A Randomized, Double-blind, Placebo-controlled, Crossover, Multi-center Clinical Trial for the Evaluation of Efficacy, Safety, and Tolerability of ASY202 for the Acute Treatment of Migraine in Adult Patients
This study is testing an investigational inhaled migraine medication to see how well it works, how safe it is, and how well people tolerate it. Adults with migraine will receive both the study medication (ASY202) and a placebo (inactive treatment) at different times during the study. Neither participants nor study staff will know which treatment is given at the time. The medication is taken using a handheld dry powder inhaler to treat migraine attacks when they occur. Following screening, eligible participants will be enrolled and randomized to one of two treatments sequences i.e. one treatment sequence will receive ASY202 in treatment period 1 followed by placebo in treatment period 2 and other treatment sequence will receive placebo in treatment period 1 followed by ASY202 in treatment period 2. The study lasts about 16 weeks and includes a screening period, two treatment periods (with a minimum of 7 days washout period between the treatment periods), and a safety follow-up visit.
• Able to understand study procedures and provide written informed consent
• Male or female, 18-65 years of age at Screening
• BMI between 18.5-35 kg/m² at Screening
• Documented history of migraine (with or without aura) for ≥1 year, consistent with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)
• Female participants must be either:
‣ of non-childbearing potential, or
⁃ of childbearing potential using protocol required contraception