The ethics committee of the National Health Service in the UK has approved the study design for Chordate Medical's upcoming migraine study PM009, which aims to evaluate the efficacy of K.O.S in the preventive treatment of chronic migraine on subjects not responding to treatment with monoclonal antibodies targeting the CGRP pathway.
Approval of the study design was the final formal obstacle for study to be initiated at King's College London. Chordate estimates that the screening process at the earliest can start in the beginning of July 2023.
"PM009 is an important and exciting study with significant potential for us. Any level of positive outcome will likely mean a great opportunity for our company as this challenged patient group has very few options left," says Anders Weilandt, CEO of Chordate.
The PM009 study is a planned, open pilot study to evaluate the efficacy of intranasal kinetic oscillation stimulation (K.O.S) in the preventive treatment of chronic migraine on subjects not responding to treatment with monoclonal antibodies targeting the CGRP pathway. The study aimed to include 25-30 subjects to investigate the reduction of headache days using the KOS technology. The study is conducted at King’s College in London with three to four referring clinics assisting with the recruitment of suitable subjects for the study.