PREMIUM Migraine Trial
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|ClinicalTrials.gov Identifier: NCT00355056|
Recruitment Status : Completed
First Posted : July 21, 2006
Results First Posted : July 30, 2020
Last Update Posted : July 30, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Migraine Headaches Patent Foramen Ovale||Other: Sham Procedure Device: AMPLATZER PFO Occluder||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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 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).
- 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.
- 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.
- 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
- 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.
- Incidence of a 75% Reduction in Migraine Headache Attacks [ Time Frame: 12 months ]
- 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.
- 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.
- Incidence of All Adverse Events at 12-months [ Time Frame: 12 months ]
- Incidence of Device-related Adverse Events [ Time Frame: 12 months ]
- Incidence of a 95% Reduction in Migraine Headache Attacks [ Time Frame: 12-months ]
- 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.
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.
|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
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
|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|
|Responsible Party:||Abbott Medical Devices|
|Other Study ID Numbers:||
|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|
patent foramen ovale
Foramen Ovale, Patent
Headache Disorders, Primary
Central Nervous System Diseases
Nervous System Diseases
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital