Migraine HeadachesNCT00355056

PREMIUM Migraine Trial

A study testing AMPLATZER PFO Occluder in people with Migraine Headaches and Patent Foramen Ovale, run by Abbott Medical Devices at 30 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Migraine Headaches, Patent Foramen Ovale
What is being tested?: AMPLATZER PFO Occluder
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 230 participants
Where: 30 sitesUnited States
Study dates: Jan 2006to Dec 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

United States30 sites

Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Mercy Hospital of Buffalo
Buffalo, New York, 14214
Memorial Hospital
Colorado Springs, Colorado, 80909
Swedish Medical Center
Englewood, Colorado, 80113
Inova Healthcare Services
Falls Church, Virginia, 22042
Medical Center of the Rockies
Fort Collins, Colorado, 80528
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, 17104
The Methodist Hospital
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52240
Children's Heart Center Las Vegas
Las Vegas, Nevada, 89109
University of Kentucky
Lexington, Kentucky, 40536
UCLA School of Medicine
Los Angeles, California, 90095
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Ochsner Clinic Foundation
New Orleans, Louisiana, 70124
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester Medical School
Rochester, New York, 14642-8679
William Beaumont Hospital
Royal Oak, Michigan, 48073
St. Cloud Hospital
Saint Cloud, Minnesota, 56303
St. Mark's Hospital
Salt Lake City, Utah, 84124
Intermountain Medical Center
Salt Lake City, Utah, 84143
University of Washington Medical Center
Seattle, Washington, 98195
Washington University School of Medicine
St Louis, Missouri, 63110
St. Johns's Mercy Medical Center
St Louis, Missouri, 63141
Washington Hospital Center
Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

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.

Read the 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.

Conditions: Migraine Headaches, Patent Foramen Ovale
Being tested: Sham Procedure, AMPLATZER PFO Occluder
Keywords: Migraine, PFO, Migraine Headache, patent foramen ovale
Medical subject headings: Migraine Disorders, Foramen Ovale, Patent

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sham ProcedureOther
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.
AMPLATZER PFO OccluderDevice
Patients in this arm will receive the AMPLATZER PFO Occluder device

Study groups in NCT00355056
Study group	Role	What they receive
Medical Management	Sham comparator	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). Receives: Other: Sham Procedure
PFO Closure	Experimental	Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and undergo PFO device closure procedure with the AMPLATZER PFO Occluder. Receives: Device: AMPLATZER PFO Occluder

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: Baseline through 12 months

Secondary outcomes (9)

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.
Measured: Baseline and months 10-12
Percentage of Subjects With Successful PFO Closure at 12-months
Successful Closure by Core Lab Adjudicated Transcranial Doppler (TCD) Grade <= 2
Measured: Baseline and month 12
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.
Measured: 12 months
Incidence of a 75% Reduction in Migraine Headache Attacks
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Incidence of All Adverse Events at 12-months
Measured: 12 months
Incidence of Device-related Adverse Events
Measured: 12 months
Incidence of a 95% Reduction in Migraine Headache Attacks
Measured: 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2006Dec 2015

First posted21 Jul 2006 (estimated)
Study startJan 2006
Primary completionFeb 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Migraine HeadachesStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 230 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00355056
Sponsor's protocol ID: AGA-010
Status last verified: Jul 2020
First submitted: 19 Jul 2006
Last updated: 30 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 29191325

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00355056
Acronym / sponsor ID: AGA-010
Conditions: Migraine Headaches, Patent Foramen Ovale
Keywords: Migraine, PFO, Migraine Headache, patent foramen ovale
Study type: Interventional
Recruitment status: Completed
Enrolment: 230 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Jan 2006
Primary completion: Feb 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 21 Jul 2006 (estimated)
Results: Posted 30 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Medical Management	Sham comparator	Other: Sham ProcedureWill 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	Experimental	Device: AMPLATZER PFO OccluderWill undergo Intracardiac Echo (ICE) in cardiac catheterization lab and undergo PFO device closure procedure with the AMPLATZER PFO Occluder.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sham ProcedureWill 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.	Other	Medical Management
AMPLATZER PFO OccluderPatients in this arm will receive the AMPLATZER PFO Occluder device	Device	PFO Closure

Primary outcome

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.

9 secondary outcomes

Change in Mean Migraine Days/Month
Time frame: Baseline and months 10-12
Percentage of Subjects With Successful PFO Closure at 12-months
Time frame: Baseline and month 12
Change in Migraine Disability Assessment (MIDAS) Score From Baseline to 12-months
Time frame: 12 months
Incidence of a 75% Reduction in Migraine Headache Attacks
Time frame: 12 months
Procedural Success
Time frame: 12 months
Long-Term Success
Time frame: 12 months
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

Results and safety

Results posted to the registry on 30 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sham Procedure	107	103
Patent Foramen Ovale (PFO) Device Closure	123	117

Primary outcome: 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. Number. Unit: percentage of subjects

Measure	Sham Procedure n = 103	PFO Device Closure n = 117
Value	32	38

Population analysed: Participants included in the analysis were followed for 1-year, had Clinical Event Committee (CEC) adjudicated headache diaries, had greater than or equal to 60% diary compliance during the treatment phase (10-12 months) and were not treatment failures.

Primary outcome: Primary Safety Endpoint - Device Related Serious Adverse Event (SAE)

Time frame: Baseline through 12 months. Number (99% Confidence Interval). Unit: percentage of participants

Measure	PFO Device Closure n = 205
Value	0.49 (0.01 to 2.69)

Population analysed: All enrolled subjects who received the device (randomized and Optional PFO Closure group). 5 subjects were considered to have insufficient follow-up and were therefore excluded from the analysis.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events were collected from the time of signing informed consent until the 12-month follow-up visit. After the 12-month follow-up visit, serious adverse events and/or device-related events were collected until completion of study requirements.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PFO Device Closure	1 of 123 (0.8%)	119 of 123 (96.7%)	Not reported
Sham Procedure	0 of 107 (0%)	103 of 107 (96.3%)	Not reported
Optional PFO Closure	0 of 87 (0%)	68 of 87 (78.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29191325Tobis 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.
Individual participant dataSharing planned: No

Related trials for Migraine Headaches

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sherman Sorensen, M.D. principal investigator

Intermountain Health Care, Inc.

Stephen Silberstein, M.D. principal investigator

Thomas Jefferson University

Jonathan Tobis, M.D. principal investigator

University of California, Los Angeles

30 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AMPLATZER PFO Occluder in people with Migraine Headaches and Patent Foramen Ovale, run by Abbott Medical Devices at 30 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00355056, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.