Clinical trial NCT00355056: PREMIUM Migraine Trial
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Headaches
Patent Foramen Ovale
Keywords: Migraine
PFO
Migraine Headache
patent foramen ovale
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2006-07-21
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Primary Efficacy Endpoint - Percentage of Subjects With a 50% Reduction From Baseline in the Monthly Number of Migraine Attacks at 12 Months.
timeFrame: Baseline and months 10-12
measure: Primary Safety Endpoint - Device Related Serious Adverse Event (SAE)
timeFrame: Baseline through 12 months
Secondary outcomes:
measure: Change in Mean Migraine Days/Month
timeFrame: Baseline and months 10-12
measure: Percentage of Subjects With Successful PFO Closure at 12-months
timeFrame: Baseline and month 12
measure: Change in Migraine Disability Assessment (MIDAS) Score From Baseline to 12-months
timeFrame: 12 months
measure: Incidence of a 75% Reduction in Migraine Headache Attacks
timeFrame: 12 months
measure: Procedural Success
timeFrame: 12 months
measure: Long-Term Success
timeFrame: 12 months
measure: Incidence of All Adverse Events at 12-months
timeFrame: 12 months
measure: Incidence of Device-related Adverse Events
timeFrame: 12 months
measure: Incidence of a 95% Reduction in Migraine Headache Attacks
timeFrame: 12-months
Other outcomes:
measure: Change in Beck Depression Inventory (BDI) Scale
timeFrame: 12 months
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital & Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: UCLA School of Medicine
state: California
city: Colorado Springs
country: United States
facility: Memorial Hospital
state: Colorado
city: Englewood
country: United States
facility: Swedish Medical Center
state: Colorado
city: Fort Collins
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Cloud
country: United States
facility: St. Cloud Hospital
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: St. Johns's Mercy Medical Center
state: Missouri
city: Omaha
country: United States
facility: Alegent Health Bergan Mercy Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Children's Heart Center Las Vegas
state: Nevada
city: Buffalo
country: United States
facility: Mercy Hospital of Buffalo
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical School
state: New York
city: Harrisburg
country: United States
facility: Pinnacle Health Hospitals
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Salt Lake City
country: United States
facility: St. Mark's Hospital
state: Utah
city: Salt Lake City
country: United States
facility: Intermountain Medical Center
state: Utah
city: Falls Church
country: United States
facility: Inova Healthcare Services
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Intermountain Medical Center
name: Sherman Sorensen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas Jefferson University
name: Stephen Silberstein, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Jonathan Tobis, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Andrew Charles, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.