The company also recently announced similar approval from the FDA for a similar trial in the US
In the trial, patients will undergo a closing of a small flap-like opening between the upper chambers of the heart, known as a patent foramen ovale (PFO), to see if the correction of the defect results in a reduction in both the number and severity of migraine headaches.
PFO is a heart defect found in more than 20% of adults. The PFO opening is normal in fetuses but usually closes shortly after birth. When it remains open, or “patent,” it allows blood to bypass the filtering system of the lungs. Substances such as small blood clots or chemicals in this unfiltered, non-regenerated blood traveling directly to the brain may trigger migraine attacks.
The study is expected to enroll approximately 120 patients at up to 8 medical centers in Europe. In addition to the approval in Switzerland, regulatory approval and enrollment in Italy, Germany, Poland and the UK is expected shortly.
“The causes of migraine are still not clearly understood. If the results of the trial are positive, PFO closure may prove to be the first treatment that eliminates the cause of one form of migraine, instead of treating only the symptoms.” stated Dr Heinrich Mattle, co-director of the Department of Neurology, University Hospital, Bern, Switzerland. “In addition to potentially resolving a major health concern in a specific group of patients, we may learn important factors in the origins of migraine that could advance treatment in other areas as well.”