The goal of this study was to evaluate the role of Enalapril as an ACE inhibitor on the improvement of headache attacks and clinical status of migraineurs and also on endothelial function as a possible mechanism of their disease. 40 migraineurs were enrolled in this clinical trial study. Migrain were diagnosed on the basis of IHS (international headache society) criteria. Patients were randomized to receive either Enalapril 5mg twice a day or placebo. FMD, blood nitrite, nitrate and CRP as markers of endothelium function and also frequency, severity and duration of headaches using a questionnaire will be measured at baseline and two months after intervention and compared between two groups. After receiving testimonial and 5cc blood, FMD will be measured in both patients and healthy groups. The bloods will transfer to -70c freezer for later nitrite & nitrate & CRP measurement.
Second step:
The migraineurs will complete a questionnaire about frequency, severity & duration of their headaches. Then we'll randomize the patients in case and control group. Case and control groups will receive 5 mg Enalapril or placebo twice a day for 2 months respectively.
After these 2 months the FMD will be measured and 5cc blood will obtain from all of the patients. They should be fast for at least 15 hours before these procedures. All of the data will be measured by the same instruments as before. Again, the migraine questionnaire will complete by patients according to their headaches in these two months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711011570N1
Registration date:2009-09-26, 1388/07/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-09-26, 1388/07/04
Registrant information
Name
Shaghayegh Haghjooy Javanmard
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2295
Email address
sh_haghjoo@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2008-08-01, 1387/05/11
Expected recruitment end date
2009-07-01, 1388/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Enalapril on endothelial dysfunction and improvement of clinical status in migraineurs
Public title
Evaluation of the effect of Enalapril on endothelial dysfunction and improvement of clinical status in migraineurs
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: having more than three migraine attacks per month during the last 3 months, having more than 3 migraine attacks during the baseline period, debut of migraine at least one year prior to study, start of migraine before age 50 years
Exclusion Criteria: Having cardiovascular (endothelial dysfunction) risk factors, undistinguishable headache interval from migraine, chronic tension-type headache or other headache occurring on more than 15 days per month, pregnancy, breast feeding, inability to use contraceptives, presence of heart conduction block on ECG or significant ECG abnormality, presence of current or previous asthma, diabetes, decreased hepatic or renal function, hypersensitivity to active substance, significant psychiatric illness, use of daily migraine prophylactics less than 4 weeks prior to study, having tried more than or equal to three prophylactic drugs against migraine during the last 10 years, previous use of Enalapril in adequate doses, previous discontinuation of Enalapril due to side effects, current use of antihypertensive medication, subjects requiring detoxification from acute medication (Ergotamines, Opioids), consistently failure to respond to any acute migraine medication, alcohol or illicit drug dependence
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Applied physiology research center, Isfahan University of Medical Sciences,
City
Esfahan
Postal code
81745
Approval date
2008-12-09, 1387/09/19
Ethics committee reference number
p12/4/1/251
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Diseases of the nervous system/Episodic and paroxysmal disorders
Primary outcomes
1
Description
Clinical status improvement
Timepoint
before intervention/1 month later/2 months later
Method of measurement
Questionnaire
2
Description
Endothelial dysfunction recovery
Timepoint
before intervention/2 months later
Method of measurement
FMD with high resolution Bmode Ultrasonographic system/NOx with Greiss method/CRP with ELISA
Secondary outcomes
1
Description
Headache frequencies
Timepoint
Before intervention,1 month, 2 month
Method of measurement
Questionnaire
2
Description
Headache durations
Timepoint
Before intervention,1 month, 2 month
Method of measurement
Questionnaire
3
Description
Headache severity
Timepoint
Before intervention,1 month, 2 month
Method of measurement
Questionnaire
4
Description
FMD Index
Timepoint
Before intervention,2 months later
Method of measurement
High resolution Bmode Ultrasonography
5
Description
Level of CRP
Timepoint
Before intervention,2 months later
Method of measurement
ELISA
6
Description
NOx
Timepoint
before intervention,2 months later
Method of measurement
Greiss method
Intervention groups
1
Description
Enalapril, 5 mg tablet, twice a day for 2 months
Category
Treatment - Drugs
2
Description
Oral placebo tablet, twice a day for 2 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology clinic of al-zahra hospital, Isfahan University of Medical Sciences
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences, Applied Physiology Research Center
Full name of responsible person
Shaghayegh Haghjooiejavanmard
Street address
Isfahan University of Medical Sciences, Hezarjarib st.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences, Applied Physiology Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooi-e-javanmard
Position
Assistant professor/PhD.MD
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences,Applied physiology research center
City
Esfahan
Postal code
Phone
Fax
Email
shaghayeghhaghjoo@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooi-e-javanmard
Position
Assistant professor/PhD.MD
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences,Applied physiology research center
City
Isfahan
Postal code
81745
Phone
+98 31 1792 2295
Fax
Email
shaghayeghhaghjoo@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooi-e-javanmard
Position
Assistant professor/PhD.MD
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences,Applied physiology research center
City
Isfahan
Postal code
81745
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)