Chordate Medical’s treatment method is currently being evaluated in a migraine study, but due to the pandemic, it has been paused for a fairly long time. Now, however, the company has been notified that the study can be resumed in March after the healthcare professionals at the study clinics in Finland have been vaccinated against Covid-19. The plan is now to recruit the last patient in the study in March, which means that Chordate Medical hopefully will complete the migraine study in July.
Chordate Medical has developed Kinetic Oscillation Stimulation (K.O.S), a treatment method used for chronic nasal congestion. However, doctors have noticed that the treatment method is also effective against migraine and therefore a clinical study is now being conducted with K.O.S in Finland and Germany on patients suffering from chronic migraine.
The hope is to be able to show that the K.O.S treatment leads to a significant reduction in the number of migraine days in patients with chronic migraine. In that case, it would mean that the patients do not need to rely on pharmaceuticals or botox injections, which in many cases lead to a number of unwanted side effects.
Glimmer of hope seen in October
In March, Chordate Medical announced that the company’s study activities had to be paused as a result of the Covid-19 pandemic. The migraine study was then paused for large parts of 2020 in order to allocate resources in healthcare to higher priorities and to avoid unnecessary care visits.
In October, however, Chordate Medical were able to get their hopes up when when they received a go-ahead from the study clinics in Finland to resume patient recruitment thanks to a new rapid antigen test for Covid-19.
About a week ago, Chordate Medical received the ethical approval required to introduce the new antigen test in the study protocol. However, the study management in Finland has now decided that the care staff at the Finnish study clinics must be fully vaccinated against Covid-19 before the study can be resumed, according to Chordate Medical’s CEO Anders Weilandt:
»Based on the fact that vaccine now is available, it was decided to protect the healthcare professionals in that way, which of course is much better from an infection control point of view. Even if it means another delay for the study.«
Vaccination against Covid-19 is required
It was the principal investigator for the Finnish clinics who gave the message that all care staff involved in the migraine study must be vaccinated against Covid-19 before the trial can resume. The decision was made based on the current rules for closing down non-emergency care activities in Finland.
The vaccination of the care staff has begun and is expected to have full effect by the beginning of March. Thereafter, patient recruitment can be resumed at the Finnish clinics to be able to conduct the last part of the migraine study. Chordate Medical estimates that the last patient will be included in the study in March.
The company’s previous forecast was that the last patient would complete the trial during the first quarter of 2021, but now the end-date is set to July instead. Anders Weilandt believes that they are well equipped to cope with this delay:
»It has probably not escaped anyone’s attention that the pandemic in recent months has affected everything and everyone – this also applies to our migraine study. However, the company is well equipped financially to overwinter this, although this further delay is of course not satisfactory.«
Germany started the study, Finland is completing it
The migraine study started already in 2018 at four neurology clinics in Germany. Since then, four Finnish clinics and another German clinic have been added to the list of study clinics.
However, the activities pertaining to the trial at the German clinics have been halted until further notice due to the spread of Covid-19. The five German clinics have worked diligently since the start of the study in 2018 and managed to recruit two thirds of the study population. Finland is expected to account for the remaining third of the approximately 140 patients in the study.
According to Anders Weilandt, the Finnish study clinics are well prepared to carry out the clinical trials effectively:
»The four Finnish clinics have long been well prepared to implement this in a short time, mainly through their organizational affiliation with a common database containing over 70,000 migraine patients«
Chordate Medical hopes for positive study results
The purpose of the migraine study is to evaluate the effect and safety of the K.O.S treatment, and the primary endpoint is to demonstrate a change in the number of days with headache after treatment with Chordates Medical’s method.
The study had previously generated positive results from an interim analysis of the first 53 patients included in the trial. In 2019, those results were reported, and the external data monitoring committee recommended that the study continue according to plan and that the number of patients in the study should not be changed.
Once the last patient has been treated, a shorter period of data processing and statistical analysis will take place before a final study result can be presented. Only then will we know if Chordate Medical’s K.O.S can help the large number of people suffering from chronic migraine.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.