As this Post Market Surveillance study is open (uncontrolled) it is possible – as well as the responsibility of the sponsor – to actively monitor the study data during the ongoing trial. It is regulatory and scientifically permitted to summarise both efficacy and safety data.
At approximately twenty-five percent of the population recruited to the study it was decided to perform a monitoring session of the data collected so far.
The purpose of the monitoring was to summarize parts of the data – focusing on some of the efficacy data – recorded in the study from start of inclusion until August 23, 2024. The study is still ongoing, and recruitment of patients is not affected by this data summary.
The conclusion reported by the study statistician was as follows:
- Results regarding the primary endpoint/objective: the “reduction of days with moderate or severe headache” are promising.
- The sensitivity analysis of the primary objective shows results in the same magnitude/direction as the main analysis.
- The major secondary efficacy objective: “Change from Baseline in proportion of migraine days” shows promising results as well – also supported by the sensitivity analysis.
“I am very satisfied that PM010 thus far confirms the results from the pivotal randomized controlled trial PM007. The results are surprisingly clear, already at this early stage,” says Anders Weilandt, Chordate CEO, and continues:
“This is a long study with twelve-months follow up, and a lot more data needs to be accumulated – but it is very good to get this confirmation that the study is on track.”
