Study to Determine the Efficacy and Safety of ELS-M11 in Acute Migraine

Inclusion Criteria: * Provide written informed consent * Males and females aged 18-65 who can read, write and understand English * Subject has at least a one year documented history of migraine headache (defined by International headache Society IHS) migraine definitions, with or without aura, with 2≤8 moderate or severe migraine attacks per month in the 2 months prior to the screening visit * Is stable on the current standard non-opioid rescue medication for at least 2 months prior to randomization * Can distinguish migraine from tension headache (HA), with 24 hours of freedom from HA between migraine events * Women of childbearing potential must be currently using or willing to use contraception (30 days prior to start of study medication and for 21 days after taking study medication) * Women of non-childbearing potential include females regardless of age, with functioning ovaries and who have a current documented tubal ligation \[Hatcher, 2004\] bilateral oophorectomy or total hysterectomy, or post-menopausal females * The subject is able and willing to perform the assessments and procedures as specified in this protocol, including the ability to learn and follow instructions for ePRO device Exclusion Criteria: * Migraineurs taking opioid-based rescue medications for any indication * Subject has history of mild migraine events or migraines that usually resolve spontaneously in less than 2 hours * Subject has menstrual migraines * Positive Drug Test * Subject has basilar…