CTRI Number |
CTRI/2009/091/000776 [Registered on: 04/05/2010] |
Last Modified On: |
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Post Graduate Thesis |
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Type of Trial |
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Type of Study
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Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
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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
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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 |
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Secondary IDs if Any
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Secondary ID |
Identifier |
LRP/CTP/017/2011/III/01 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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Name |
As per the site deta+ils |
Designation |
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Affiliation |
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Address |
Not Applicable N/A
India |
Phone |
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Fax |
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Email |
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Details of Contact Person Scientific Query
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Name |
Dr. Rajesh Kumawat |
Designation |
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Affiliation |
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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 |
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Details of Contact Person Public Query
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Name |
Dr. Saji Vijayan |
Designation |
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Affiliation |
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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 |
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Source of Monetary or Material Support
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Department of Science & Technology,
Technology Bhavan, New Mehrauli Road,
New Delhi - 110016
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Lupin Limited (Research Park), 46A/47A, Nande village, Mulshi taluka Pune-411042, Maharashtra, India |
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Primary Sponsor
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Name |
Lupin Limited (Research Park), 46A/47A, Nande village, Mulshi taluka Pune ? 411042, Maharashtra, India |
Address |
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Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
Sites of Study
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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
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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
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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 |
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Details of Ethics Committee
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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 |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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Health Type |
Condition |
Patients |
Common Migraine, |
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Intervention / Comparator Agent
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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 |
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Inclusion Criteria
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Age From |
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Age To |
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Gender |
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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. |
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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.
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Method of Generating Random Sequence
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Computer generated randomization |
Method of Concealment
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Centralized |
Blinding/Masking
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Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
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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) |
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Secondary Outcome
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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 |
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Target Sample Size
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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
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Phase 3 |
Date of First Enrollment (India)
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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
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Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
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Completed |
Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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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. |