A Study in Migraine Prevention

NCT ID: NCT01184508

Last Updated: 2018-09-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-04-30

Brief 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.

Conditions

Migraine Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

LY2300559

Group Type: EXPERIMENTAL

LY2300559

Intervention Type: DRUG

300 milligrams (mg) administered orally, once daily, for 12 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally, once daily, for 12 weeks

Interventions

Placebo

Administered orally, once daily, for 12 weeks

Intervention Type: DRUG

LY2300559

300 milligrams (mg) administered orally, once daily, for 12 weeks

Intervention Type: DRUG

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• Have previously completed or withdrawn from this study or any other study investigating LY2300559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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Phoenix, Arizona, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Long Beach, California, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Fairfield, Connecticut, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Miami, Florida, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

West Palm Beach, Florida, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Ann Arbor, Michigan, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

St Louis, Missouri, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Portland, Oregon, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Philadelphia, Pennsylvania, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Nashville, Tennessee, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Seattle, Washington, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

Other Identifiers

I1N-MC-CDBE

Identifier Type: OTHER

Identifier Source: secondary_id

13313

Identifier Type: -

Identifier Source: org_study_id