Merz Therapeutics has completed patient recruitment in two global Phase III clinical trials investigating XEOMIN (incobotulinumtoxinA) for the prevention of episodic and chronic migraine in adults, reaching the milestone six months ahead of schedule.
The MINT-E and MINT-C trials enrolled approximately 1,800 adults across 109 study sites in North America and Europe. The studies are designed to assess the efficacy and safety of XEOMIN as a potential preventive treatment for both forms of migraine.
“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,” said Stefan Albrecht, Chief Scientific and Medical Officer, Merz Therapeutics.
With recruitment complete, the trials will move further into the main study period, followed by data analysis. The findings are expected to inform the company's subsequent clinical and regulatory decisions.
“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,” Albrecht said.
The main study period is expected to conclude in 2027.
Both Phase III studies are evaluating the change in monthly migraine days from baseline to Month 6 as their primary endpoint.
Secondary endpoints include changes in monthly headache days, the number of days patients use acute medication, and migraine frequency during two-week periods at the end of each injection cycle.
The trials address a substantial global health challenge. Migraine affects approximately 1.1 billion people worldwide and places a significant burden on patients, healthcare systems and society.
Migraine is a neurological condition characterized by recurring attacks of moderate to severe head pain, often accompanied by nausea, vomiting and sensitivity to light and sound. Attacks can last between four and 72 hours, while some patients experience aura, including visual or sensory disturbances before an attack.
