An Open-labeled Trial of Ramipril in Patients With Migraine

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01402479
First received: July 24, 2011
Last updated: August 5, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Migraine With Hypertension
Drug: Ramipril
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-labeled Trial of Ramipril in Patients With Migraine

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

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


Enrollment: 50
Study Start Date: October 2004
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ramipril
open label single arm trial
Drug: Ramipril
ramipril 2.5mg twice a day

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402479

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

No publications provided

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
Study First Received: July 24, 2011
Last Updated: August 5, 2011
Health Authority: South Korea: Korea Food and Drug Administration

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
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014