Chordate Medical Holding AB (publ) (“Chordate”) announces today that the first seven patients have been included in the company’s post-Market Study PM010. The seven patients have been enrolled by the study at neurology clinics in Hull, Glasgow, Frankfurt, Essen, and Jerusalem.
“All participating clinics are led by reputable specialists, and it is satisfying that the first patients are now enrolled. The PM010 study is part of the regulatory requirement for the CE marking of migraine treatment but also holds significant importance in providing information to treating physicians about how often the treatment needs to be administered to different types of patients”, says Anders Weilandt, CEO of Chordate.
The PM010 study is an ongoing, open post-marketing clinical follow-up investigation to follow long-term performance and safety of Chordate Medical’s preventive migraine treatment Ozilia® in subjects with chronic migraine during regular clinical treatment. The study will recruit 200 subjects and will be conducted at approximately 15 clinics in four European countries, the follow-up is 12 months. Data from this open study will be reported in intervals and used to fine-tune recommendations for the clinical treatment regime.