Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP 301)
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Intervention: INP104
Intervention description: No more than 2 doses within 24 hours, 3 doses within 7 days. 1.45 mg in a divided dose, one actuation per nostril.
Intervention MeSH terms: Dihydroergotamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 360.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study consists of a 4-week screening period, a 24-week treatment period for all
      participants, followed by a 28-week treatment period extension (to 52 weeks in total) for a
      subset of at least 60 and up to 80 participants, and a 2-week post-treatment follow-up
      period.
    

Eligibility criteria:

        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.