New Caney

This research aims to evaluate the safety and effectiveness of IPN10200, a medication designed to prevent episodic and chronic migraine by stopping the release of chemical messengers that cause migraine pain. Adults aged 18 to 80 with a history of migraine for at least one year will participate to help determine the best dose and overall safety profile of IPN10200. The study is a Phase II, randomized, double-blind, placebo-controlled trial sponsored by Ipsen. The study includes three main periods: an initial screening to determine eligibility, followed by Step 1 which tests two doses of IPN10200 in separate cohorts to assess safety over 36 weeks, and Step 2 where new participants are grouped by migraine type and randomly assigned to receive either Dose A, Dose B, or placebo. Treatments are given as injections into muscles of the head, face, and neck in a single treatment cycle for each dose or placebo group. Participants will be asked to complete a daily electronic migraine diary and questionnaires throughout the study lasting up to 44 weeks. Researchers will monitor safety through adverse event reporting, laboratory tests, vital signs, facial examinations, ECG readings, and antibody levels. Efficacy will be assessed by changes in the number of monthly migraine and headache days. Safety and effectiveness data will be collected regularly until the final Week 36 visit.