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 per
month 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 at
the study center.

- Participants must be able to provide the written informed consent prior to entry into
the study.

- Women of childbearing potential must agree to use adequate contraception (as defined
in the protocol and by study personnel) during the study and for 30 days after the
last dose fo the study drug.

- Male participants and their partners must agree to use effective contraception (as
defined in the protocol and by study personnel) during the study and for 30 days after
the last dose of the study drug. Male participants should also refrain from sperm
donation 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 with
conjunctival injection and tearing), hemiplegic migraine, or migraine with brainstem
aura (previously referred to as basilar migraines).

- Subjects with chronic migraines, medication overuse headache or other chronic headache
syndromes.

- Subjects with ischemic heart disease or subjects with clinical symptoms or findings
consistent with coronary artery vasospasm, including Prinzmetal's variant angina.

- Subjects with significant risk factors for coronary artery disease (CAD) including
current use of nicotine-containing products, medical history of diabetes, uncontrolled
hypertension (high blood pressure), known peripheral arterial disease, Raynaud's
phenomenon, sepsis or vascular surgery (within 3 months prior to study start), or
severely 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 prior
to first study drug administration.

- Women who are pregnant, or planning to get pregnant, or who are lactating while
participating 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 prior
to screening.

Other protocol-defined inclusion/exclusion criteria may apply.