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Trial record 1 of 1 for:    NCT00505570
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PRIMA PFO Migraine Trial (PRIMA)

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ClinicalTrials.gov Identifier: NCT00505570
Recruitment Status : Terminated
First Posted : July 23, 2007
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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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.

Condition or disease Intervention/treatment Phase
Migraine Migraine With Aura Patent Foramen Ovale PFO Device: AMPLATZER® PFO Occluder Device Phase 2

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Percutaneous Closure of Patent Foramen Ovale In Migraine With Aura - A Randomized Prospective Study (Prima Trial)
Study Start Date : May 2006
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Medical Management
Experimental: PFO Closure Device: AMPLATZER® PFO Occluder Device
PFO device closure


Outcome Measures
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Primary Outcome Measures :
  1. Migraine headache frequency [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Responder rate; Acute migraine medication use; Quality of life evaluations; Effects of Anti-thrombotic medications; Adverse events; PFO Closure [ Time Frame: 12 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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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): NCT00505570


Locations
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Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Chair: Prima Trial Steering Committee
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT00505570    
Other Study ID Numbers: AGA010E
First Posted: July 23, 2007    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Keywords provided by Abbott Medical Devices:
Migraine
Migraine with aura
Patent foramen ovale
PFO
Additional relevant MeSH terms:
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Migraine Disorders
Migraine with Aura
Foramen Ovale, Patent
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities