| CTRI Number |
CTRI/2010/091/000539 [Registered on: 31/08/2010] |
| 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, Multiple Arm Trial |
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Public Title of Study
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A clinical trial to compare the effects of riboflavin and propranolol in preventive therapy of migraine |
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Scientific Title of Study
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Randomized, double-blind, placebo-controlled
study to compare the efficacy of riboflavin versus propranolol in prophylaxis of migraine
Acronym: RiMiPro |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Y K Gupta |
| Designation |
|
| Affiliation |
|
| Address |
Room No. 4012, Deptt. of Pharmacology
4th floor, Teaching Block, AIIMS
New Delhi
DELHI
110029
India |
| Phone |
01126593282 |
| Fax |
01126588641 |
| Email |
yk.ykgupta@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr. Arun Kumar Dahiya |
| Designation |
|
| Affiliation |
|
| Address |
Room No. 4012, Deptt. of Pharmacology
4th floor, Teaching Block, AIIMS
New Delhi
DELHI
110029
India |
| Phone |
01126593282 |
| Fax |
01126588641 |
| Email |
drarundahiya@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
Dr. Y K Gupta |
| Designation |
|
| Affiliation |
|
| Address |
Room No. 4012, Deptt. of Pharmacology
4th floor, Teaching Block, AIIMS
New Delhi
DELHI
110029
India |
| Phone |
01126593282 |
| Fax |
01126588641 |
| Email |
yk.ykgupta@gmail.com |
|
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Source of Monetary or Material Support
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| All India Institute of Medical Sciences, New Delhi |
| NIL |
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Primary Sponsor
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| Name |
Dr. Y K Gupta |
| 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 |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Kh Reeta |
All India Institute of Medical Sciences, New Delhi |
Room No. 4012, Deptt of Pharmacology,4th floor, Teaching Block, AIIMS-110029
New Delhi
DELHI |
011-26593282
reetakh@gmail.com |
|
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS |
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 |
Migraine, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Placebo |
B.D. For 3 Months |
| Comparator Agent |
Propranolol |
40 mg b.d. for 3 months |
| Intervention |
Riboflavin |
20 mg B.D. 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.Patient of either sex between age group18-65 years who have not received any drug for migraine prophylaxis before.
2.Medical history consistent with migraine with or without aura according to the International Headache Society (IHS) for at least 1 year prior to the study.
3.More than four migraine episodes per month but no greater than 15 headache days (migraine and non-migraine) in one month during the baseline phase. There should be a gap of at least 48 hours between two episodes. Frequency of non-migraine headaches should be no more than 6 episodes per month.
4.No significant abnormalities on clinical examination at baseline.
5.Female patients must be either postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception during the complete study period.
6.Willing to provide informed consent.
7.Patients able to maintain a headache diary. |
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| ExclusionCriteria |
| Details |
1.Patients with headaches other than migraine who cannot differentiate migraine from other headaches.
2.Onset of migraine after age of 50 years
3.Patients who have taken antipsychotics or antidepressants during the previous 3 months.
4.Patients who abuse alcohol or other drugs.
5.Patients who use drugs excessively for headache (more than 10 days per month).
6.Pregnant or lactating women
7.Patients with heart or kidney diseases, asthma or diabetes or otherwise unhealthy. |
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Method of Generating Random Sequence
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Permuted block randomization, variable |
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Method of Concealment
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Pre-numbered or coded identical Containers |
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Blinding/Masking
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Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Percentage of patients who achieved 50% or greater decrease in the number of migraine attacks during the 3rd month, compared to the run-in month. |
3 months |
|
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Secondary Outcome
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| Outcome |
TimePoints |
| ?Percentage of patients who achieved 50% or greater decrease in the number of migraine days during the 3rd month, compared to the run-in month.
?Difference between the two groups in the third month regarding the use of rescue medications and regarding the adverse effects. |
3 months |
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Target Sample Size
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Total Sample Size="120"
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" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/03/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="1"
Months="3"
Days="0" |
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Recruitment Status of Trial (Global)
|
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 study was a randomized, double-blind, placebo-controlled parallel group, single-center trial to compare the efficacy and safety of Riboflavin 20 mg b.d. with Propranolol 40 mg b.d. for 3 months in prophylaxis of migraine. The trial had three arms: 1) Riboflavin 20 mg b.d. for 3 months; 2) Propranolol 40 mg b.d. for 3 months; and 3) Placebo b.d. for 3 months. The primary outcome measure was the percentage of patients who achieved 50% or greater decrease in the number of migraine attacks during the 3rd month, compared to the run-in month. The trial has completed, however, the results have not been submitted/published anywhere. |