Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP 301)

Inclusion Criteria:

• Documented diagnosis of migraine with or without aura, with at least 2 attacks permonth for the previous 6 months.
• Participants must be in good general health, with no significant medical history (excluding migraine).
• Participants must have the ability and willingness to attend the necessary visits atthe study center.
• Participants must be able to provide the written informed consent prior to entry intothe study.
• Women of childbearing potential must agree to use adequate contraception (as definedin the protocol and by study personnel) during the study and for 30 days after thelast dose fo the study drug.
• Male participants and their partners must agree to use effective contraception (asdefined in the protocol and by study personnel) during the study and for 30 days afterthe last dose of the study drug. Male participants should also refrain from spermdonation for 30 days after study completion.

Exclusion Criteria:

• Subjects with trigeminal autonomic cephalalgias (including cluster headache,hemicrania syndromes and short-lasting unilateral, neuralgiform headache attacks withconjunctival injection and tearing), hemiplegic migraine, or migraine with brainstemaura (previously referred to as basilar migraines).
• Subjects with chronic migraines, medication overuse headache or other chronic headachesyndromes.
• Subjects with ischemic heart disease or subjects with clinical symptoms or findingsconsistent with coronary artery vasospasm, including Prinzmetal's variant angina.
• Subjects with significant risk factors for coronary artery disease (CAD) includingcurrent use of nicotine-containing products, medical history of diabetes, uncontrolledhypertension (high blood pressure), known peripheral arterial disease, Raynaud'sphenomenon, sepsis or vascular surgery (within 3 months prior to study start), orseverely impaired hepatic or renal (kidney) function.
• Subjects with recurrent sinusitis or epistaxis.
• Subjects with a history or presence of alcoholism or drug abuse within 2 years priorto first study drug administration.
• Women who are pregnant, or planning to get pregnant, or who are lactating whileparticipating in the study.
• Use of any medications prohibited by protocol.
• Use of >12 days per month of triptan or ergot-based medication in the 2 months priorto screening. Other protocol-defined inclusion/exclusion criteria may apply.