PREMIUM Migraine Trial

Completed · Not applicable · Has a placebo group

Conditions studied: Migraine Headaches, Patent Foramen Ovale

In brief

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.

Key facts

Study ID

NCT00355056

Run by

Abbott Medical Devices

People needed

230

Starts

2006-01-01

Expected to finish

2015-12-01

Last updated by the study team

2020-07-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• St. Joseph's Hospital & Medical Center — Phoenix, Arizona, United States
• UCLA School of Medicine — Los Angeles, California, United States
• Memorial Hospital — Colorado Springs, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Medical Center of the Rockies — Fort Collins, Colorado, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kentucky — Lexington, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• St. Cloud Hospital — Saint Cloud, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• St. Johns's Mercy Medical Center — St Louis, Missouri, United States
• Alegent Health Bergan Mercy Medical Center — Omaha, Nebraska, United States
• Children's Heart Center Las Vegas — Las Vegas, Nevada, United States
• Mercy Hospital of Buffalo — Buffalo, New York, United States
• University of Rochester Medical School — Rochester, New York, United States
• Pinnacle Health Hospitals — Harrisburg, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• The Methodist Hospital — Houston, Texas, United States
• St. Mark's Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.