FRANKFURT, Germany & RALEIGH, N.C.– Merz Therapeutics GmbH, a neurology-focused specialty pharmaceutical company, announced today that the first patients have been enrolled in two global Phase III clinical trials evaluating XEOMIN® (incobotulinumtoxinA) for the prevention of migraine in adults. The studies, known as MINT-E (NCT07018700) and MINT-C (NCT07018713), will assess XEOMIN’s safety and efficacy in patients with episodic and chronic migraine, conditions that together affect more than one billion people worldwide.
“Despite the availability of multiple treatment options, the need remains for additional options for prevention of migraines,” said Stefan König, Chief Executive Officer of Merz Therapeutics. “The enrollment of the first patients in the MINT trials marks an important milestone as we aim to address persistent gaps in migraine care by advancing a new neurotoxin option for patients.”
The MINT program will enroll about 1,770 adult patients across 120 study sites in North America and Europe. MINT-E will include roughly 990 participants with episodic migraine (fewer than 15 headache days per month, including six to 14 migraine days), while MINT-C will include about 780 participants with chronic migraine (15 or more headache days per month, including at least eight migraine days).
Both studies will measure the change in monthly migraine days from baseline to Month 6 as the primary endpoint. Secondary endpoints include changes in headache days, acute medication days, and migraine frequency over two-week periods at the end of each injection cycle. Patient enrollment is currently active in North America, with European recruitment expected to follow shortly.
“These trials were designed with the patient experience at the forefront — from trial design and eligibility criteria that reflect current migraine patterns to endpoints that capture the full impact of migraine on daily life,” said Stefan Albrecht, Chief Scientific and Medical Officer of Merz Therapeutics. “By ensuring representation across both episodic and chronic migraine, we aim to generate data that is not only clinically robust but also deeply relevant to the people we hope to serve.”
