924

Enrollment

200

Registered

2019-02-11

Start date

2019-02-18

Completion date

2020-03-01

Last updated

2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Partial Onset Seizures

Keywords

E2007, Fycompa, Perampanel, Prospective, Partial onset seizures, Epilepsy, Seizures

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.

Interventions

DRUGPerampanel

Perampanel tablets.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026