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CTRI Number  CTRI/2009/091/000776 [Registered on: 04/05/2010]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A phase III clinical trial for a novel herbal molecule (1% LLL-2011) developed by Lupin Li,ited which has a potential to prevent attacks of common migraine effectively. 
Scientific Title of Study   A phase III, multi-center, placebo-controlled, double blind, randomized, parallel group study to establish the efficacy of LLL-2011 administered as a 1% nasal spray in the preventive treatment of common migraine. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
LRP/CTP/017/2011/III/01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  As per the site deta+ils 
Designation   
Affiliation   
Address 

Not Applicable
N/A

India 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
 
Name  Dr. Rajesh Kumawat  
Designation   
Affiliation   
Address  Lupin Limited
Lupin research park, 46A/47A, Nande Village, Mulshi Taluka
Pune
MAHARASHTRA
411042
India 
Phone  +91-20-66749400  
Fax  +91-20-66749458  
Email  rajeshkumawat@lupinpharma.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Saji Vijayan 
Designation   
Affiliation   
Address  Lupin Limited
Lupin research park, 46A/47A, Nande Village, Mulshi Taluka
Pune
MAHARASHTRA
411042
India 
Phone  +91-20-66749461  
Fax  +91-20-66749458  
Email  sajivijayan@lupinpharma.com  
 
Source of Monetary or Material Support  
Department of Science & Technology, Technology Bhavan, New Mehrauli Road, New Delhi - 110016  
Lupin Limited (Research Park), 46A/47A, Nande village, Mulshi taluka Pune-411042, Maharashtra, India 
 
Primary Sponsor  
Name  Lupin Limited (Research Park), 46A/47A, Nande village, Mulshi taluka Pune ? 411042, Maharashtra, India  
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 13  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Mayank Patel  Neurology Clinic  22, Palm Spring Complex, Near World Business House, Parimal Garden,Ambuvadi-
Ahmadabad
GUJARAT 
079-26407372

mayank_doctornuero@yahoo.com 
Dr.Rahul Kulkarni  Deenanath Mangeshkar Hospital  Erandwane,-411004
Pune
MAHARASHTRA 
020- 2447 5927

rahulneuro@vsnl.net 
Dr. Mukesh Jain  Dr. Mukesh Jain Clinic  70/70, Madhyam Marg,Mansarovar-
Jaipur
RAJASTHAN 
0141-2783471

drmukesh13@yahoo.com 
Dr.K.S. Anand  Dr. R M L Hospital  BABA Khadak Singh Marg,-110001
New Delhi
DELHI 
011-22511275

kuljeet_anand@rediffmail.com 
Dr. Rajaram Agrawal  Fortis Escorts Hospital  JLN Marg,Malviya Nagar-302017
Jaipur
RAJASTHAN 
0141-2547000
0141-4008151
drrajaram195@rediffmail.com 
Dr. Manish Thakre  Govt. Medical College  Medical Square,-
Nagpur
MAHARASHTRA 

0712-2744489
drmanishthakre@gmail.com 
Dr. Mathew Thomas  Health & research centre  Kumarapuram,Devi Scans Building,Medical College PO-695011

 
0471-6560861
0471-2554913
amnavita@asianetindia.com 
Dr.Anand Alurkar  King Edward Memorial Hospital  Rasta Peth,-411011
Pune
MAHARASHTRA 
020- 26125600

anand_alurkar@yahoo.co.in 
Dr.V. S. Prasad  Prasad's Neuro Speciality Clinic  1st Floor, Sreeman Rama Towers,Chatanyapuri X Roads, Dilsukhnagar-500060
Hyderabad
ANDHRA PRADESH 
040-24345285
040-66499481
prasad_owaisi@yahoo.com 
Dr. S. K. Bhatter  Regency Hospital Ltd  A-2, Sarvodaya Nagar,-208005

 
91- 512-2532311
91-512-2213407
bhattersk@yahoo.co.in 
Dr. Anand G. Diwan  Shatabdi Superspeciality Hospital  Suyojit City Centre,Opp. mahamarg Bus Stand, Mumbai Naka-422005
Nashik
MAHARASHTRA 


dr_andu@rediffmail.com 
Dr. K P Poulose  Sree Uthradom Thirunal Hospital  Pattom,-695004
Thiruvananthapuram
KERALA 
0471-4077888
0471-2559488
kpp_sut@ymail.com 
Dr.Govind N.Malpani  Suyash Hospital Private Limited  Opp. M.G. Medical College,A.B. Road-
Indore
MADHYA PRADESH 
07312493911/8

