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PRIMA PFO Migraine Trial (PRIMA)

Primary Purpose

Migraine, Migraine With Aura, Patent Foramen Ovale

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AMPLATZER® PFO Occluder Device
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine focused on measuring Migraine, Migraine with aura, Patent foramen ovale, PFO

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Calgary- Foothills Hospital
  • Alberta Health Services and the University of Alberta
  • University of British Columbia
  • University of Ottawa
  • Davisville Medical Center
  • Institut de Cardiologie de Montreal
  • Centre Hospitalier Universitaire de Québec
  • Unfallkrankenhaus Berlin
  • Martin-Luther-University Halle-Wittenberg
  • Universitätsklinikum Hamburg
  • Neurologisch-verhaltensmedizinische Schmerzklinik Kiel
  • Universitätsklinikum Münster
  • Swiss Cardiovascular Center Bern
  • Kopfwehzentrum Hirslanden Zürich
  • Royal Sussex County Hospital
  • St. Mary's Hospital Imperial College Healthcare NHS Trust
  • South Manchester University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Medical Management

PFO Closure

Arm Description

Outcomes

Primary Outcome Measures

Migraine headache frequency

Secondary Outcome Measures

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

Full Information

First Posted
July 20, 2007
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00505570
Brief Title
PRIMA PFO Migraine Trial
Acronym
PRIMA
Official Title
Percutaneous Closure of Patent Foramen Ovale In Migraine With Aura - A Randomized Prospective Study (Prima Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Study Start Date
May 2006 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Migraine With Aura, Patent Foramen Ovale, PFO
Keywords
Migraine, Migraine with aura, Patent foramen ovale, PFO

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medical Management
Arm Type
No Intervention
Arm Title
PFO Closure
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
AMPLATZER® PFO Occluder Device
Intervention Description
PFO device closure
Primary Outcome Measure Information:
Title
Migraine headache frequency
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Responder rate; Acute migraine medication use; Quality of life evaluations; Effects of Anti-thrombotic medications; Adverse events; PFO Closure
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prima Trial Steering Committee
Official's Role
Study Chair
Facility Information:
Facility Name
University of Calgary- Foothills Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Alberta Health Services and the University of Alberta
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
University of Ottawa
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1A2
Country
Canada
Facility Name
Davisville Medical Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4S 1Y2
Country
Canada
Facility Name
Institut de Cardiologie de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Québec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Unfallkrankenhaus Berlin
City
Berlin
ZIP/Postal Code
12683
Country
Germany
Facility Name
Martin-Luther-University Halle-Wittenberg
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitätsklinikum Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Neurologisch-verhaltensmedizinische Schmerzklinik Kiel
City
Kiel
ZIP/Postal Code
24149
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48129
Country
Germany
Facility Name
Swiss Cardiovascular Center Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Kopfwehzentrum Hirslanden Zürich
City
Zürich
ZIP/Postal Code
8088
Country
Switzerland
Facility Name
Royal Sussex County Hospital
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
St. Mary's Hospital Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
South Manchester University Hospital
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26908949
Citation
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.
Results Reference
derived

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PRIMA PFO Migraine Trial

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