As reported on PharmaTimes, Merz Therapeutics has announced the completion of participant enrollment in two international Phase 3 clinical trials investigating XEOMIN (incobotulinumtoxinA) as a potential preventive treatment for both episodic and chronic migraine.
The company reached its recruitment target approximately six months earlier than anticipated, enrolling nearly 1,800 adult participants across 109 research centers throughout North America and Europe. The milestone advances the development program for a condition that affects an estimated 1.1 billion people globally and continues to place a substantial burden on patients, healthcare providers, and healthcare systems.
The studies, known as MINT-E and MINT-C, are designed to evaluate the effectiveness of XEOMIN in reducing the number of monthly migraine days over a six-month treatment period. Researchers will compare migraine frequency at baseline with outcomes measured at Month 6.
In addition to the primary endpoint, investigators will examine several secondary measures, including changes in monthly headache days, use of acute migraine medications, and migraine occurrence during specified two-week periods following treatment cycles. The trials are intended to determine whether XEOMIN could serve as a viable preventive therapy for adults living with either episodic or chronic migraine.
Commenting on the achievement, Dr. Stefan Albrecht described the accelerated recruitment timeline as a significant step forward for the clinical development program. He credited the collaboration of study teams, investigators, and participants for helping the company surpass its enrollment goals ahead of schedule.
With recruitment now finalized, the focus shifts to patient follow-up, data collection, and analysis. According to Merz, the findings from the Phase 3 program will play a key role in shaping future regulatory and clinical strategies for XEOMIN as a potential migraine prevention treatment.
