Clinical trial NCT01184508 (phase 2, status: terminated)
Conditions: migraine headache
ICD codes: G43.B1, G43.D1, G43.B0, G43.D0, G43.A1, G43.411, G43.419
Drugs: placebo, ly2300559
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CCCC1=C(OCC2=CC=C(C=C2)[C@H](O)C2=CC=CC(=C2)C(O)=O)C=CC(C(C)=O)=C1O
Reason stopped: 
    elevation of alt and ast in some patients.
  
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          -  Have previously completed or withdrawn from this study or any other study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