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CTRI Number  CTRI/2020/07/026417 [Registered on: 07/07/2020] Trial Registered Prospectively
Last Modified On: 02/07/2020
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A PMS Study of fixed dose combination of Propranolol Hydrochloride plus Flunarizine in the prophylaxis of migraine without aura. 
Scientific Title of Study   A post marketing, open label, multicentre study to evaluate the safety and efficacy of Fixed Dose Combination of Propranolol Hydrochloride 40 mg plus Flunarizine 5 mg and Fixed Dose Combination of Propranolol Hydrochloride 40 mg plus Flunarizine 10 mg in the prophylaxis of migraine without aura. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
BRADPL/PHF/PMS/05/19; Version 2.0; Date: 10 Dec 2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr R S Raman 
Designation  Consultant 
Affiliation  Maharaja Agrasen Hospital 
Address  Department of Medicine Maharaja Agrasen Hospital West Punjabi Bagh New Delhi

West
DELHI
110026
India 
Phone  01140777777  
Fax    
Email  dr.rs.raman.2005@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aditi Datta 
Designation  Managing Director 
Affiliation  Biosite Research Private Limited 
Address  Building No 740 2nd Floor 14th Main Road Kumarswamy Layout Stage 1 Bangalore

Bangalore
KARNATAKA
560078
India 
Phone  08026667707  
Fax  08026667707  
Email  aditi.datta@biositeindia.com  
 
Details of Contact Person
Public Query  
Name  Dr Aditi Datta 
Designation  Managing Director 
Affiliation  Biosite Research Private Limited 
Address  Building No 740 2nd Floor 14th Main Road Kumarswamy Layout Stage 1 Bangalore

Bangalore
KARNATAKA
560078
India 
Phone  08026667707  
Fax  08026667707  
Email  aditi.datta@biositeindia.com  
 
Source of Monetary or Material Support  
AKUMS DRUGS & PHARMACEUTICALS LTD 304, Mohan Place,Local Shopping Complex,Block - C, Saraswati Vihar,New Delhi - 110034  
 
Primary Sponsor  
Name  AKUMS DRUGS PHARMACEUTICALS LTD 
Address  304, Mohan Place,Local Shopping Complex,Block - C, Saraswati Vihar,New Delhi - 110034  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abdul Qavi  Dr Ram Manohar Lohia Institue of Medical sciences  Vibhutikhanda Gomti Nagar Lucknow 226010
Lucknow
UTTAR PRADESH 		 7376128123

drqavi2008@gmail.com 
Dr Manoj Gupta  Health Point Hospital  21 Prannath Pandit Street Opp Lansdown Padmapukur Kolkata 700020
Kolkata
WEST BENGAL 		 9599038676

manojsrmc@gmail.com 
Dr Harish Gupta  King George’s Medical University (KGMU)  King Georges Medical University, Chowk, Lucknow 226003
Lucknow
UTTAR PRADESH 		 8299844471

drharishgupta170@gmail.com 
Dr K Shiva Raju  Krishna Institute of Medical Sciences  Department of Internal Medicine 1-8-31/1, Minister Road, Secunderabad 500003
Hyderabad
TELANGANA 		 9848510401

shivaraju.doctor@gmail.com 
Dr R S Raman  Maharaja Agrsen Hospital  West Punjabi Bagh New Delhi
West
DELHI 		 01140777777

dr.rs.raman.2005@gmail.com 
Dr Nikhil P Chougule  Om Sai Onco Surgery Multispeciality Center  R.S.No 457/10C Dr LAD Colony Sugar Mill Corner Main Road Kolhapur 416006
Kolhapur
MAHARASHTRA 		 9890533993

n_chougule@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Dr Abdul Qavi, Institutional Ethics Committee, Dr Ram Manohar Lohia Institute of Medical Sciences  Submittted/Under Review 
Dr R S Raman,Institutional Ethics Committee, Maharaja Agrasen Hospital  Approved 
Health Point Ethics Committee, Health Point Hospital  Approved 
Institutional Ethics Committee, King George’s Medical University (KGMU)  Submittted/Under Review 
KIMS Ethics Committee, Krishna Institute of Medical Sciences  Submittted/Under Review 
Om Sai Onco Institutional Ethics Committee, Om Sai Onco Surgery Center  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G430||Migraine without aura,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fixed Dose Combination of Propranolol Hydrochloride IP 40 mg (as sustained release) and Flunarizine 10 mg.  One uncoated bilayered tablet containing propranolol hydrochloride IP 40 mg (as sustained release) and flunarizine 10 mg to be taken once daily at night. 
Intervention  Fixed Dose Combination of Propranolol Hydrochloride IP 40 mg (as sustained release) and Flunarizine 5 mg  One uncoated bilayered tablet containing propranolol hydrochloride IP 40 mg (as sustained release) and flunarizine 5 mg to be taken once daily at night 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of either sex, between the ages of 18 to 65 years.
2. Patients with history of migraine without aura for at least 3 months prior to evaluation of study as per International Classification of Headache Disorders (ICHD)
3. Patients experience 2-6 migraine attacks per month, but not more than 15 headache days per month.
4. Patients willing to sign Informed Consent Form.
 
 
ExclusionCriteria 
Details  1. Patients have more than 15 headache days per month or less than 2 migraine attacks per month.
2. Pregnant women or nursing mothers.
3. Women of child-bearing potential & all men not willing to follow a reliable & effective birth control measure during the course of the study & at least 3 months after the last visit.
4. Patients have commenced any form of migraine prophylactic therapy within 1 month preceding the trial.
5. Patients need antidepressant medicines.
6. Patient’s headache attacks are associated with or attributable to an identifiable cause, such as: premenstrual period; a disease of eye, ear or nose; a neurological disease or psychosis.
7. Patients with known history of bronchial asthma.
8. Patients with known history of dyslipidemia.
9. Patients with diabetes mellitus, uncontrolled hypertension, epilepsy or other co-existing disease for which they require a concomitant medication with anti-migraine activity, such as: beta-blocker, calcium channel blockers, antidepressants or antiepileptics.
10. Unlikely to maintain a headache diary, comply with the medication or be regular in follow-up visits.
11. Any serious disease that would interfere with the compliance to the study protocol. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Frequency of migraine attacks.
2. Intensity of migraine attacks.
3. Migraine disability assessed by Migraine Disability Assessment (MIDAS) scale. 		 Day 01; Day 30±2; Day 60±2; Day 90±2 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in percentage of patients with MIDAS grade from baseline to end of the study.
2. Responder rate of more than 50% reduction in total MIDAS score. 		 Day 01; Day 30±2; Day 60±2; Day 90±2 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   31/07/2020 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Objective

Primary Objective

To evaluate the safety of Fixed Dose Combination (FDC) of propranolol hydrochloride 40 mg plus flunarizine 5 mg and fdc of propranolol hydrochloride 40 mg plus flunarizine 10 mg in the prophylaxis of migraine without aura.

Secondary Objective

To evaluate the efficacy of FDC of propranolol hydrochloride 40 mg plus flunarizine 5 mg and fdc of propranolol hydrochloride 40 mg plus flunarizine 10 mg in the prophylaxis of migraine without aura.

 

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