Study in Participants With Acute Migraines Headaches
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Intervention: LY2590443; Placebo injection; Sumatriptan; Placebo capsule
Intervention description: 200 milligrams (mg) as four 50-mg capsules, oral, once; saline solution, injection, once; 6 milligrams (mg) injection (0.5 milliliter [mL] of 12 mg/mL solution), once; 4 capsules, once
Intervention MeSH terms: Sumatriptan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Migraine; Headache

Summary:

      This is a Phase 2, multicenter, randomized, double-blind, placebo and active
      comparator-controlled study of LY2590443 in approximately 200 participants with migraines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants between the ages of 18 and 65 years, inclusive.

          -  Participants who have migraine headaches, with or without aura (diagnosis according
             the International Classification of Headache Disorders-II), for at least 1 year.

          -  Participants who have had 2-8 migraine attacks on average per month for the last 3
             months (but less than 15 headache days per month).

          -  Participants who are willing and able to comply with the study schedule and
             requirements.

          -  Participants who speak, read, and understand English sufficiently well and are willing
             to provide written informed consent.

          -  Participants who in the opinion of the principal investigator are in good general
             health.

          -  Venous access should be sufficient to allow blood sampling as per protocol.

        Exclusion Criteria:

          -  Participants who do not or may not tolerate 5HT1 agonist treatments, with known
             hypersensitivity to sumatriptan (as discussed with the investigator).

          -  Female participants who have a positive pregnancy test at screening or pre- dose
             evaluation, or are breastfeeding.

          -  History or presence of significant medical illnesses as determined by the
             investigator.

          -  Participants with a current clinical diagnosis of major psychiatric disease.

          -  Regular use of known drugs of abuse; use of opiates for migraine rescue (no more than
             two times per month) is permissible.

          -  Blood donation of 500 milliliter (mL) or greater of whole blood products within 4
             weeks of study commencement, during the study, or 4 weeks following the study.

          -  Investigator site personnel directly affiliated with this study and their immediate
             families. Immediate family is defined as a spouse, parent, child, or sibling, whether
             biological or legally adopted.

          -  Consumption of more than three units of alcohol per day where one unit is defined as a
             12 ounces (oz) beer, 4 oz wine, or 2 oz of alcohol spirit liquor.

          -  Are unwilling or unable to comply with the use of a diary to directly record data from
             the participant.