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PREMIUM Migraine Trial

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: NCT00355056
Recruitment Status : Completed
First Posted : July 21, 2006
Results First Posted : July 30, 2020
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The Purpose of this study is to evaluate the impact of percutaneous closure of a patent foramen ovale (PFO) (a hole in the heart), using the AMPLATZER PFO Occluder, on the incidence of migraine headaches.

Condition or disease Intervention/treatment Phase
Migraine Headaches Patent Foramen Ovale Other: Sham Procedure Device: AMPLATZER PFO Occluder Not Applicable

Detailed Description:
The objective of this study is to evaluate whether percutaneous PFO closure is effective in reducing the incidence of disabling migraine headaches in patients who are refactory to medical treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management.
Study Start Date : January 2006
Actual Primary Completion Date : February 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Sham Comparator: Medical Management
Will not receive the closure device, and will be treated with the current standard of care medical treatment. Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and simulate PFO closure procedure (sham procedure).
Other: Sham Procedure
Will not receive the closure device, and will be treated with the current standard of care medical treatment. Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and simulate PFO closure procedure (sham procedure). Participants completing 1 year follow-up are eligible for PFO closure with the AMPLATZER PFO Occluder.

Experimental: PFO Closure
Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and undergo PFO device closure procedure with the AMPLATZER PFO Occluder.
Device: AMPLATZER PFO Occluder
Patients in this arm will receive the AMPLATZER PFO Occluder device




Primary Outcome Measures :
  1. Primary Efficacy Endpoint - Percentage of Subjects With a 50% Reduction From Baseline in the Monthly Number of Migraine Attacks at 12 Months. [ Time Frame: Baseline and months 10-12 ]
    A 50% reduction from the monthly number of migraine attacks during the 60-day baseline phase to the monthly number of migraine attacks during month ten through the twelfth month in the treatment phase (device group versus sham group).

  2. Primary Safety Endpoint - Device Related Serious Adverse Event (SAE) [ Time Frame: Baseline through 12 months ]

    Number of subjects who experience a device-related major adverse event (DRMAE) through 12-months of follow-up.

    This endpoint was analyzed using an as-treated cohort that consists of all enrolled subjects who received the device (randomized and Optional PFO Closure group) and who had follow-up sufficient to adequately assess the DRMAE rate.



Secondary Outcome Measures :
  1. Change in Mean Migraine Days/Month [ Time Frame: Baseline and months 10-12 ]
    Change in the number of migraine days is calculated by the difference in the mean number of migraine days between the baseline assessment period and the treatment phase (months 10-12 post-procedure) for the respective randomization groups.

  2. Percentage of Subjects With Successful PFO Closure at 12-months [ Time Frame: Baseline and month 12 ]
    Successful Closure by Core Lab Adjudicated Transcranial Doppler (TCD) Grade <= 2

  3. Change in Migraine Disability Assessment (MIDAS) Score From Baseline to 12-months [ Time Frame: 12 months ]
    The MIDAS questionnaire measure the impact of headaches on daily living. A total score of 0-5 equals little to no disability, 6-10 equals mild disability, 11-20 equals moderate disability, and a score 21 or greater equals severe disability. The maximum possible score is 276.

  4. Incidence of a 75% Reduction in Migraine Headache Attacks [ Time Frame: 12 months ]
  5. Procedural Success [ Time Frame: 12 months ]
    Procedural success is calculated by the percent of device group subjects who were implanted with the study device and experienced no serious device or procedure-related adverse events.

  6. Long-Term Success [ Time Frame: 12 months ]
    Percent of PFO closure group subjects who were implanted with the study device, experienced no serious device or procedure-related adverse events and have a core-lab adjudicated TCD Grade at Valsalva ≤ 2 at 1-year.

  7. Incidence of All Adverse Events at 12-months [ Time Frame: 12 months ]
  8. Incidence of Device-related Adverse Events [ Time Frame: 12 months ]
  9. Incidence of a 95% Reduction in Migraine Headache Attacks [ Time Frame: 12-months ]

Other Outcome Measures:
  1. Change in Beck Depression Inventory (BDI) Scale [ Time Frame: 12 months ]
    The difference in BDI between baseline and 12-months for the respective randomization groups. The highest possible score of the BDI is 63, which represents extreme depression. The lowest possible score is 0, which represents no depression.



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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 diagnosed as having migraine headaches both with and without aura
  • Have a Patent Foramen Ovale (PFO)
  • A migraine history and show a refractoriness to medical treatment
  • Willing to participate in follow-up visits

Exclusion Criteria:

  • Subjects whose primary headaches are other than migraine headaches
  • Who overuse migraine treatments
  • With a clinical history of stroke or Transient Ischemic Attack (TIA)
  • With contraindication to aspirin therapy and Clopidogrel
  • Pregnant or desire to become pregnant within the next year

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): NCT00355056


Locations
Show Show 30 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Sherman Sorensen, M.D. Intermountain Medical Center
Principal Investigator: Stephen Silberstein, M.D. Thomas Jefferson University
Principal Investigator: Jonathan Tobis, M.D. University of California, Los Angeles
Principal Investigator: Andrew Charles, MD University of California, Los Angeles
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT00355056    
Other Study ID Numbers: AGA-010
First Posted: July 21, 2006    Key Record Dates
Results First Posted: July 30, 2020
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Abbott Medical Devices:
Migraine
PFO
Migraine Headache
patent foramen ovale
Additional relevant MeSH terms:
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Migraine Disorders
Foramen Ovale, Patent
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities