| CTRI Number |
CTRI/2019/01/016844 [Registered on: 02/01/2019] Trial Registered Prospectively |
| Last Modified On: |
19/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Post Marketing Study of Perampanel in Patients with Epilepsy |
|
Scientific Title of Study
|
A Prospective, Multicenter, Post-marketing Surveillance to Assess Safety & Efficacy of Perampanel in Indian Patients as an Adjunctive Treatment inPartial Onset Seizures with or Without Secondary Generalized Seizures in Patients with Epilepsy Aged 12 years or older. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| File No: 12-64/13-DC |
DCGI |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajaykumar B Malle |
| Designation |
General Manager-Clinical Trials |
| Affiliation |
Accutest Research Laboratories (I) Pvt.Ltd. |
| Address |
A-77, Khairne MIDC, TTC Industrial Area,
Khairne, Navi Mumbai
Mumbai
MAHARASHTRA
400709
India |
| Phone |
02227780718 |
| Fax |
02227780720 |
| Email |
ajay.malle@accutestglobal.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajaykumar B Malle |
| Designation |
General Manager-Clinical Trials |
| Affiliation |
Accutest Research Laboratories (I) Pvt.Ltd. |
| Address |
A-77, Khairne MIDC, TTC Industrial Area,
Khairne, Navi Mumbai
MAHARASHTRA
400709
India |
| Phone |
02227780718 |
| Fax |
02227780720 |
| Email |
ajay.malle@accutestglobal.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Seema Chaurasia |
| Designation |
Manager-Clinical Trials |
| Affiliation |
Accutest Research Laboratories (I) Pvt.Ltd. |
| Address |
A-77, Khairne MIDC, TTC Industrial Area,
Khairne, Navi Mumbai
Mumbai
MAHARASHTRA
400709
India |
| Phone |
02227780718 |
| Fax |
02227780720 |
| Email |
Seema.Chaurasia@accutestglobal.com |
|
|
Source of Monetary or Material Support
|
| Eisai Pharmaceutical India Limited
Ist floor, B- Wing, Marwah Center,
KrishanlalMarwah Marg,
Andheri (E)-Mumbai-400072 |
|
|
Primary Sponsor
|
| Name |
Eisai Pharmaceutical India Limited |
| Address |
Ist floor, B- Wing, Marwah Center,
KrishanlalMarwah Marg,
Andheri (E)-Mumbai-400072 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSunit Shah |
Advanced Neurology & Superspecialty Hospital |
D-358, Brain tower, Near Gaurav Tower, Malviya Nagar
Jaipur
RAJASTHAN |
9829059370
0141-2729204
sunitanu@yahoo.com |
| Dr Madhusudhan BK |
BGS Gleneagles Global Hospitals |
67, Uttarahalli Road, Fort Kengeri, Bengaluru, Karnataka 560060
Bangalore
KARNATAKA |
9902078244
drmadhubk@gmail.com |
| Dr Rahul Kulkarni |
Deenanath Mangeshkar Hospital and Research Centre |
S S Building, Neurology Research Department, Erandwane, Pune- 411004, Maharashtra
Pune
MAHARASHTRA |
9822012588
020-49153242
rahulneuro@gmail.com |
| Dr Prafulla Keshaorao Shembalkar |
Getwell Hospital and Research Institute |
Department of Neurology, 20/1, Dr. Khare Marg, Dhantoli, Nagpur – 440012, Maharashtra.
Nagpur
MAHARASHTRA |
9096050839
0712-6645017
pkshembalkar@hotmail.com |
| Dr Sanjay Ramteke |
Jasleen Hospital |
Brain Clinic, Opp. Big Bazar, Panchsheel Square, Dhantoli, Nagpur- 440012
Maharashtra.
