Clinical Trial Details (PDF Generation Date :- Tue, 24 Aug 2021 11:04:52 GMT)

PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Thu, 30 Sep 2021 13:17:16 GMT)

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 A phase III, multi-center, placebo-controlled, double blind, randomized, parallel group study to Study establish the efficacy of LLL-2011 administered as a 1% nasal spray in the preventive treatment of common migraine. Secondary IDs if Any Secondary ID Identifier LRP/CTP/017/2011/III/01 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name As per the site deta+ils Trial Coordinator (multi-center study) Designation Affiliation Address Not Applicable N/A

India Phone Fax Email Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr. Rajesh Kumawat Query) 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 [email protected] Details Contact Details Contact Person (Public Query) 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

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Fax +91-20-66749458 Email [email protected] Source of Monetary or Source of Monetary or Material Support 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 Primary Sponsor Details Name Lupin Limited (Research Park), 46A/47A, Nande village, Mulshi taluka Pune ? 411042, Maharashtra, India Address Type of Sponsor Details of Secondary Name Address Sponsor Nil Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr. Mayank Patel Neurology Clinic 22, Palm Spring 079-26407372 Complex, Near World Business House, mayank_doctornuero@ Parimal yahoo.com Garden,Ambuvadi- Ahmadabad GUJARAT Dr.Rahul Kulkarni Deenanath Mangeshkar Erandwane,-411004 020- 2447 5927 Hospital Pune MAHARASHTRA [email protected] Dr. Mukesh Jain Dr. Mukesh Jain Clinic 70/70, Madhyam 0141-2783471 Marg,Mansarovar- Jaipur [email protected] RAJASTHAN m Dr.K.S. Anand Dr. R M L Hospital BABA Khadak Singh 011-22511275 Marg,-110001 New Delhi kuljeet_anand@rediffm DELHI ail.com Dr. Rajaram Agrawal Fortis Escorts Hospital JLN Marg,Malviya 0141-2547000 Nagar-302017 0141-4008151 Jaipur drrajaram195@rediffma RAJASTHAN il.com Dr. Manish Thakre Govt. Medical College Medical Square,- 0712-2744489 Nagpur drmanishthakre@gmail. MAHARASHTRA com Dr. Mathew Thomas Health & research Kumarapuram,Devi 0471-6560861 centre Scans Building,Medical 0471-2554913 College PO-695011 amnavita@asianetindia. Not Applicable com N/A Dr.Anand Alurkar King Edward Memorial Rasta Peth,-411011 020- 26125600 Hospital Pune MAHARASHTRA anand_alurkar@yahoo. co.in Dr.V. S. Prasad Prasad's Neuro 1st Floor, Sreeman 040-24345285

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Speciality Clinic Rama 040-66499481 Towers,Chatanyapuri X prasad_owaisi@yahoo. Roads, com Dilsukhnagar-500060 Hyderabad ANDHRA PRADESH Dr. S. K. Bhatter Regency Hospital Ltd A-2, Sarvodaya 91- 512-2532311 Nagar,-208005 91-512-2213407 Not Applicable [email protected] N/A Dr. Anand G. Diwan Shatabdi Suyojit City Superspeciality Hospital Centre,Opp. mahamarg [email protected] Bus Stand, Mumbai m Naka-422005 Nashik MAHARASHTRA Dr. K P Poulose Sree Uthradom Thirunal Pattom,-695004 0471-4077888 Hospital Thiruvananthapuram 0471-2559488 KERALA [email protected] Dr.Govind N.Malpani Suyash Hospital Private Opp. M.G. Medical 07312493911/8 Limited College,A.B. Road- Indore malpanigovind@yahoo. MADHYA PRADESH co.in Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Ethical Approved No Date Specified Not Available Committee,Gujarat Kidney Foundation, Ahmedabad Ethics Committee of Approved No Date Specified Not Available Sree Uthradom Thirunal Group of Hospitals Ethics Approved No Date Specified Not Available Committee,Convenient Hospitals Ltd, Indore Ethics Committee,Dr. Approved No Date Specified Not Available Ram Manohar Lohia Hospital,Delhi Independent Human Approved No Date Specified Not Available Ethics Committee,Health & Research Centre,Trivandrum Institutional Ethics Approved No Date Specified Not Available Committee,Deenanath Mangeshkar Hospital & Research Centre, Pune Institutional Ethics Approved No Date Specified Not Available Committee,Govt. Medical College and Hospital & SSH,Nagpur Institutional Ethics Com Approved No Date Specified Not Available mittee,KEMHRC,Pune Institutional Ethics Approved No Date Specified Not Available Committee,Shatabdi Superspeciality Hospital,Nashik

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Naithika Independent Approved No Date Specified Not Available Ethics Committee,Hyderabad Regency Hospital Approved No Date Specified Not Available Ethical Committee Swasthya Kalyan Ethics Approved No Date Specified Not Available Committee,Jaipur, Rajasthan Regulatory Clearance Status Date Status from DCGI Approved/Obtained No Date Specified Health Condition / Health Type Condition Problems Studied Common Migraine Intervention / Type Name Details Comparator Agent 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 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. Exclusion Criteria Exclusion Criteria 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

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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 Computer generated randomization Random Sequence Method of Centralized Concealment Blinding/Masking Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints To assess the effect of LLL-2011 (1%) and Baseline (visit 2) to end of treatment (visit 5) placebo in reducing the frequency of migraine headaches Secondary Outcome Outcome Timepoints To determine the effect of LLL-2011 (1%) on Baseline (V2) to the end of treatment (V5) reduction in the intensity and duration of migraine headaches To study the responder rate of >50% in both Baseline (visit 2) to end of treatment (visit 5) active and placebo treatment groups To determine the local tolerability profile of Visit 1 to Visit 6 LLL-2011 (1%) 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 No Date Specified Enrollment (India) Date of First 01/08/2009 Enrollment (Global) Estimated Duration of Years=1 Trial Months=0 Days=0 Recruitment Status of Completed Trial (Global) Recruitment Status of Trial (India) Publication Details 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

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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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