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Evaluation of the effect of Enalapril on endothelial dysfunction and improvement of clinical status in migraineurs

Evaluation of the effect of Enalapril on endothelial dysfunction and improvement of clinical status in migraineurs

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT138711011570N1
Enrollment
40
Registered
2009-09-26
Start date
2008-08-01
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine. Diseases of the nervous system/Episodic and paroxysmal disorders

Interventions

Intervention 1: Enalapril, 5 mg tablet, twice a day for 2 months. Intervention 2: Oral placebo tablet, twice a day for 2 months.
Treatment - Drugs
Placebo
Enalapril, 5 mg tablet, twice a day for 2 months
Oral placebo tablet, twice a day for 2 months

Sponsors

Isfahan University of Medical Sciences, Applied Physiology Research Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShaghayegh Haghjooi-e-javanmard

Isfahan University of Medical Sciences

shaghayeghhaghjoo@yahoo.com

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026