Evaluation of the effect of Enalapril on endothelial dysfunction and improvement of clinical status in migraineurs
- Conditions
- Migraine.Diseases of the nervous system/Episodic and paroxysmal disorders
- Registration Number
- IRCT138711011570N1
- Lead Sponsor
- Isfahan University of Medical Sciences, Applied Physiology Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical status improvement. Timepoint: before intervention/1 month later/2 months later. Method of measurement: Questionnaire.;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 Outcome Measures
Name Time Method Headache frequencies. Timepoint: Before intervention,1 month, 2 month. Method of measurement: Questionnaire.;Headache durations. Timepoint: Before intervention,1 month, 2 month. Method of measurement: Questionnaire.;Headache severity. Timepoint: Before intervention,1 month, 2 month. Method of measurement: Questionnaire.;FMD Index. Timepoint: Before intervention,2 months later. Method of measurement: High resolution Bmode Ultrasonography.;Level of CRP. Timepoint: Before intervention,2 months later. Method of measurement: ELISA.;NOx. Timepoint: before intervention,2 months later. Method of measurement: Greiss method.