A Study in Migraine Prevention
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Intervention: Placebo; LY2300559
Intervention description: Administered orally, once daily, for 12 weeks; 300 milligrams (mg) administered orally, once daily, for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: classic with aura; common without aura; migraine; headache

Summary:

      The primary objective of this study is to measure the change in frequency of migraine attacks
      per 28 days in migraine patients being treated orally with LY2300559 for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are migraine patients with migraine onset before 50 years of age

          -  Present with diagnosis of at least 1 year with migraine attack defined by
             International Headache Society (IHS) guidelines

          -  Have a frequency of 4 to 14 migraine attacks, with or without aura, per month (with no
             more than 14 headache days per month, migraine or non-migraine) for at least the last
             6 months

          -  Female patients of childbearing potential must test negative for pregnancy at the time
             of enrollment and agree to use a reliable method of birth control during the study

        Exclusion Criteria:

          -  Are currently enrolled in, or discontinued within the previous 6 months from a
             migraine clinical trial involving an investigational drug or device or off-label use
             of a drug or device

          -  Are currently enrolled in, or discontinued within the previous 30 days from screening
             from a non-migraine clinical trial involving an investigational drug or device or
             off-label use of a drug or device, or concurrently enrolled in any other type of
             medical research judged not to be scientifically or medically compatible with this
             study

          -  Have previously completed or withdrawn from this study or any other study
             investigating LY2300559

          -  Have known allergies to LY2300559 or related compounds (such as montelukast)

          -  Are under treatment with medication or procedures for prevention of migraine, or are
             taking any other medications that are excluded by the protocol

          -  Have a history of alcohol or drug abuse/dependence within the past 3 months of
             screening or are currently using alcohol, drugs of abuse (including opioids,
             barbiturates, and marijuana), or any prescribed or over-the-counter medication in a
             manner that the investigator considers indicative of abuse/dependence

          -  Screen positive for drugs of abuse

          -  Patients with medication overuse headache as per IHS definition

          -  Have a body mass index (BMI) of less than 18.5 or greater than or equal to 35.0

          -  Have history or presence of cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, hematological or neurological disorders capable of
             significantly altering the absorption, metabolism, or elimination of drugs,
             constituting a risk when taking the study medication or interfering with the
             interpretation of the data

          -  Show evidence of serious active neuropsychiatric disease including, but not limited
             to, bipolar disorder, schizophrenia, psychosis, cluster B personality disorders [for
             example (eg), borderline personality disorder or narcissistic personality disorder],
             obsessive-compulsive disorder, or other serious mood, anxiety, depression, or
             substance/alcohol use disorders

          -  Have ever in his/her lifetime attempted suicide, have any recent suicidal ideation
             within the last 3 months, or are at significant risk to commit suicide, as judged by
             the investigator

          -  Show evidence or have history of neurological disease such as cerebral vascular
             accident, pseudotumor cerebri, multiple sclerosis, transient ischemic attack, syncopal
             episodes, encephalitis, or meningitis

          -  Have a history or seizures other than febrile

          -  Female patients who are pregnant or breast-feeding

          -  Females of childbearing potential who are not using a clinically acceptable method of
             birth control (eg, oral contraceptives or abstinence)

          -  Are unwilling or unable to comply with the use of a data collection device to directly
             record patient data

          -  Are otherwise unable to comply with the requirements of the study