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Completed

NCT Number: NCT00355056

PREMIUM Migraine Trial

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.

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Key information

Conditions

Migraine Headaches Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foramen Ovale, Patent Headache Disorders Headache Disorders, Primary Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Migraine Disorders Nervous System Diseases Patent Foramen Ovale

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Hospital & Medical Center, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sham Procedure

Other

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.

AMPLATZER PFO Occluder

Device

Patients in this arm will receive the AMPLATZER PFO Occluder device

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management.

Important dates

Study start
2006
Primary completion
2015
Study completion
2015
First posted
Jul 21, 2006
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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