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CTRI Number  CTRI/2019/05/018997 [Registered on: 08/05/2019] Trial Registered Prospectively
Last Modified On: 17/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of topiramate versus propranolol in preventive treatment of chronic migraine 
Scientific Title of Study   A randomized double blind controlled trial of Topiramate versus Propranolol in the prevention of chronic migraine: TOP-PRO STUDY 
Trial Acronym  TOP-PRO STUDY 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  LUV BANSAL 
Designation  DM NEUROLOGY RESIDENT 
Affiliation  GIPMER 
Address  DEPARTMENT OF NEUROLOGY GIPMER DELHI
DELHI
New Delhi
DELHI
110002
India 
Phone  9718980551  
Fax    
Email  luvbansal30@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR DEBASHISH CHOWDHURY 
Designation  HOD AND DIRECTOR PROFESSOR 
Affiliation  GIPMER 
Address  DEPARTMENT OF NEUROLOGY GIPMER DELHI
DELHI
New Delhi
DELHI
110002
India 
Phone  9718599306  
Fax    
Email  debashishchowdhury@hotmail.com  
 
Details of Contact Person
Public Query  
Name  LUV BANSAL 
Designation  DM NEUROLOGY RESIDENT 
Affiliation  GIPMER 
Address  DEPARTMENT OF NEUROLOGY GIPMER DELHI
DELHI
New Delhi
DELHI
110002
India 
Phone  9718980551  
Fax    
Email  luvbansal30@gmail.com  
 
Source of Monetary or Material Support  
GIPMER GB PANT INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 
LUV BANSAL  GB PANT HOSPITAL  HEADACHE CLINIC AND NEUROLOGY OPD, MONDAY, WEDNESDAY, THURSDAY, ROOM NO 328, DEPARTMENT OF NEUROLOGY, GB PANT HOSPITAL
New Delhi
DELHI 		 9718980551

luvbansal30@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, MAMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G437||Chronic migraine without aura, (2) ICD-10 Condition: G438||Other migraine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Propranolol 160mg  Propranolol will be given while raising the dose from 40 mg to 160 mg in weekly increments and then administerd for 20 weeks and finally tapered over next 4 weeks to the minimum required dose depending upon the effect. Various parameters like VAS, MIDAS, PHQ etc will be done to study the efficacy of drug on Chronic migraine patients. 
Comparator Agent  TOPIRAMATE 100mg  Topiramate will be given while raising the dose from 25 mg to 100 mg in weekly increments and then administered for 20 weeks and finally tapered over next 4 weeks to the minimum required dose depending upon the effect. Various parameters like VAS, MIDAS, PHQ etc will be done to study the efficacy of drug on Chronic migraine patients. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients aged 18-65 years, either male or female who fulfills the diagnostic criteria laid down by ICHD 3 for Chronic migraine and not on any prophylactic treatment. 
 
ExclusionCriteria 
Details  All patients with a clinical phenotype of CM but on further investigation, found to have a
secondary cause for their headaches will be excluded. Pregnant women, patient with known
allergies against propranolol and/or topiramate, patients with history of bronchial asthma,
Chronic obstructive pulmonary disease (COPD), diabetes, bradycardia or heart blocks,
congestive heart failure (CHF), glaucoma, renal stones, dementia, psychosis and severe
depression shall be excluded from the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary endpoints
1. Change in migraine days per 28 days (Migraine day is defined as a calendar day
when the patient reported ≥4 continuous hours of headache meeting ICHD 3 criteria
for migraine) 		 It will be assessed at the baseline and then after 20 weeks of drug administration i.e at week 24 of trial. 
 
Secondary Outcome  
Outcome  TimePoints 
A. Frequency parameters
1. Change in headache days per 28 days (Headache day is defined as a calendar day
[00:00 to 23:59] when the patient reported ≥4 continuous hours of headache episode
in the diary)
2. More than 50% reduction in headache days compared to baseline.
3. Migraine free days per month.
4. Number of days and dosage of drug taken to abort the acute attacks
(analgesics/triptans/ergotamines) 		 It will be assessed at the baseline and then after 20 weeks of drug administration i.e at week 24 of trial. 
B. Severity parameters
1. Change in average Visual analogue scale (VAS) score at the end of each month. 		 It will be assessed at the baseline and then after 20 weeks of drug administration i.e at week 24 of trial. 
C. Adverse events  It will be assessed at the baseline and then after 20 weeks of drug administration i.e at week 24 of trial. 
D. Impact on headache disorder and associated disability
1. Headache Impact Test (HIT)
2. Migraine Disability Assessment (MIDAS)
3. Change in migraine specific quality of life (MSQOL)
4. Global impression of change  		 It will be assessed at the baseline and then after 20 weeks of drug administration i.e at week 24 of trial. 
 
Target Sample Size   Total Sample Size="270"
Sample Size from India="270" 
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/ Phase 4 
Date of First Enrollment (India)   10/05/2019 
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)
Modification(s)  		 Not Applicable 
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)?  

Brief Summary   Chronic migraine is a highly debilitating condition and the only FDA approved drug for its treatment is Botulinum toxin which is very costly and involves multiple injections over head and face. Recent studies have shown Topiramate to be effective in Chronic migraine. Propranolol is a safe and effective drug for episodic migraine and is cheaper than most other options. It has not been studied properly in chronic migraine patients however, in clinical practice it is widely used across various migraine groups with good effects. This study aims to study the effect of Propranolol in dose of 160 mg versus Topiramate 100 mg in a non inferiority design to establish its efficacy and safety. Our hypothesis is that Propranolol is similarly effective as Topiramate in chronic migraine patients and will provide a cheaper and time established safe and effective medication for sufferers of chronic migraine.    
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