N/A
N=230
PREMIUM Migraine Trial
Migraine Headaches · Patent Foramen Ovale
Bottom Line
View on ClinicalTrials.gov: NCT00355056 ↗Enrolled (actual)
230
Serious AEs
0.3%
Results posted
Jul 2020
Primary outcome: Primary: Primary Efficacy Endpoint - Percentage of Subjects With a 50% Reduction From Baseline in the Monthly Number of Migraine Attacks at 12 Months. — 32; 38 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sham Procedure (Other); AMPLATZER PFO Occluder (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Efficacy Endpoint - Percentage of Subjects With a 50% Reduction From Baseline in the Monthly Number of Migraine Attacks at 12 Months. |
32; 38 | — |
| PRIMARY Primary Safety Endpoint - Device Related Serious Adverse Event (SAE) |
0.49 | — |
| SECONDARY Change in Mean Migraine Days/Month |
2.0; 3.4 | — |
| SECONDARY Percentage of Subjects With Successful PFO Closure at 12-months |
82.7 | — |
| SECONDARY Change in Migraine Disability Assessment (MIDAS) Score From Baseline to 12-months |
-17; -22.6 | — |
| SECONDARY Incidence of a 75% Reduction in Migraine Headache Attacks |
16.5; 20.5 | — |
| SECONDARY Procedural Success |
94.3 | — |
| SECONDARY Long-Term Success |
80.8 | — |
| SECONDARY Incidence of All Adverse Events at 12-months |
93; 105 | — |
| SECONDARY Incidence of Device-related Adverse Events |
31.7 | — |
| SECONDARY Incidence of a 95% Reduction in Migraine Headache Attacks |
0.97; 8.55 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00355056). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.