An Open-labeled Trial of Ramipril in Patients With Migraine

Migraine With Hypertension Clinical Trial

Official title:

An Open-labeled Trial of Ramipril in Patients With Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01402479
• Other study ID #: 0408-131-005
• Status: Completed
• Phase: Phase 2
• First received: July 24, 2011
• Last updated: August 5, 2011
• Start date: October 2004
• Est. completion date: July 2005

Study information

• Verified date: July 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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:

1. Medication overuse headache are excluded in this study.

2. Treatment with other ACEI or medication that may affect ARS

3. Treatment with migraine prophylactic medications or anti-hypertensive agents including ß adrenergic receptor or calcium channel blockers

4. 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine With Hypertension

Intervention

Drug:
• Ramipril
ramipril 2.5mg twice a day

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	headache frequency	headache days	12 week