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An Open-labeled Trial of Ramipril in Patients With Migraine

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ClinicalTrials.gov Identifier: NCT01402479
Recruitment Status : Completed
First Posted : July 26, 2011
Last Update Posted : August 8, 2011
Sponsor:
Information provided by:
Seoul National University Hospital

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 Type : Interventional  (Clinical Trial)
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 : October 2004
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
Drug Information available for: Ramipril
U.S. FDA Resources

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



Primary Outcome Measures :
  1. headache frequency [ Time Frame: 12 week ]
    headache days



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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:

  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 β 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01402479


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital

Responsible Party: Manho Kim, MD, PhD, Department of Neurology, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01402479     History of Changes
Other Study ID Numbers: 0408-131-005
First Posted: July 26, 2011    Key Record Dates
Last Update Posted: August 8, 2011
Last Verified: July 2011

Keywords provided by Seoul National University Hospital:
migraine,
ramipril,
hypertension

Additional relevant MeSH terms:
Hypertension
Migraine Disorders
Vascular Diseases
Cardiovascular Diseases
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents