Post Marketing Study of Perampanel in Patients with Epilepsy

Not Applicable

Completed

• Conditions: Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures,

• Registration Number: CTRI/2019/01/016844
• Lead Sponsor: Eisai Pharmaceutical India Limited

Brief Summary

Prospective, multicenter, open label, non-comparative, post-marketing surveillance study to evaluate safety & efficacy of perampanel as adjunctive therapy in patients with partial onset seizures with or with secondary generalized seizure of age 12 years and older.



Up-to 200 Indian patients across 10 centers from India will be enrolled to receive perampanel based on independent clinical judgment of treating physicians/Principle Investigator as per the approved Package Insert in India. Once enrolled, patients will be observed prospectively for a period of 6 months or till the patients withdraw from the study (for either lack of efficacy or intolerance or the patient is lost to follow up) whichever is earlier. Seizure diaries will be issued to the patients.



The study will consist of Screening and Enrolment Visit (Day 1) and Treatment Period (6 months). For each participant, visits during the Treatment Period will be conducted each month.



Participants will be monitored during the treatment of perampanel for 6 months & up to 30 days post treatment period of 6 months in case of SAE or till the patients’ withdrawal from the study for collection of adverse events.



Participants’ safety will be monitored throughout the study.



The total duration of the study will be 12 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-18
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

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

Inclusion Criteria

• Male or female patients age greater than or equal to 12 years at the time of informed consent 2.
• Patients prescribed perampanel for the adjunctive treatment of partial onset seizures based on independent clinical judgment of treating physicians.
• Patients who provide informed consent to the treating physician.

Exclusion Criteria

• Participation in another study involving administration of an investigational drug or device whilst participating in this observational study 2.
• Hypersensitivity [allergic] to perampanel.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
of age 12 years and older with epilepsy.	6 Months
To assess the safety of perampanel in the treatment of partial onset seizures in patients	6 Months

Secondary Outcome Measures

Name	Time	Method
ô€¸ To assess the change in seizure frequency with perampanel as adjunctive treatment of	partial onset seizures in patients of age 12 years and older with epilepsy

Trial Locations

Locations (12)

Advanced Neurology & Superspecialty Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

BGS Gleneagles Global Hospitals; 🇮🇳 Bangalore, KARNATAKA, India

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

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

Jasleen Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Lifepoint Multispecialty Hospital.; 🇮🇳 Pune, MAHARASHTRA, India

Nizams Institute of Medical Sciences; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Ramakrishna Mission Seva Pratisthan Vivekananda Institute of Medical Sciences; 🇮🇳 Kolkata, WEST BENGAL, India

Sanjay Gandhi Post Graduate Institute of Medical Sciences; 🇮🇳 Lucknow, UTTAR PRADESH, India

Seth G.S. Medical College and K.E.M Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Scroll for more (2 remaining)

Advanced Neurology & Superspecialty Hospital

🇮🇳Jaipur, RAJASTHAN, India

DrSunit Shah

Principal investigator

9829059370

sunitanu@yahoo.com