Back to resultsAn Open-labeled Trial of Ramipril in Patients With Migraine
Primary Purpose
Migraine With Hypertension
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ramipril
Sponsored by
About this trial
This is an interventional treatment trial for Migraine With Hypertension focused on measuring migraine,, ramipril,, hypertension
Eligibility Criteria
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.
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
ramipril
Arm Description
open label single arm trial
Outcomes
Primary Outcome Measures
headache frequency
headache days
Secondary Outcome Measures
Full Information
NCT ID
NCT01402479
First Posted
July 24, 2011
Last Updated
August 5, 2011
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01402479
Brief Title
An Open-labeled Trial of Ramipril in Patients With Migraine
Official Title
An Open-labeled Trial of Ramipril in Patients With Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With Hypertension
Keywords
migraine,, ramipril,, hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ramipril
Arm Type
Active Comparator
Arm Description
open label single arm trial
Intervention Type
Drug
Intervention Name(s)
Ramipril
Intervention Description
ramipril 2.5mg twice a day
Primary Outcome Measure Information:
Title
headache frequency
Description
headache days
Time Frame
12 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
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.
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
An Open-labeled Trial of Ramipril in Patients With Migraine
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