Merz Therapeutics has concluded patient enrolment in MINT-C and MINT-E, two global Phase III clinical trials assessing Xeomin (incobotulinumtoxinA) for adult migraine prevention.
The studies enrolled around 1800 participants to test the therapy's safety and efficacy in preventing both chronic and episodic migraine.
Patient intake reached completion six months ahead of schedule across 109 investigation sites located in Europe and North America.
In both trials, researchers are assessing the change in monthly migraine days from baseline to month six as the primary outcome.
Secondary endpoints evaluate differences in monthly headache days, acute medication days, and migraine frequency across two-week periods at the conclusion of each injection cycle.
The main study period is expected to finish during the coming year.
Merz Therapeutics chief scientific and medical officer Dr Stefan Albrecht said: “Achieving patient recruitment for both MINT-C and MINT-E six months ahead of plan is an important milestone for our Xeomin migraine prevention program. I am proud of what our teams, investigators and patients have achieved together.
“With recruitment now complete, our focus is on the main study period and subsequent analysis of the data. These results will guide our next clinical and regulatory decisions as we evaluate Xeomin for the preventive treatment of chronic and episodic migraine.”
Migraine involves recurrent attacks of moderate to severe head pain, frequently accompanied by nausea, vomiting, and sensitivity to light and sound.
Regulatory authorities have not approved Xeomin for preventing episodic or chronic migraine in adult patients.
Injected into muscles or glands, the prescription medication currently holds regulatory approvals in over 80 countries, such as Canada and the US.
These approvals cover aesthetic and neurological indications including cervical dystonia, spasticity, blepharospasm, hemifacial spasm, sialorrhoea, and upper facial lines in adults, as well as paediatric sialorrhoea and spasticity.
Headquartered in Frankfurt am Main, Germany, Merz Therapeutics operates in more than 80 countries as part of the Merz Group.
The company develops treatments targeting liver disease, movement disorders, and neurodegenerative conditions.
