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CTRI Number  CTRI/2024/08/072081 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 04/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing two Medications in Steroid and Vigabatrin Resistant West Syndrome: Clonazepam versus Nitrazepam 
Scientific Title of Study   A Randomized Control Trial on effectiveness of Clonazepam Versus Nitrazepam after failure of Steroids and Vigabatrin in Infantile Epileptic Spasm Syndrome. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vidya 
Designation  PAEDIATRIC MEDICINE RESIDENT 
Affiliation  INDIRA GANDHI INSTITUE OF CHILD HEALTH , 
Address  Indira Gandhi Institute of Child Health , 1st Block, Siddapura, Jayanagar, Bengaluru
Neurology OPD Indira Gandhi Institute of Child Health , 1st Block, Siddapura, Jayanagar, Bengaluru
Bangalore
KARNATAKA
560029
India 
Phone  8971850835  
Fax    
Email  vidya.naik443@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Naveen Kumar P 
Designation  Assistant Professor of Paediatric  
Affiliation  INDIRA GANDHI INSTITUE OF CHILD HEALTH , 
Address  OPD Indira Gandhi Institute of Child Health, 1st Block, Siddapura, Jayanagar, Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9535212556  
Fax    
Email  drknvraju08@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vidya 
Designation  PAEDIATRIC MEDICINE RESIDENT 
Affiliation  INDIRA GANDHI INSTITUE OF CHILD HEALTH , 
Address  Indira Gandhi Institute of Child Health, 1st Block, Siddapura, Jayanagar, Bengaluru
Neurology Opd Indira Gandhi Institute of Child Health, 1st Block, Siddapura, Jayanagar, Bengaluru

KARNATAKA
560029
India 
Phone  8971850835  
Fax    
Email  vidya.naik443@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi Institute of Child Health, 1st Block, Siddapura, Jayanagar Bengaluru 560029 
 
Primary Sponsor  
Name  INDIRA GANDHI INSTITUE OF CHILD HEALTH 
Address  1st Block, Siddapura, Jayanagar Bengaluru-560029 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR Vidya Subhas Naik  Indira Gandhi Institute of Child Health  Neurology OPD and In patient Department 2nd floor,Indira Gandhi Institute of Child Health, Dharmaram Post near NIMHANS Jayanagar Bengaluru-560029 BENGALURU, KARNATAKA
Bangalore
KARNATAKA 		 8971850835

vidya.naik443@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IGICH INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G403||Generalized idiopathic epilepsy and epileptic syndromes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CLONAZEPAM  Drug therapy with Clonazepam Dose:0.01-0.5mg/kg/day Duration: 14 days initially, if responded then to continue for 6 months. 
Intervention  NITRAZEPAM  Drug therapy with Nitrazepam Dose: 0.5-3mg/kg/day Duration:14 days initially and then assess if responded then to continue for 6 months.  
 
Inclusion Criteria  
Age From  3.00 Month(s)
Age To  3.00 Year(s)
Gender  Both 
Details  Children diagnosed with west syndrome not responding to steroids and Vigabatrin. 
 
ExclusionCriteria 
Details  Children in whom Benzodiazepines are contraindicated.
Children inncompletely treated or partially treated with First Line Drugs 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To asses the Response in participants in term of reduction in number of spasms  To asses the Response in participants in term of reduction in number of spasms after 2 weeks of Starting the Drug Therapy then follow up after 1motn,3month and 6month. 
 
Secondary Outcome  
Outcome  TimePoints 
Developmental improvement in all the developmental milestones.  At the end of 6 months of study 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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   N/A 
Date of First Enrollment (India)   16/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Infantile Epileptic Spasm Syndrome which is Characterised by Epileptic spasms,  Developmental Delay and Hypsarrhythmia or its varient on EEG,  is a difficult to treat syndrome.The infantile spasms are initially treated with Steroids(ACTH or Prednisolone) and Vigabatrin. However not all cases respond to the first line therapy .Hence second line therapy with Benzodiazepines and other drugs are used to treat these resistant cases. But there is paucity of trialsand literature on the Second line therapy more so on Benzodiazepines. Hence this study was undertaken to compare effectiveness of two commonly used Benzodiazepines Nitrazepam and Clonazepam in Infantile Epileptic Spasm Syndrome. 
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