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Published on: June 2, 2014
Migraine Headache and Patent Foramen Ovale: Observational Studies, the Randomized Clinical Trials, and the GORE
Robert J Sommer1, Barbara T Robbins1
1Department of Medicine, Division of Interventional Cardiology, Columbia University Medical Center, 161 Fort Washington Avenue, Room 624, New York, NY 10032, USA.
Abstract:
The pathophysiology of migraine remains poorly understood. Like most migraine preventive therapies, patent foramen ovale (PFO) closure was never intended for the treatment of migraine. After closure of PFO for other reasons, migraine symptom reduction/elimination was noted in some patients. Subsequent small trials failed to prove its benefit. There is significant evidence suggesting a platelet-mediated mechanism linking migraines to PFO. The GORE RELIEF Clinical Study is a randomized, blinded, placebo- and sham-controlled trial, currently enrolling. The study design is meant to optimize patient selection using thienopyridine responsiveness as an inclusion criterion.
Insights
Patent foramen ovale (PFO) closure may help reduce migraine symptoms, particularly in patients with platelet activation. The GORE RELIEF study is investigating this link further.
Area of Science:
- Neurology
- Cardiology
- Clinical Trials
Background:
- The exact causes of migraine pathophysiology are not fully understood.
- Patent foramen ovale (PFO) closure, while not initially for migraine treatment, has shown potential symptom reduction in some patients.
- Previous small trials have yielded inconclusive results regarding PFO closure for migraine prevention.
Purpose of the Study:
- To investigate the efficacy of PFO closure in reducing migraine symptoms.
- To explore a potential platelet-mediated mechanism linking PFO and migraines.
- To optimize patient selection for PFO closure trials using thienopyridine responsiveness.
Main Methods:
- The GORE RELIEF Clinical Study is a randomized, blinded, placebo- and sham-controlled trial.
- Patient selection is optimized by using thienopyridine responsiveness as an inclusion criterion.
- The study aims to provide robust data on PFO closure for migraine treatment.
Main Results:
- The study is currently enrolling patients.
- Results are pending, but the design aims to clarify the role of PFO in migraine.
- Investigating platelet-mediated mechanisms is a key component.
Conclusions:
- Further research is needed to establish PFO closure as a viable migraine treatment.
- Optimized patient selection may be crucial for future trial success.
- Understanding the underlying mechanisms is essential for developing effective migraine therapies.
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