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Trial record 1 of 1 for:    NCT00355056
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PREMIUM Migraine Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00355056
Recruitment Status : Completed
First Posted : July 21, 2006
Results First Posted : July 30, 2020
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Migraine Headaches
Patent Foramen Ovale
Interventions Other: Sham Procedure
Device: AMPLATZER PFO Occluder
Enrollment 230
Recruitment Details  
Pre-assignment Details 60 day baseline diary completion prior to randomization.
Arm/Group Title Sham Procedure Patent Foramen Ovale (PFO) Device Closure
Hide Arm/Group Description Did not receive the closure device, and treated with the current standard of care medical treatment. Patent foramen ovale (PFO) device Closure procedure using the AMPLATZER PFO Occluder device.
Period Title: Randomization Period
Started 107 123
Completed 103 117
Not Completed 4 6
Reason Not Completed
Early Termination             4             6
Period Title: Optional Patent Foramen Ovale Closure
Started 0 [1] 87 [2]
Completed 0 84
Not Completed 0 3
[1]
A sham procedure was not part of this period.
[2]
Participants who completed Sham Procedure randomization Arm were eligible. 87/103 consented.
Arm/Group Title Sham Procedure PFO Device Closure Total
Hide Arm/Group Description Participants 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 will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and undergo PFO device closure procedure with the AMPLATZER PFO Occluder. Total of all reporting groups
Overall Number of Baseline Participants 107 123 230
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants 123 participants 230 participants
43.72  (10.16) 42.75  (10.27) 43.20  (10.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 123 participants 230 participants
Female
95
  88.8%
110
  89.4%
205
  89.1%
Male
12
  11.2%
13
  10.6%
25
  10.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 107 participants 123 participants 230 participants
107 123 230
International Classification of Headache Disorders (ICH)   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 107 participants 123 participants 230 participants
Migraine with Aura (ICH) 71 80 151
Migraine without Aura (ICH) 83 102 185
Migraine with and without Aura 47 58 105
[1]
Measure Description: Participants can have more than one International Classification of Headache Disorder, which is why the sum of the three categories exceeds the overall number of baseline participants.
1.Primary Outcome
Title Primary Efficacy Endpoint - Percentage of Subjects With a 50% Reduction From Baseline in the Monthly Number of Migraine Attacks at 12 Months.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sham Procedure PFO Device Closure
Hide Arm/Group Description:
Did not receive the closure device, and treated with the current standard of care medical treatment.
PFO device Closure procedure using the AMPLATZER PFO Occluder device.
Overall Number of Participants Analyzed 103 117
Measure Type: Number
Unit of Measure: percentage of subjects
32 38
2.Primary Outcome
Title Primary Safety Endpoint - Device Related Serious Adverse Event (SAE)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title PFO Device Closure
Hide Arm/Group Description:
PFO device Closure procedure using the AMPLATZER PFO Occluder device.
Overall Number of Participants Analyzed 205
Measure Type: Number
Number (99% Confidence Interval)
Unit of Measure: percentage of participants
0.49
(0.01 to 2.69)
3.Secondary Outcome
Title Change in Mean Migraine Days/Month
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham Procedure PFO Device Closure
Hide Arm/Group Description:
Sham Procedure and treated only with current standard of care medical treatment.
Patients in this arm received the AMPLATZER PFO Occluder device
Overall Number of Participants Analyzed 103 117
Mean (Standard Deviation)
Unit of Measure: Migraine days per month
2.0  (5.0) 3.4  (4.4)
4.Secondary Outcome
Title Percentage of Subjects With Successful PFO Closure at 12-months
Hide Description Successful Closure by Core Lab Adjudicated Transcranial Doppler (TCD) Grade <= 2
Time Frame Baseline and month 12
Hide Outcome Measure Data
Hide Analysis Population Description
117 device subjects completed the 12 month visit. Only 104 had TCDs that were able to be adjudicated. Of the 13 device subjects with unadjudicated TCDs, 4 did not have valsalva data and 9 did not have TCD data available for various reasons.
Arm/Group Title PFO Closure
Hide Arm/Group Description:
Device group subjects who had a Core Lab adjudicated TCD grade at Valsalva of less than or equal to 2 at 12-months.
Overall Number of Participants Analyzed 104
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
82.7
(74 to 89)
5.Secondary Outcome
Title Change in Migraine Disability Assessment (MIDAS) Score From Baseline to 12-months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
101 participants in the sham group and 116 subjects in the PFO device closure group had both baseline and 12-month MIDAS scores available to perform the analysis.
Arm/Group Title Sham Procedure PFO Device Closure
Hide Arm/Group Description:
Sham Procedure and treated only with current standard of care medical treatment.
Patients in this arm received the AMPLATZER PFO Occluder device
Overall Number of Participants Analyzed 101 116
Mean (Standard Deviation)
Unit of Measure: units on a scale
-17  (36) -22.6  (32.9)
6.Secondary Outcome
Title Incidence of a 75% Reduction in Migraine Headache Attacks
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were included in the analysis were followed for 1-year, have 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.
