Chordate Medical’s PM007 clinical trial show that treatment with Kinetic Oscillation Stimulation is an effective and safe option for the preventative treatment of chronic migraine. Dr Jan Hoffmann, principal investigator for the study, recently presented the primary outcomes at the American Headache Society Scientific Meeting. In addition, a case study has been presented at a congress in Berlin showing encouraging treatment results for a 45-year-old woman from the PM007 study. BioStock talked to Dr Hoffmann about his experience from the study and the K.O.S. treatment.

Chordate Medical has developed Kinetic Oscillation Stimulation (K.O.S.), a neuromodulating and drug-free treatment technology for chronic migraine and chronic nasal congestion (rhinitis). K.O.S. is a medical device that is inserted into the patient’s nasal cavity, where it induces an autonomic response by vibrations.

Last year, Chordate Medical concluded a study (PM007) on migraine patients showing that K.O.S. significantly reduces the monthly headache days (MHD) with moderate to severe intensity. In June, the results were presented at two congresses – American Headache Society Scientific Meeting and The German Migraine and Headache Society’s congress.

Presentation at American Headache Society Scientific Meeting

On June 17, Dr Jan Hoffmann from King’s College London presented the results at the Annual Scientific Meeting of the American Headache Society, which is the largest scientific meeting in the US dedicated exclusively to healthcare professionals and researchers specialised in headache disorders. This year’s edition of the meeting was arranged in Austin, Texas, and was mainly visited by specialists from the US, but also international experts.

Dr Hoffmann’s lecture was attended by approximately 300 migraine specialists. CEO Anders Weilandt also attended the event to meet with industry professionals and researchers. According to him, Dr Hoffmann’s presentation was received with great interest, judging by the subsequent questions from the audience.

Case study presented in Berlin

In addition, co-author Dr Charly Gaul presented the study results at The German Migraine and Headache Society’s congress in Berlin on June 30th. Dr Tim P Jürgens was also there to present a case study from Dr Florian Rimmele on one of the participating patients, a 45-year-old woman with a long history of chronic migraine with visual auras.

In her case, established migraine prophylactic medication was not possible to use due to her other medical conditions, especially systemic mastocytosis. K.O.S. proved to be a well-tolerated and long-lasting prophylactic for this patient. Her number of monthly migraine days decreased significantly, from 18 to 8 days per month. The positive effect of the K.O.S. treatment lasted for four months without further treatment sessions. Read the case study here.

The study results in detail

The PM007 clinical trial was conducted to assess the efficacy of intranasal treatment with K.O.S. for the preventive treatment for chronic migraine. 132 patients with chronic migraine were randomised to either receive intranasal stimulation with K.O.S. (85 Hz, 80 mbar) or sham stimulation (no vibration) once per week for 10 minutes per nostril over 6 weeks.

The patients who received active K.O.S. treatment demonstrated an average reduction of circa 3.5 migraine days/month. The number of headache day were also reduced by about the same number of days in the observation period, demonstrating a sustained treatment effect in the 4 weeks follow-up period. The active treatment group had significantly better results compared to the sham group for both migraine and headache days. The study also showed that the treatment was well-tolerated with no severe adverse events, indicating a favourable side effect profile.

Interview with Dr Hoffmann

BioStock contacted Dr Hoffmann to get to know more about the results from the PM007 clinical trial.

First of all, why do we need alternatives and complements to today’s treatments for chronic migraine?

– Despite having a range of effective treatment options for chronic migraine there is still a significant unmet need for patients with migraine.

– The main reasons for this unmet need are the facts that all currently available preventives are only effective in a certain percentage of migraine patients, they frequently cause significant side effects that can have an important additional impact on the quality of life, and the problem that some of these medications are contraindicated in the presence of some of the most common comorbidities such as for example depression. In particular because of the potential side effects and negative past experience with systemic preventive treatments, patients with migraine are frequently interested in non-pharmacological treatment alternatives.

»Despite having a range of effective treatment options for chronic migraine there is still a significant unmet need for patients with migraine. […] Patients with migraine are frequently interested in non-pharmacological treatment alternatives.«

What were the most interesting findings in the PM007 clinical trial with K.O.S. according to you? 

­– Aside of the clinical efficacy, in my opinion the two most interesting findings are the sustained treatment effect throughout the follow-up period and the favourable side effect profile.

Could you explain how K.O.S. affects the autonomic nervous system and reduces the number of headache days?

– We do not yet understand in detail the exact mechanisms underlying the treatment effect of K.O.S. in chronic migraine. However, as kinetic oscillation of the nasal cavity elicits trigeminal cranial autonomic symptoms such as lacrimation (tear-flow), given the preclinical and clinical evidence that modulation of the parasympathetic outflow which mediates these symptoms can be favourable in the context of migraine, and the anatomical proximity to the relevant structures such as the sphenopalatine ganglion, it seems likely that K.O.S. may act by influencing the parasympathetic outflow thereby modulating the so-called trigemino-autonomic reflex which in turn could lead to the observed reduction in headache frequency.

What were the overall reactions and thoughts on K.O.S. at the congress?  

– In general, the audience was very interested in the findings which was reflected in the questions and discussions that followed the presentation. For the attendees, the findings were of great interest as K.O.S. is based on an entirely new and non-pharmacological treatment concept. In addition, in contrast to some of the other available neuromodulation techniques, the efficacy of K.O.S. was demonstrated by a sham-controlled trial and not just by an open-label study. In this context, considering the non-pharmacological nature of the treatment and the unmet need from a patients’ perspective, K.O.S. clearly raised a significant interest among attending clinicians.

»For the attendees, the findings were of great interest as K.O.S. is based on an entirely new and non-pharmacological treatment concept. In addition, in contrast to some of the other available neuromodulation techniques, the efficacy of K.O.S. was demonstrated by a sham-controlled trial and not just by an open-label study.«

In addition, a recently presented case study demonstrates the potential of K.O.S. in patients who, for various reasons, cannot medicate with drugs typically prescribed for chronic migraines. Why is K.O.S. a valuable treatment for this kind of patient?

– Because of its non-pharmacological mechanism and the resulting favourable side effect profile, K.O.S. provides an alternative for patients for which other treatments were ineffective or not tolerated as well as for patients who prefer a non-pharmacological treatment approach. The reported patient reflects this situation and highlights the importance of both the current unmet need and the positive impact K.O.S. can have on a patient’s quality of life.

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