search
Back to results

PREMIUM Migraine Trial

Primary Purpose

Migraine Headaches, Patent Foramen Ovale

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sham Procedure
AMPLATZER PFO Occluder
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Headaches focused on measuring Migraine, PFO, Migraine Headache, patent foramen ovale

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Hospital & Medical Center
  • UCLA School of Medicine
  • Memorial Hospital
  • Swedish Medical Center
  • Medical Center of the Rockies
  • Washington Hospital Center
  • University of Iowa
  • University of Kentucky
  • Ochsner Clinic Foundation
  • Tufts Medical Center
  • Massachusetts General Hospital
  • William Beaumont Hospital
  • Abbott Northwestern Hospital
  • Mayo Clinic
  • St. Cloud Hospital
  • Washington University School of Medicine
  • St. Johns's Mercy Medical Center
  • Alegent Health Bergan Mercy Medical Center
  • Children's Heart Center Las Vegas
  • Mercy Hospital of Buffalo
  • University of Rochester Medical School
  • Pinnacle Health Hospitals
  • Thomas Jefferson University
  • The Methodist Hospital
  • St. Mark's Hospital
  • Intermountain Medical Center
  • Inova Healthcare Services
  • University of Washington Medical Center
  • St. Luke's Medical Center
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Medical Management

PFO Closure

Arm Description

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).

Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and undergo PFO device closure procedure with the AMPLATZER PFO Occluder.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Change in Mean Migraine Days/Month
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
Successful Closure by Core Lab Adjudicated Transcranial Doppler (TCD) Grade <= 2
Change in Migraine Disability Assessment (MIDAS) Score From Baseline to 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
Procedural Success
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
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
Incidence of Device-related Adverse Events
Incidence of a 95% Reduction in Migraine Headache Attacks

Full Information

First Posted
July 19, 2006
Last Updated
July 14, 2020
Sponsor
Abbott Medical Devices
search

1. Study Identification

Unique Protocol Identification Number
NCT00355056
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headaches, Patent Foramen Ovale
Keywords
Migraine, PFO, Migraine Headache, patent foramen ovale

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medical Management
Arm Type
Sham Comparator
Arm Description
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).
Arm Title
PFO Closure
Arm Type
Experimental
Arm Description
Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and undergo PFO device closure procedure with the AMPLATZER PFO Occluder.
Intervention Type
Other
Intervention Name(s)
Sham Procedure
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
AMPLATZER PFO Occluder
Intervention Description
Patients in this arm will receive the AMPLATZER PFO Occluder device
Primary Outcome Measure Information:
Title
Primary Efficacy Endpoint - Percentage of Subjects With a 50% Reduction From Baseline in the Monthly Number of Migraine Attacks at 12 Months.
Description
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).
Time Frame
Baseline and months 10-12
Title
Primary Safety Endpoint - Device Related Serious Adverse Event (SAE)
Description
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.
Time Frame
Baseline through 12 months
Secondary Outcome Measure Information:
Title
Change in Mean Migraine Days/Month
Description
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.
Time Frame
Baseline and months 10-12
Title
Percentage of Subjects With Successful PFO Closure at 12-months
Description
Successful Closure by Core Lab Adjudicated Transcranial Doppler (TCD) Grade <= 2
Time Frame
Baseline and month 12
Title
Change in Migraine Disability Assessment (MIDAS) Score From Baseline to 12-months
Description
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.
Time Frame
12 months
Title
Incidence of a 75% Reduction in Migraine Headache Attacks
Time Frame
12 months
Title
Procedural Success
Description
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.
Time Frame
12 months
Title
Long-Term Success
Description
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.
Time Frame
12 months
Title
Incidence of All Adverse Events at 12-months
Time Frame
12 months
Title
Incidence of Device-related Adverse Events
Time Frame
12 months
Title
Incidence of a 95% Reduction in Migraine Headache Attacks
Time Frame
12-months
Other Pre-specified Outcome Measures:
Title
Change in Beck Depression Inventory (BDI) Scale
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherman Sorensen, M.D.
Organizational Affiliation
Intermountain Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Silberstein, M.D.
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan Tobis, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Charles, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Hospital & Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Memorial Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Swedish Medical Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Medical Center of the Rockies
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52240
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70124
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
St. Cloud Hospital
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Johns's Mercy Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Alegent Health Bergan Mercy Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Children's Heart Center Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Mercy Hospital of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
Facility Name
University of Rochester Medical School
City
Rochester
State/Province
New York
ZIP/Postal Code
14642-8679
Country
United States
Facility Name
Pinnacle Health Hospitals
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
St. Mark's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Intermountain Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Inova Healthcare Services
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29191325
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.
Results Reference
derived

Learn more about this trial

PREMIUM Migraine Trial

We'll reach out to this number within 24 hrs