Arm/Group Title Sham Procedure PFO Device Closure
Hide Arm/Group Description:
Sham Procedure and treated only with current standard of care medical treatment.
Patients in this arm received the AMPLATZER PFO Occluder device
Overall Number of Participants Analyzed 103 117
Measure Type: Number
Unit of Measure: percentage of participants
16.5 20.5
7.Secondary Outcome
Title Procedural Success
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Device group subjects who were implanted with the study device and experienced no serious device or procedure-related adverse events.
Arm/Group Title PFO Closure
Hide Arm/Group Description:
Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and undergo PFO device closure procedure with the AMPLATZER PFO Occluder.
Overall Number of Participants Analyzed 123
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
94.3
(88.6 to 97.7)
8.Secondary Outcome
Title Long-Term Success
Hide 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
Hide Outcome Measure Data
Hide Analysis Population 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. 117 device subjects completed the 12 month visit. Only 104 had TCDs that were able to be adjudicated.
Arm/Group Title PFO Closure
Hide Arm/Group Description:
Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and undergo PFO device closure procedure with the AMPLATZER PFO Occluder.
Overall Number of Participants Analyzed 104
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
80.8
(71.9 to 87.8)
9.Secondary Outcome
Title Incidence of All Adverse Events at 12-months
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who experienced an adverse event at or before 12-months post-procedure
Arm/Group Title Sham Procedure PFO Device Closure
Hide Arm/Group Description:
Sham Procedure and treated only with current standard of care medical treatment.
Patients in this arm received the AMPLATZER PFO Occluder device
Overall Number of Participants Analyzed 107 123
Measure Type: Number
Unit of Measure: participants
93 105
10.Secondary Outcome
Title Incidence of Device-related Adverse Events
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who experienced a device-related adverse event, as adjudicated by the Data Safety and Monitoring Board (DSMB), at or before 12-months post-procedure.
Arm/Group Title PFO Closure
Hide Arm/Group Description:
Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and undergo PFO device closure procedure with the AMPLATZER PFO Occluder.
Overall Number of Participants Analyzed 123
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
31.7
(23.6 to 40.7)
11.Secondary Outcome
Title Incidence of a 95% Reduction in Migraine Headache Attacks
Hide Description [Not Specified]
Time Frame 12-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham Procedure PFO Device Closure
Hide Arm/Group Description:
Sham Procedure and treated only with current standard of care medical treatment.
Patients in this arm received the AMPLATZER PFO Occluder device
Overall Number of Participants Analyzed 103 117
Measure Type: Number
Unit of Measure: percentage of participants
0.97 8.55
12.Other Pre-specified Outcome
Title Change in Beck Depression Inventory (BDI) Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
101 participants in the sham group and 116 subjects in the PFO device closure group had both baseline and 12-month BDI scores available to perform the analysis.
Arm/Group Title Sham Procedure PFO Device Closure
Hide Arm/Group Description:
Sham Procedure and treated only with current standard of care medical treatment.
Patients in this arm received the AMPLATZER PFO Occluder device
Overall Number of Participants Analyzed 101 116
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.3  (7.1) -2.1  (6.5)
13.Post-Hoc Outcome
Title Responder Rate for Subjects in Whom Majority of Attacks Were With Aura
Hide Description The term "majority" in "majority of migraine attacks included aura" was defined by the Neurologist (>50%) at the time of randomization based on a review of the subject's study baseline headache diary and medical history.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PFO Device Closure Sham Procedure
Hide Arm/Group Description:
Patients in this arm received the AMPLATZER PFO Occluder device.
Sham Procedure and treated only with current standard of care medical treatment.
Overall Number of Participants Analyzed 39 40
Measure Type: Number
Unit of Measure: percentage of subjects
48.7 22.5
14.Post-Hoc Outcome
Title Percentage of Subjects With Migraine With Aura Determined to Have a Complete Cessation of Migraine Attacks According to the International Headache Society (IHS)
Hide Description Complete Cessation of Migraine Attacks, baseline diary compared to months 10-12
Time Frame Baseline through months 10-12
Hide Outcome Measure Data
Hide Analysis Population Description
6 PFO Device Closure Subjects and 3 Sham Procedure Subjects with Aura do not have 12-month follow-up data available.
Arm/Group Title PFO Device Closure Sham Procedure
Hide Arm/Group Description:
Patients in this arm received the AMPLATZER PFO Occluder device.
Sham Procedure and treated only with current standard of care medical treatment.
Overall Number of Participants Analyzed 74 68
Measure Type: Number
Unit of Measure: percentage of subjects
10.8 1.5
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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PFO Device Closure Sham Procedure Optional PFO Closure
Hide Arm/Group Description PFO device Closure procedure using the AMPLATZER PFO Occluder device. Did not receive the closure device, and treated with the current standard of care medical treatment. Subjects randomized to the sham arm and completed their 12-month follow up visit were given the option of PFO closure with the Amplatzer PFO Occluder.