malpanigovind@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Ethical Committee,Gujarat Kidney Foundation, Ahmedabad  Approved 
Ethics Committee of Sree Uthradom Thirunal Group of Hospitals  Approved 
Ethics Committee,Convenient Hospitals Ltd, Indore  Approved 
Ethics Committee,Dr. Ram Manohar Lohia Hospital,Delhi  Approved 
Independent Human Ethics Committee,Health & Research Centre,Trivandrum  Approved 
Institutional Ethics Committee,Deenanath Mangeshkar Hospital & Research Centre, Pune  Approved 
Institutional Ethics Committee,Govt. Medical College and Hospital & SSH,Nagpur  Approved 
Institutional Ethics Committee,KEMHRC,Pune  Approved 
Institutional Ethics Committee,Shatabdi Superspeciality Hospital,Nashik  Approved 
Naithika Independent Ethics Committee,Hyderabad  Approved 
Regency Hospital Ethical Committee  Approved 
Swasthya Kalyan Ethics Committee,Jaipur, Rajasthan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Common Migraine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LLL-2011  Single spray (accentuation) in each nostril twice daily approximately 12 hours apart for 3 months 
Comparator Agent  Placebo  Single spray (accentuation) in each nostril twice daily approximately 12 hours apart, for 3 months 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  1. Patients with history of migraine without aura for at least 6 months prior to screening visit for study. [As per ICHD-2.1.1] (Appendix F) 2. Patients experience 2-6 migraine attacks* per month, but not more than 15 headache days# per month. 3. Male or female patients in the age group of 18 years to 60 years (inclusive). 4. Patients willing to sign Informed Consent Form. Inclusion Criteria at Randomization Visit 1. Patients experience 2-6 migraine attacks* in placebo treatment period, but not more than 15 headache days# per month. * Each migraine attack should conform to criteria of International Classification of Headache Disorders, (2.1.1). # Headache days: Number of days in a month patient experiences headache. 
 
ExclusionCriteria 
Details  1. Patients have more than 15 headache days per month or less than 2 migraine attacks per month. 2. Patients have more than 6 attacks per year of migraine with aura. 3. Pregnant women or nursing mothers. 4. Women of child-bearing potential & all men not willing to follow a reliable & effective contraceptive measure during the course of the study & at least 3 months after the last visit. 5. Patients have commenced any form of migraine prophylactic therapy within 1 month prior to the enrollment. 6. Patients need antidepressant medicines. 7. Patients 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 a psychiatric illness. 8. Patients are diagnosed to have nasal pathologies that may interfere with the drug absorption. 9. Patients with uncontrolled diabetes, uncontrolled hypertension, epilepsy or other co-existing disease for which they require a concomitant medication with anti-migraine activity, such as: β blockers, calcium channel blockers, antidepressants or antiepileptics. 10. Patients with history of overuse or require rescue* medication for acute migraine treatment for more than 10 treatment days per month or more than 3 days per week. *Ergots or Triptans, Antiemetics, NSAIDS & Non opiate analgesics, Opiate analgesics, Barbiturate Hypnotics, Corticosteroids, local anesthetics, Botulinum toxin or anti-migraine herbal preparations. 11. History of acute myocardial infarction or stroke in 6 months preceding the signing of Informed Consent Form. 12. History of alcohol or drug dependence. 13. Unlikely to maintain a diary, comply with the medication or be regular in follow-up visits. 14. Any serious disease that would interfere with the compliance to the study protocol. 15. Patients previously participated in more than 2 migraine drug trials. 16. Patients who have received an Investigational Drug within 4 weeks prior to screening. 17. Serum SGOT and SGPT > 3 X, Alkaline Phosphatase > 1.5 X, Creatinine >1.5 X and Total bilirubin > 1.5 X the upper limits of the normal (ULN) of the reference range at the screening assessment. 18. Patients with clinically significant renal, hepatic, cardiovascular, hemopoietic, endocrinal, pulmonary, intestinal, psychiatric illness or severe mental retardation.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of LLL-2011 (1%) and placebo in reducing the frequency of migraine headaches  Baseline (visit 2) to end of treatment (visit 5) 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the effect of LLL-2011 (1%) on reduction in the intensity and duration of migraine headaches  Baseline (V2) to the end of treatment (V5) 
To study the responder rate of >50% in both active and placebo treatment groups  Baseline (visit 2) to end of treatment (visit 5) 
To determine the local tolerability profile of LLL-2011 (1%)  Visit 1 to Visit 6 
 
Target Sample Size   Total Sample Size="214"
Sample Size from India="" 
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)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/08/2009 
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)   Completed 
Recruitment Status of Trial (India)   
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This will be a multi-center, randomized, parallel group, placebo controlled, double blind study to establish the efficacy and tolerability of LLL-2011 (1%) administered as a nasal spray (accentuation) in each nostril twice daily for 3 months in the preventive treatment of common migraine. Adequate number of patients will be enrolled so as to give minimum 214 evaluable patients (107 patients in each treatment group). The total duration of the study will be approximately 5 months. The study begins with a screening evaluation. Patients fulfilling all the inclusion and exclusion criteria will be given placebo nasal spray to be administered in each nostril two times a day for 1 month. This initial 1 month, single blind placebo treatment period will establish the baseline migraine frequency attack rate. After 1 month period patients with common migraine conforming to IHS guidelines will be randomly assigned to one of the two treatment groups in a ratio of 1:1, LLL-2011 (1%) nasal spray or Placebo nasal spray, to be administered twice daily for 3 months. This period will be followed by 1 month of treatment free-follow-up period. During the entire duration of study period, patients will be allowed to use the rescue medication. However, it will require recording the use of rescue medication in the diary. 
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