NCT01402479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
Last Updated

August 8, 2011

Status Verified

July 1, 2011

Enrollment Period

9 months

First QC Date

July 24, 2011

Last Update Submit

August 5, 2011

Conditions

Migraine With Hypertension

Keywords

migraine,ramipril,hypertension

Outcome Measures

Primary Outcomes (1)

  • headache frequency

    headache days

    12 week

Study Arms (1)

ramipril

ACTIVE COMPARATOR

open label single arm trial

Drug: Ramipril

Interventions

RamiprilDRUG

ramipril 2.5mg twice a day

ramipril

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Migraine DisordersHypertension

Interventions

Ramipril

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2011

First Posted

July 26, 2011

Study Start

October 1, 2004

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

August 8, 2011

Record last verified: 2011-07

Locations

KR(1)