PREMIUM Migraine Trial
Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management.
1 other identifier
interventional
230
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2006
Longer than P75 for not_applicable
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 19, 2006
CompletedFirst Posted
Study publicly available on registry
July 21, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
July 30, 2020
CompletedJuly 30, 2020
July 1, 2020
9.1 years
July 19, 2006
May 2, 2016
July 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary Efficacy Endpoint - Percentage of Subjects With a 50% Reduction From Baseline in the Monthly Number of Migraine Attacks at 12 Months.
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).
Baseline and months 10-12
Primary Safety Endpoint - Device Related Serious Adverse Event (SAE)
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.
Baseline through 12 months
Secondary Outcomes (9)
Change in Mean Migraine Days/Month
Baseline and months 10-12
Percentage of Subjects With Successful PFO Closure at 12-months
Baseline and month 12
Change in Migraine Disability Assessment (MIDAS) Score From Baseline to 12-months
12 months
Incidence of a 75% Reduction in Migraine Headache Attacks
12 months
Procedural Success
12 months
- +4 more secondary outcomes
Other Outcomes (1)
Change in Beck Depression Inventory (BDI) Scale
12 months
Study Arms (2)
Medical Management
SHAM COMPARATORWill 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).
PFO Closure
EXPERIMENTALWill undergo Intracardiac Echo (ICE) in cardiac catheterization lab and undergo PFO device closure procedure with the AMPLATZER PFO Occluder.
Interventions
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.
Patients in this arm will receive the AMPLATZER PFO Occluder device
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013, United States
UCLA School of Medicine
Los Angeles, California, 90095, United States
Memorial Hospital
Colorado Springs, Colorado, 80909, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Medical Center of the Rockies
Fort Collins, Colorado, 80528, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
University of Iowa
Iowa City, Iowa, 52240, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70124, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
St. Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
St. Johns's Mercy Medical Center
St Louis, Missouri, 63141, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Children's Heart Center Las Vegas
Las Vegas, Nevada, 89109, United States
Mercy Hospital of Buffalo
Buffalo, New York, 14214, United States
University of Rochester Medical School
Rochester, New York, 14642-8679, United States
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, 17104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
The Methodist Hospital
Houston, Texas, 77030, United States
St. Mark's Hospital
Salt Lake City, Utah, 84124, United States
Intermountain Medical Center
Salt Lake City, Utah, 84143, United States
Inova Healthcare Services
Falls Church, Virginia, 22042, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Tobis JM, Charles A, Silberstein SD, Sorensen S, Maini B, Horwitz PA, Gurley JC. Percutaneous Closure of Patent Foramen Ovale in Patients With Migraine: The PREMIUM Trial. J Am Coll Cardiol. 2017 Dec 5;70(22):2766-2774. doi: 10.1016/j.jacc.2017.09.1105.
PMID: 29191325DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Global Clinical Affairs
- Organization
- St. Jude Medical
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2006
First Posted
July 21, 2006
Study Start
January 1, 2006
Primary Completion
February 1, 2015
Study Completion
December 1, 2015
Last Updated
July 30, 2020
Results First Posted
July 30, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share