An Open-labeled Trial of Ramipril in Patients With Migraine

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01402479

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Physiology of migraine involving renin-angiotensin systems (RAS) has been implicated. Ramipril is a broadly-used angiotensin-converting enzyme inhibitor. The investigators attempt to test the efficacy of ramipril on the prophylaxis of migraine attacks.

Condition or Disease	Intervention/Treatment	Phase
Migraine With Hypertension	Drug: Ramipril	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-labeled Trial of Ramipril in Patients With Migraine

Study Start Date :

Oct 1, 2004

Actual Primary Completion Date :

Jul 1, 2005

Actual Study Completion Date :

Jul 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ramipril open label single arm trial	Drug: Ramipril ramipril 2.5mg twice a day

Arm

Intervention/Treatment

Active Comparator: ramipril

open label single arm trial

Drug: Ramipril

ramipril 2.5mg twice a day

Outcome Measures

Primary Outcome Measures

headache frequency [12 week]
headache days

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Patients with chronic migraine are included in this study. Migraineurs should be aged 20 to 70 years old with the ability to read and understand the self-report scales, including the headache diary, used in this study.

Exclusion Criteria:

Medication overuse headache are excluded in this study.
Treatment with other ACEI or medication that may affect ARS
Treatment with migraine prophylactic medications or anti-hypertensive agents including β adrenergic receptor or calcium channel blockers
Past history of hepatic or renal dysfunction; an abnormal electrocardiography; a psychiatric disorder; a history of substance abuse; pregnancy or lactation; use of anti-psychotics, antidepressants, or anti-anxiety drugs.