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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 20, 2007
First Posted Date  ICMJE July 23, 2007
Last Update Posted Date February 4, 2019
Study Start Date  ICMJE May 2006
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2010)
Migraine headache frequency [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 20, 2007)
Migraine headache frequency
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2010)
Responder rate; Acute migraine medication use; Quality of life evaluations; Effects of Anti-thrombotic medications; Adverse events; PFO Closure [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2007)
Responder rate; Acute migraine medication use; Quality of life evaluations; Adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PRIMA PFO Migraine Trial
Official Title  ICMJE Percutaneous Closure of Patent Foramen Ovale In Migraine With Aura - A Randomized Prospective Study (Prima Trial)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Migraine
  • Migraine With Aura
  • Patent Foramen Ovale
  • PFO
Intervention  ICMJE Device: AMPLATZER® PFO Occluder Device
PFO device closure
Study Arms  ICMJE
  • No Intervention: Medical Management
  • Experimental: PFO Closure
    Intervention: Device: AMPLATZER® PFO Occluder Device
Publications * Mattle HP, Evers S, Hildick-Smith D, Becker WJ, Baumgartner H, Chataway J, Gawel M, Göbel 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 22, 2013)
107
Original Estimated Enrollment  ICMJE
 (submitted: July 20, 2007)
2000
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00505570
Other Study ID Numbers  ICMJE AGA010E
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Prima Trial Steering Committee
PRS Account Abbott Medical Devices
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP