Study Evaluating the Efficacy, Safety, and Tolerability of ASY202 (Dihydroergotamine Mesylate [DHE] Inhalation Powder Delivered Via a Multidose Dry Powder Inhaler) for the Acute Treatment of Migraine in Adult Patients
Start Date
5/19/2026
Completion Date
12/1/2026
Summary
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.
Eligibility Criteria
Age Range: 18 years to 65 years
Interventions
ASY202
Placebo
Conditions
Locations
Sunwise Clinical Research, Llc
Walnut Creek, California 94596
United States
Clinical Neuroscineces Solutions - Orlando
Orlando, Florida 32801
United States
Clinical Neuroscineces Solutions
Orlando, Florida 32806
United States
M3 Wake Research - Las Vegas Rainbow
Las Vegas, Nevada 89118
United States
Clinical Research Associates, Inc.
Nashville, Tennessee 37203
United States
Highland Research
Salt Lake City, Utah 84124
United States