All-Cause Mortality
PFO Device Closure Sham Procedure Optional PFO Closure
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
PFO Device Closure Sham Procedure Optional PFO Closure
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/123 (0.81%)      0/107 (0.00%)      0/87 (0.00%)    
Cardiac disorders       
Transient atrial fibrillation after device placement  1/123 (0.81%)  1 0/107 (0.00%)  0 0/87 (0.00%)  0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PFO Device Closure Sham Procedure Optional PFO Closure
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   119/123 (96.75%)      103/107 (96.26%)      68/87 (78.16%)    
Cardiac disorders       
Arterial Hypertension/Hypertension  8/123 (6.50%)  9 4/107 (3.74%)  4 2/87 (2.30%)  2
Palpitations  30/123 (24.39%)  31 16/107 (14.95%)  18 12/87 (13.79%)  12
Gastrointestinal disorders       
Abdominal Pain  17/123 (13.82%)  18 14/107 (13.08%)  14 1/87 (1.15%)  1
Diarrhea  7/123 (5.69%)  7 4/107 (3.74%)  4 0/87 (0.00%)  0
General disorders       
Nausea  10/123 (8.13%)  11 9/107 (8.41%)  9 1/87 (1.15%)  1
Fatigue/Generalized Fatigue  4/123 (3.25%)  5 10/107 (9.35%)  11 0/87 (0.00%)  0
Musculoskeletal Pain  21/123 (17.07%)  22 9/107 (8.41%)  10 0/87 (0.00%)  0
Anxiety  7/123 (5.69%)  7 5/107 (4.67%)  5 1/87 (1.15%)  1
Rash  10/123 (8.13%)  11 4/107 (3.74%)  4 1/87 (1.15%)  1
Pain  7/123 (5.69%)  9 8/107 (7.48%)  9 1/87 (1.15%)  1
Dizziness  6/123 (4.88%)  6 9/107 (8.41%)  12 2/87 (2.30%)  2
Sinusitis  29/123 (23.58%)  35 23/107 (21.50%)  40 7/87 (8.05%)  7
Chest Pain  22/123 (17.89%)  28 13/107 (12.15%)  13 13/87 (14.94%)  13
Bruise/Purpura Simplex  20/123 (16.26%)  21 27/107 (25.23%)  31 10/87 (11.49%)  10
Viral Syndrome  9/123 (7.32%)  9 3/107 (2.80%)  5 0/87 (0.00%)  0
Low Back Pain  7/123 (5.69%)  8 3/107 (2.80%)  3 1/87 (1.15%)  1
Back Pain  8/123 (6.50%)  8 11/107 (10.28%)  12 5/87 (5.75%)  5
Mid-Sternal Chest Pressure  6/123 (4.88%)  7 0/107 (0.00%)  0 1/87 (1.15%)  1
Headache  6/123 (4.88%)  6 7/107 (6.54%)  7 2/87 (2.30%)  2
Depression  3/123 (2.44%)  3 6/107 (5.61%)  7 1/87 (1.15%)  1
Dyspnea  6/123 (4.88%)  6 7/107 (6.54%)  7 2/87 (2.30%)  2
Sore Throat  4/123 (3.25%)  5 7/107 (6.54%)  7 1/87 (1.15%)  1
Infections and infestations       
Common cold/Upper Respiratory Tract Infection  29/123 (23.58%)  35 28/107 (26.17%)  39 3/87 (3.45%)  3
Urinary Tract Infection  16/123 (13.01%)  17 13/107 (12.15%)  15 4/87 (4.60%)  4
Respiratory, thoracic and mediastinal disorders       
Cough  8/123 (6.50%)  9 4/107 (3.74%)  4 0/87 (0.00%)  0
Vascular disorders       
Vascular Access Site Complication Pain  22/123 (17.89%)  22 12/107 (11.21%)  13 9/87 (10.34%)  9
Vascular Access Site Complication Hematoma  8/123 (6.50%)  8 12/107 (11.21%)  12 6/87 (6.90%)  6
Vascular Access Site Complication Bruise  8/123 (6.50%)  8 3/107 (2.80%)  3 3/87 (3.45%)  3
Vascular Access Site Complication Bleeding  5/123 (4.07%)  5 3/107 (2.80%)  3 6/87 (6.90%)  6
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Global Clinical Affairs
Organization: St. Jude Medical
Phone: 818-493-3648
EMail: aoza@sjm.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT00355056    
Other Study ID Numbers: AGA-010
First Submitted: July 19, 2006
First Posted: July 21, 2006
Results First Submitted: May 2, 2016
Results First Posted: July 30, 2020
Last Update Posted: July 30, 2020