| CTRI Number |
CTRI/2012/08/002859 [Registered on: 06/08/2012] Trial Registered Prospectively |
| Last Modified On: |
05/03/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A research study to find out if people with Primary Generalized
Tonic-Clonic Seizures (epilepsy), by taking perampanel in addition to their normal
epilepsy medicine(s), have fewer seizures and feel better. |
|
Scientific Title of Study
|
A Double-blind, Randomized, Placebo-controlled, Multicenter, Parallelgroup
Study with an Open-label Extension Phase to Evaluate the Efficacy
and Safety of Adjunctive Perampanel in Primary Generalized Tonic-Clonic
Seizures. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| E2007-G000-332 (dated 15 Nov 2013, v5.0 (per Amendment 03)) |
Protocol Number |
| NCT01393743 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Arun Sundriyal |
| Designation |
Associate Director - Clinical Management |
| Affiliation |
PPD Pharmaceutical Development India Pvt. Ltd. |
| Address |
PPD Pharmaceutical Development India Pvt. Ltd., Vatika City Point,
11th Floor,Sector 25, Mehrauli Gurgaon Road, Gurgaon
Gurgaon
HARYANA
122002
India |
| Phone |
911244739903 |
| Fax |
911244739999 |
| Email |
Arun.Sundriyal@ppdi.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Arun Sundriyal |
| Designation |
Associate Director - Clinical Management |
| Affiliation |
PPD Pharmaceutical Development India Pvt. Ltd. |
| Address |
PPD Pharmaceutical Development India Pvt. Ltd., Vatika City Point,
11th Floor,Sector 25, Mehrauli Gurgaon Road, Gurgaon
Gurgaon
HARYANA
122002
India |
| Phone |
911244739903 |
| Fax |
911244739999 |
| Email |
Arun.Sundriyal@ppdi.com |
|
|
Source of Monetary or Material Support
|
| Eisai Limited, European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN
United Kingdom |
|
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Primary Sponsor
|
| Name |
Eisai Limited |
| Address |
Eisai Limited, European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN, United Kingdom |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| PPD Pharmaceutical Development India Pvt Ltd |
01-Dynasty B-Wing (Kanakia Spaces)
Andheri-Kurla Road, Andheri East, Mumbai-400059, India |
|
Countries of Recruitment
Modification(s)
|
Australia
Austria
China
Czech Republic
Greece
Hungary
India
Japan
Latvia
Netherlands
Poland
Republic of Korea
Serbia
United States of America
Estonia
Spain
Tajikistan |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sita Jayalakshmi Sattaluri |
Krishna Institute of Medical Sciences |
Department of Neurology, #1-8-31/1,Minister Road, Seccunderabad Hyderabad - 500003, Andhra Pradesh, India
Hyderabad
ANDHRA PRADESH |
914044885452
sita_js@hotmail.com |
| Dr Srinivasa R |
M. S. Ramaiah Medical College and Hospitals |
M. S. Ramaiah Medical College and Hospitals,MSRIT Post, New BEL Road,Bangalore - 560054 ,Karnataka,India AND M.S.Ramaiah Clinical Research Centre,First Floor, M.S.Ramaiah Learning Centre,Gate No:No.4,Gnanagangothri Campus,MSRIT Post,New BEL Road,Bangalore-560054, Karnataka,India
Bangalore
KARNATAKA |
918022183125
drrsrinivasa@hotmail.com |
| Dr Shankara Nellikunja |
Mallikatta Neuro Center |
Opp. Mallikatta Circle, Kadri,
Mangalore – 575 002, Karnataka, India
Udupi
KARNATAKA |
918242444933
shankarmnl@hotmail.com |
| Dr Atul Agarwal |
Neurology Clinic |
55 Ravindra Palli, Faizabad Road, Lucknow – 226016, Uttar Pradesh, India.
Lucknow
UTTAR PRADESH |
919415175001
dratul1@rediffmail.com |
| Dr Anshu Rohatgi |
Sir Ganga Ram Hospital |
Department of Neurology, 4th Floor, Rajinder Nagar, New Delhi – 110 060, India.
New Delhi
DELHI |
919810159046
rohatgianshu@yahoo.com |
| Dr Vikram Sharma |
St. Theresa’s General Hospital |
Dept of Neurology,
Erragadda, Sanath Nagar, Hyderabad – 500 018
Andhra Pradesh, India.
