Since this Post Market Surveillance study is open (uncontrolled), it is possible – as well as the sponsor's responsibility – to actively monitor study data during the ongoing study. It is regulatory and scientifically permissible to summarize both efficacy and safety data.
As approximately fifty percent of the maximum patient population was recruited to the study, it was decided to carry out a follow-up of the data collected so far.
The purpose of the monitoring was a partial summary of the data – with a focus on some of the efficacy data – that were registered in the study from the start of inclusion until 26 May 2025. The study is still ongoing for the patients who are in the study, the recruitment of new patients has been discontinued because data compilation shows such satisfactory results that additional data cannot significantly improve the outcome.
The conclusion reported by the study's statisticians from the monitoring was as follows:
- Results for the primary endpoint/endpoint: "the reduction in moderate or severe headache days during the last four weeks of the six-week initial treatment period" statistically demonstrate a clinically relevant reduction in the number of headache days compared to baseline (four-week baseline measurement period). This confirms the overall results published for the PM007 study: https://www.neurology.org/doi/10.1212/WNL.0000000000210220.
- Regarding the main secondary endpoint: "Change from baseline in proportion of migraine days over 12 months from first treatment" also shows with statistical certainty a clinically relevant reduction in the number of days with migraine compared to baseline, over a reassuring period – where the study has so far collected a sufficient amount of data. The same applies to the reduction of headache days, but where the period of significant reduction is even longer.
“It is very gratifying that PM010 now with statistical significance further confirms the results from the PM007 study. This is of great importance in the work with the exit process," says Anders Weilandt, CEO of Chordate, and continues:
“This is a long study with twelve months of follow-up, and data is still being collected. An in-depth analysis is now underway to determine whether it is likely that such good results can be improved from a statistical perspective, or whether the data we have is sufficient to present a final picture of results.”
