Randomized, sham-controlled, double-blind study for acute migraine attacks.~Treatment Phase:~• ≤60 days to present at clinic for treating up to 2 migraines (at least 48 hours apart). First treatment is randomized between active treatment and sham treatment. Second optional treatment is open-label.~Post-Treatment Follow-up Phase:~24 hours after initiating treatment, for each of up to two migraine treatments, for conducting post-treatment follow-up assessments of migraine symptoms.~30, 60, and 90 days following the first migraine treatment for migraine diary assessments (and MIDAS assessment at 90 days)~Collection of migraine diaries at 30, 60, & 90 days post enrollment. Collection of MIDAS data at 60 and 90 days post treatment.
Randomized, sham-controlled, double-blind study for acute migraine attacks. Randomized to active treatment and sham treatment arms for the first treatment. Optional second active treatment. Follow up at 0, 2 and 24 hours post-treatment.