Nagpur
MAHARASHTRA |
9890332286
0712-2421209
ssrt95@yahoo.co.in |
| Dr Gunjkar Jaykumar Digambar |
Lifepoint Multispecialty Hospital. |
3rd Floor, Clinical Research Department, 145/1, Mumbai Bangalore Higwhay, Near Hotel Sayaji, Wakad Pune MAHARASHTRAÂ
Pune
MAHARASHTRA |
9767092120
020-66434399
gunjkar.jaykumar118@gmail.com |
| Dr Shaik Afshan Jabeen |
Nizams Institute of Medical Sciences |
Department of Neurology
Millennium Block, Punjagutta, Hyderabad, Telangana 500082.
Hyderabad
ANDHRA PRADESH |
9704822022
9140-23350619
drjabeennims@gmail.com |
| Dr Barun kumar Sen |
Ramakrishna Mission Seva Pratisthan Vivekananda Institute of Medical Sciences |
Department of Neurology, 99,Sarat Bose Road, Kolkata-700026, West Bengal
Kolkata
WEST BENGAL |
9231509099
drbarunsen@gmail.com |
| Dr Ushakant Mishra |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Department of Neurology Raebareli Road, Lucknow- 226014, Uttar Pradesh.
Lucknow
UTTAR PRADESH |
8004904627
91-05222668811
drumisra@rediffmail.com |
| Dr Ravat Sangeeta Hasmukh |
Seth G.S. Medical College and K.E.M Hospital |
Department of Neurology, 2nd Floor, Ward No. 10,Old Building, Acharya Donde Marg, Parel, Mumbai-400012
Mumbai
MAHARASHTRA |
9820310850
022-24164206
ravatsh@yahoo.com |
| Dr Anshu Rohatgi |
Sir Ganga Ram Hospital. |
Sir Ganga Ram Hospital Marg , Rajinder Nagar,
New Delhi
DELHI |
9810159046
011-45041726
rohatgianshu@yahoo.com |
| Dr Pahari Ghosh |
Sri Aurobindo Seva Kendra |
Neurology Department,1 H Gariahat road (South), Jodhpur Park, Kolkata -700068
West Bengal
Kolkata
WEST BENGAL |
9831023296
33-2499-0059
ghosh.pahari@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Getwell Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee - Ramakrishna Mission Seva Pratisthan Vivekananda Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, Deenanath Mangeshkar Hospital and Research Center |
Approved |
| Institutional Ethics Committee, Seth G.S.Medical College and K.E.M. Hospital |
Approved |
| Institutional Ethics Committee-BGS Global Hospital |
Approved |
| Jasleen Hospitals Ethics Committee |
Approved |
| LPR Ethics Committee, Lifepoint Multispeciality Hospital |
Approved |
| NIMS Institutional Ethics Committee |
Approved |
| Sanjay Gandhi Post Graduate Institute of Medical Sciences, Institutional Ethics Committee |
Approved |
| Sir Ganga Ram Hospital Ethics Committee |
Approved |
| Somex Research & Health Ethics Committee |
Approved |
| The Ethics Committee of Shri Aurobindo Seva Kendra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G401||Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Perampanel (Fycompa) |
Perampanel (Fycompa) Tablet. 2mg/4mg/6mg/8mg/10mg/12mg Once a day for 6 months. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
12.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. 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.
3. Patients who provide informed consent to the treating physician. |
|
| ExclusionCriteria |
| Details |
1. Participation in another study involving administration of an investigational drug or
device whilst participating in this observational study
2. Hypersensitivity [allergic] to perampanel |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the safety of perampanel in the treatment of partial onset seizures in patients
of age 12 years and older with epilepsy. |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
ô€¸ To assess the responder rate (50% seizure frequency reduction) with perampanel as
adjunctive treatment of partial onset seizures in patients of age 12 years and older with
epilepsy
ô€¸ To evaluate proportion of seizure free patients at the end of 3-months, and 6-months
and last 3 months during the treatment period. |
3 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Post Marketing Surveillance |
Date of First Enrollment (India)
Modification(s)
|
18/02/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |