Zaspy Wielkie

Researchers are evaluating the safety and effectiveness of IPN10200, a medication designed to prevent episodic and chronic migraines in adults aged 18 to 80. Migraines cause severe throbbing pain often accompanied by nausea and sensitivity to light and sound, caused by brain activation releasing pain-related chemicals. IPN10200 works by stopping the release of these chemical messengers, and this phase II study aims to find the right dose that balances safety and efficacy. The study has three periods: first, a screening to check eligibility; second, Step 1 where two different doses of IPN10200 are tested sequentially in two groups, with injections given into muscles of the head, face, and neck and safety monitored over 36 weeks; third, Step 2 where new participants with episodic or chronic migraine are randomly assigned to receive one of two doses or a placebo, also via injections in the same areas, with monitoring continuing until Week 36. Participants will complete a daily electronic migraine diary and questionnaires throughout the study lasting up to 44 weeks. Researchers will monitor safety by tracking adverse events, laboratory changes, vital signs, facial exams, ECG readings, and antibody development. They will also measure changes in monthly migraine days to evaluate treatment effectiveness while ensuring participant safety throughout the study.