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CTRI Number  CTRI/2020/10/028718 [Registered on: 29/10/2020] Trial Registered Prospectively
Last Modified On: 10/09/2023
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 Study with perampanel as a treatment in children and adults with Lennox-Gastaut syndrome who have poorly controlled seizures. 
Scientific Title of Study   A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
E2007-G000-338 dated v11.0, 19 Nov 2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Rashmi Chitgupi 
Designation  Associate Director - Clinical Management 
Affiliation  PPD Pharmaceutical Development India Private Limited 
Address  PPD Pharmaceutical Development India Private Limited, 101, A Wing, Fulcrum, Hiranandani Business Park Sahar Road, Andheri East,Mumbai 101, A Wing, Fulcrum, Hiranandani Business Park
PPD Pharmaceutical Development India Private Limited, 101, A Wing, Fulcrum, Hiranandani Business Park Sahar Road, Andheri East,Mumbai 101, A Wing, Fulcrum, Hiranandani Business Park
Mumbai
MAHARASHTRA
400099
India 
Phone  912266022900  
Fax  912266022999  
Email  Rashmi.Chitgupi@ppdi.com  
 
Details of Contact Person
Public Query  
Name  Rashmi Chitgupi 
Designation  Associate Director - Clinical Management 
Affiliation  PPD Pharmaceutical Development India Private Limited 
Address  PPD Pharmaceutical Development India Private Limited, 101, A Wing, Fulcrum, Hiranandani Business Park Sahar Road, Andheri East,Mumbai 101, A Wing, Fulcrum, Hiranandani Business Park
PPD Pharmaceutical Development India Private Limited, 101, A Wing, Fulcrum, Hiranandani Business Park Sahar Road, Andheri East,Mumbai 101, A Wing, Fulcrum, Hiranandani Business Park
Mumbai
MAHARASHTRA
400099
India 
Phone  912266022900  
Fax  912266022999  
Email  Rashmi.Chitgupi@ppdi.com  
 
Source of Monetary or Material Support  
Eisai Ltd. European Knowledge Centre,Mosquito Way Hatfield Hertfordshire AL10 9SN United Kingdom 
 
Primary Sponsor  
Name  Eisai Ltd 
Address  European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN United Kingdom 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Belgium
Australia
Czech Republic
India
Japan
Republic of Korea
United States of America  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vinayan Puthenveettil   Amrita Institute of Medical Sciences and Research Centre (AIMS)  Division of Pediatric Neurology, Department of Neurology, Amrita Institute of Medical Sciences and Research Centre (AIMS), Ponekkara P.O, Kochi- 682 041
Ernakulam
KERALA 		 9447800303

vinayankp@aims.amrita.edu 
Dr Kavita Srivastava  Bharti Hospital, affiliated to Bharti Vidyapeeth Deemed to be University Medical College,  Pune- Satara Road, Pune- 411 043
Pune
MAHARASHTRA 		 9850825791

kavisri1970@gmail.com 
Dr Anaita Udwadia Hegde  Jaslok Hospital and Research Centre  Peddar Road, Mumbai- 400026,
Mumbai (Suburban)
MAHARASHTRA 		 9820186155

anaitahegde@gmail.com 
Dr Pradnya Gadgil  Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute  Rao Saheb Achutrao Patwardhan Marg, Four Bungalows, Andheri (West), Mumbai- 400 053
Mumbai
MAHARASHTRA 		 9820507577

pradnya_g@yahoo.com 
Dr Mona Gajre  Lokamanya Tilak Muncipal Medical College and General Hospital  Room no: 119,floor,college buidling, Department of Paediatrics, LTMMC&GH, Dr. Babasaheb Amedkar Road, Sion
Mumbai
MAHARASHTRA 		 9820407240

drmonagajre@gmail.com 
Dr Shankara Nellikunja   Mallikatta Neuro Center  Opposite Mallikata Circle, Kadri, Mangalore- 575 002,
Dakshina Kannada
KARNATAKA 		 9845080925

dr.shankaramnc@gmail.com 
Dr Ritesh Shah  Nirmal Hospital Pvt Ltd  Ring Road, Surat- 395 002, Gujarat, India
Surat
GUJARAT 		 9913187560

shah.drritesh@gmail.com 
Dr Suryaprabha Turaga  Nizams Institute of Medical Sciences  Panjagutta, Hyderabad:500082
Hyderabad
TELANGANA 		 09246589899

surmukh99@gmail.com 
Dr Siddharth Shah  Panchshil Hospital  Highway, Ramnagar, Sabarmati, Ahmedabad- 380 005
Ahmadabad
GUJARAT 		 9909960555

sidh909@hotmail.com 
Dr Praveen Kumar  Sir Ganga Ram Hospital  Rajinder Marg, New Delhi, Delhi 110 060
New Delhi
DELHI 		 9560190542

drpraveensingh31@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Ethics Committee, Jaslok Hospital and Research Centre  Approved 
Institutional Ethics Committee, Amrita Institute of Medical Sciences and Research Centre (AIMS)  Submittted/Under Review 
Institutional Ethics Committee, Bharti Vidyapeeth Deemed to be University  Approved 
Institutional Ethics Committee, Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute  Submittted/Under Review 
Institutional Ethics Committee-Human Research  Submittted/Under Review 
Mangala Institutional Ethics Committee  Approved 
Nirmal Hospital Pvt Ltd Ethics Committee  Approved 
Nizams Institute of Medical Sciences  Submittted/Under Review 
Panchshil Institutional Ethics Committee  Approved 
Sir Ganga Ram Hospital Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G408||Other epilepsy and recurrent seizures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Perampanel  Single daily dose administration of perampanel given as multiple oral 2-mg tablets to give a dose of 2 mg/day to 8 mg/day (randomization phase) or up to 12 mg/day (Extension A and Extension B, except in Japan where the maximum dose remains as 8 mg/day).  
Comparator Agent  Placebo  Single daily dose administration of Placebo matched to perampanel 2-mg tablets Placebo matched to perampanel oral suspension 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Subjects must have diagnosis of Lennox-Gastaut Syndrome (LGS)
2. At least 2 years old at the time of consent/assent
3. Age of LGS onset must be <11 years old
4. Must have an average of at least 2 drop seizures per week in the 4-week Baseline Period
5. Must be taking 1 to 4 concomitant anti-epileptic drugs (AEDs) at a stable dose for at least 30 days before Visit 1
 
