Overview

A Study in Migraine Prevention

Status:
Terminated
Trial end date:
2012-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
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- Have previously completed or withdrawn from this study or any other study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