The clinical post-market study, PM010, for Chordate’s migraine treatment Ozilia® (formerly K.O.S) has started. The study is designed for 200 patients across up to 15 clinics in the United Kingdom, Germany, Italy, and Israel. It is an open observational study with a 12-month follow-up.
Post-Market Surveillance, a part of the regulatory requirements for the CE marking of the migraine product, is crucial for providing information to treating physicians on how often the treatment needs to be administered to different types of patients.
The first clinic to start is Hull University Teaching Hospitals NHS Trust in Hull, UK, where Professor Fayyaz Ahmed is the investigator in the study, which has begun recruiting approximately 10 patients. Ethical approvals and agreements with other clinics and countries are in place.
“It is satisfying that we are now underway with PM010 after hard work in selecting the right clinics and managing ethics and study agreements in each region where the study will be conducted. It has been important to involve clinics with a relatively large patient flow, focusing on normal clinical operations rather than study-related activities,” says Jan Hermansson, Medical Director at Chordate.
Chordate Medical’s Ozilia® (formerly K.O.S) migraine treatment is a new and alternative method for chronic migraine. Ozilia® has been CE-marked since May 2021 for the preventive treatment of chronic migraine in adults over 18 years old and is marketed in selected European markets and Israel.