 
ExclusionCriteria 
Details  1. Presence of progressive neurological disease
2. Presence of drop seizure clusters where individual seizures cannot be reliably counted
3. Prior treatment with perampanel with discontinuation due to safety issues related to perampanel or recent treatment with perampanel within 30 days before Screening
4. Scheduled for epilepsy-related surgery or other surgery during the study
5. Status epilepticus within 12 weeks before Screening
6. Current use of felbamate of less than 1 year, or with dose changes within 60 days before Screening, or history of hematological/hepatic function test abnormalities or other indication of hepatic/bone marrow dysfunction while receiving felbamate.
7. Current or recent use of vigabatrin within 5 months of Screening, or history of vigabatrin-associated clinically significant abnormality in an automated visual perimetry test
8. Intermittent use of benzodiazepine of more than 4 single administrations in the month before Screening
9. Psychotic disorders or unstable recurrent affective disorders evident by use of antipsychotics or prior suicide attempts within approximately the last 2 years
10. Use of AEDs not recommended by Epilepsy Treatment Guidelines for use in LGS
11. Any suicidal ideation with intent with or without a plan within 6 months before Randomization Visit
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To demonstrate that perampanel given as adjunctive antiepileptic treatment is superior to placebo in reducing the incidence of drop seizures in subjects with inadequately controlled seizures associated with LGS  Median percent change in drop seizure frequency per 28 days 
 
Secondary Outcome  
Outcome  TimePoints 
To demonstrate that perampanel adjunctive treatment is superior to placebo in reducing the incidence of all seizures in subjects with inadequately controlled seizures associated with LGS  Median percent change in total seizure frequency per 28 days 
To demonstrate that perampanel adjunctive treatment is superior to placebo in the 50%, 75%, and 100% responder rates for drop seizures in subjects with inadequately controlled seizures associated with LGS  50% responder rate for drop seizures
Others: 75% and 100% responder rates for drop seizures
 
To demonstrate that perampanel adjunctive treatment is superior to placebo in the 50%, 75%, and 100% responder rates for total seizures in subjects with inadequately controlled seizures associated with LGS  50% responder rate for total seizures
Others: 75% and 100% responder rates for total seizures
 
To demonstrate that perampanel adjunctive treatment is superior to placebo in reducing the incidence of non-drop seizures in subjects with inadequately controlled seizures associated with LGS  Median percent change in non-drop seizure frequency per 28 days 
To evaluate the 50%, 75%, and 100% responder rates in non-drop seizure frequency  50%, 75%, and 100% responder rates for non-drop seizures 
To evaluate physicians’ global evaluation of subjects’ overall changes in symptoms Physicians’ global evaluation of the subject’s overall changes in symptoms  Physicians’ global evaluation of the subject’s overall changes in symptoms 
To evaluate the safety of perampanel relative to placebo as adjunctive therapy in subjects with inadequately controlled seizures associated with LGS  Incidence of AEs and SAEs, changes in clinical laboratory values, and vital signs 
To evaluate the pharmacokinetics (PK) and the pharmacokinetic/pharmacodynamic (PK/PD) relationships of perampanel as adjunctive therapy in subjects with inadequately controlled seizures associated with LGS  Model-derived average perampanel concentrations at steady state (Cav,ss) 
 
Target Sample Size   Total Sample Size="142"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   30/10/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  13/12/2016 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="4"
Days="13" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This will be a multicenter, double-blind, randomized, placebo-controlled, parallel-group study of perampanel as adjunctive therapy in subjects with inadequately controlled seizures associated with LGS. The study will consist of 3 phases: Prerandomization (4- to 8-week Screening/Baseline Period), Randomization (6-week Titration, 12-week Maintenance, and 4-week Follow-up, only for subjects not entering into Extension A), and Extension (Extension A and Extension B).  Extension A will consist of 6-week blinded Conversion Period, 46-week Maintenance Period, and 4-week Follow-up (for those subjects not entering into Extension B).  Extension B is planned to be implemented in Japan and in countries where an Extended Access Program cannot be implemented or has not yet been implemented.

Following the Screening/Baseline Period, eligible subjects will be randomized to receive perampanel or placebo in a 1:1 ratio.  During the Randomization Phase, perampanel (or matching placebo) will be administered once daily at a starting dose of 2 mg and up-titrations to a maximum target dose of 8 mg according to individual tolerability and efficacy.  During Extension A, subjects in the perampanel group during the Randomization Phase will continue with perampanel treatment at the same dose received at the end of the Randomization Phase.  Subjects in the placebo group during the Randomization Phase will begin treatment with perampanel in a blinded manner starting at 2 mg/day and then up-titrated to a target dose of 8 mg/day.  After the double-blind Conversion Period, further up-titrations up to 12 mg/day (except in Japan, where the maximum allowed dose remains at 8 mg/day) is allowed at the discretion of the investigator. Addition, deletion, and dose changes to the concomitant AEDs are allowed during Extension Maintenance Period.

 
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