Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Partial Onset Seizures
Epilepsy
Keywords: E2007
Fycompa
Perampanel
Prospective
Partial onset seizures
Epilepsy
Seizures
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-11
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Indian participants with epilepsy aged 12 years or older.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 6 months
Secondary outcomes:
measure: Percent Change From Baseline in Seizure Frequency per 28 days During the Treatment Period
timeFrame: Up to 6 months
measure: Percentage of Participants Who Experienced at Least 50 Percent Reduction From Baseline in Seizure Frequency During the Treatment Period
timeFrame: Up to 6 months
measure: Percentage of Participants Who Achieved a Seizure-free Status During the Treatment Period
timeFrame: At 3 months and 6 months
Other outcomes:
Locations:
city: Bengaluru
country: India
facility: BGS Gleneagles Global Hospitals
state: Karnataka
city: Mumbai
country: India
facility: Seth G S Medical College & KEM Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Brain Clinic, Jasleen Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Getwell Hospital and Research Institute
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Centre
state: Maharashtra
city: Pune
country: India
facility: Lifepoint Multispecialty Hospital
state: Maharashtra
city: Hyderabad
country: India
facility: Nizam's Institute of Medical Sciences Department of Neurology
state: Telangana
city: Lucknow
country: India
facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences
state: Uttar Pradesh
city: Kolkata
country: India
facility: Ramakrishna mission seva pratisthan vivekananda institute of medical sciences
state: West Bengal
city: Kolkata
country: India
facility: Sri Aurobindo Seva Kendra
state: West Bengal
city: Delhi
country: India
facility: Shri Ganga Ram Hospital
city: Jaipur
country: India
facility: Advance Neurology & Superspeciality Hospital
Study officials:
References: