NCT00505570

Brief Summary

The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2006

Longer than P75 for phase_2

Geographic Reach
4 countries

17 active sites

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2007

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

6.8 years

First QC Date

July 20, 2007

Last Update Submit

February 1, 2019

Conditions

MigraineMigraine With AuraPatent Foramen OvalePFO

Keywords

MigraineMigraine with auraPatent foramen ovalePFO

Outcome Measures

Primary Outcomes (1)

  • Migraine headache frequency

    12 months

Secondary Outcomes (1)

  • Responder rate; Acute migraine medication use; Quality of life evaluations; Effects of Anti-thrombotic medications; Adverse events; PFO Closure

    12 months

Study Arms (2)

Medical Management

NO INTERVENTION

PFO Closure

EXPERIMENTAL
Device: AMPLATZER® PFO Occluder Device

Interventions

AMPLATZER® PFO Occluder DeviceDEVICE

PFO device closure

PFO Closure

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who are age 18 to 65
  • Subjects who have migraine headaches with aura diagnosed by a doctor
  • Subjects who have not responded to or cannot take common migraine preventive medications

You may not qualify if:

  • Subjects with a clinical history of stroke
  • Subjects who cannot take aspirin and clopidogrel (Plavix)
  • Subjects who are pregnant or desire to become pregnant within the next year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

University of Calgary- Foothills Hospital

Calgary, Alberta, T2N 2T9, Canada

Location

Alberta Health Services and the University of Alberta

Edmonton, Alberta, Canada

Location

University of British Columbia

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

University of Ottawa

Ottawa, Ontario, K1H 1A2, Canada

Location

Davisville Medical Center

Toronto, Ontario, M4S 1Y2, Canada

Location

Institut de Cardiologie de Montreal

Montreal, Quebec, H1T 1C8, Canada

Location

Centre Hospitalier Universitaire de Québec

Québec, Quebec, G1V 4G5, Canada

Location

Unfallkrankenhaus Berlin

Berlin, 12683, Germany

Location

Martin-Luther-University Halle-Wittenberg

Halle, 06120, Germany

Location

Universitätsklinikum Hamburg

Hamburg, 20246, Germany

Location

Neurologisch-verhaltensmedizinische Schmerzklinik Kiel

Kiel, 24149, Germany

Location

Universitätsklinikum Münster

Münster, 48129, Germany

Location

Swiss Cardiovascular Center Bern

Bern, 3010, Switzerland

Location

Kopfwehzentrum Hirslanden Zürich

Zurich, 8088, Switzerland

Location

Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

Location

St. Mary's Hospital Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

South Manchester University Hospital

Manchester, M23 9LT, United Kingdom

Location

Related Publications (1)

  • Mattle HP, Evers S, Hildick-Smith D, Becker WJ, Baumgartner H, Chataway J, Gawel M, Gobel H, Heinze A, Horlick E, Malik I, Ray S, Zermansky A, Findling O, Windecker S, Meier B. Percutaneous closure of patent foramen ovale in migraine with aura, a randomized controlled trial. Eur Heart J. 2016 Jul 7;37(26):2029-36. doi: 10.1093/eurheartj/ehw027. Epub 2016 Feb 22.

    PMID: 26908949DERIVED

MeSH Terms

Conditions

Migraine DisordersMigraine with AuraForamen Ovale, Patent

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeart Septal Defects, AtrialHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Prima Trial Steering Committee

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2007

First Posted

July 23, 2007

Study Start

May 1, 2006

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

GB(3)DE(5)CH(2)CA(7)