Hyderabad
ANDHRA PRADESH |
914023814556
drvikramsharma@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee - Krishna Institute of Medical Sciences, Hyderabad (Dr. Sita Sattaluri) |
Approved |
| Ethics Committee - M S Ramaiah Medical College and Hospitals, Bangalore (Dr R Srinivasa) |
Approved |
| Ethics Committee, Sir Ganga Ram Hospital, New Delhi (Dr. Anshu Rohatgi) |
Approved |
| Ethics Committee, St. Theresas Hospital, Hyderabad (Dr. Vikram Sharma) |
Approved |
| Lucknow Independent Ethics Committee, Lucknow (Dr Atul Agarwal - Neurology Clinic) |
Approved |
| Mallikatta Ethical Committee Mangalore (Dr Shankara Nellikunja - Mallikatta Neuro Centre) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Primary Generalized Tonic-Clonic Seizures (Epilepsy), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Experimental: Perampanel |
Drug: perampanel
up to 8 mg, oral tablet, once daily (55 weeks) |
| Comparator Agent |
Placebo Comparator: Placebo |
Drug: Placebo comparator
oral tablet, once daily (17 Weeks) |
|
Inclusion Criteria
Modification(s)
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinical diagnosis of PGTC seizures (with or without other subtypes of primary generalized seizures) and experiencing more than or equal to 3 PGTC seizures during the 8-week period prior to randomization.
2. Have had a routine electroencephalogram (EEG) prior to or during the Baseline Period with electroencephalographic features consistent with primary generalized epilepsy; other concomitant anomaly should be explained by adequate past medical history
3. On a fixed dose of one to a maximum of three concomitant antiepileptic drugs (AEDs) for a minimum of 30 days prior to Baseline; only one inducer AED (i.e., carbamazepine, oxcarbazepine, or phenytoin) out of the maximum of three AEDs will be allowed
4. A vagal nerve stimulator (VNS) will be allowed, but it must have been implanted more than or equal to 5 months prior to Baseline (stimulator parameters can not be changed for 30 days prior to Baseline and for the duration of the study).
5. Have had a computed tomography (CT) or magnetic resonance imaging (MRI) within the last 10 years (for adults) and 5 years (for adolescents) that ruled out a progressive cause of epilepsy
6. A ketogenic diet will be allowed as long as the subject has been on this diet for 5 weeks prior to randomization
|
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| ExclusionCriteria |
| Details |
1. A history of status epilepticus that required hospitalization within 12 months prior to Baseline
2.Seizure clusters where individual seizures cannot be counted
3.A history of psychogenic seizures
4.Concomitant diagnosis of Partial Onset Seizures (POS)
5.Progressive neurological disease
6.Clinical diagnosis of Lennox-Gastaut syndrome
7.If felbamate is used as a concomitant AED, subjects must be on felbamate for at least 2 years, with a stable dose for 60 days prior to Baseline. They must not have a history of white blood cell (WBC) count below less than or equal to 2500/microL (2.50 1E+09/L), platelets less than 100,000/microL, liver function tests (LFTs) more than 3 times the upper limit of normal (ULN), or other indication of hepatic or bone marrow dysfunction while receiving felbamate.
8.Concomitant use of vigabatrin: Subjects who took vigabatrin in the past must be discontinued for approximately 5 months prior to Baseline, and must have documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in an automated visual perimetry test
9.Concomitant use of barbiturates (except for seizure control indication) within 30 days prior to Baseline
10.Use of intermittent rescue benzodiazepines (i.e., one to two doses over a 24-hour period considered one-time rescue) two or more times within the 30 days prior to Baseline |
|
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Method of Generating Random Sequence
|
Stratified block randomization |
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Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percent change from baseline in PGTC seizure frequency per 28 days |
From baseline over the Titration and Maintenance Periods (17 weeks) |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Responder Rate for other subtypes of primary generalized seizure frequency (i.e, myoclonic, absence and all seizures) per 28 days |
Maintenance Period relative to baseline (17 weeks) |
|
|
Target Sample Size
|
Total Sample Size="164"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "138"
Final Enrollment numbers achieved (India)="13" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
24/09/2012 |
| Date of Study Completion (India) |
08/09/2015 |
| Date of First Enrollment (Global) |
07/09/2011 |
| Date of Study Completion (Global) |
16/10/2015 |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
|
This study is designed to evaluate the efficacy, safety, and pharmacokinetics (PK) of perampanel on Primary Generalized Tonic Clonic (PGTC) seizure frequency in adolescents and adults maintained on one to a maximum of three stable antiepileptic drugs. |