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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Jan 2011

Shorter than P25 for phase_2

Geographic Reach

2 countries

12 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

First Submitted

Initial submission to the registry

August 17, 2010

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed

5 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed

6.5 years until next milestone

Results Posted

Study results publicly available

September 12, 2018

Completed

Last Updated

September 12, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

August 17, 2010

Results QC Date

February 17, 2018

Last Update Submit

August 14, 2018

Conditions

Migraine Headache

Keywords

classic with auracommon without auramigraineheadache

Outcome Measures

Primary Outcomes (1)

Change From Baseline to 12 Week Endpoint in the Number of Migraine Attacks
The definition of a migraine (a headache lasting 4 to 72 hours) was based on the International Headache Society (IHS) diagnostic criteria. The number of migraine attacks per month was normalized to a 28-day month and calculated as the (number of migraine attacks\*28 days)/number of days in the specified month.
Baseline and Month 3

Secondary Outcomes (9)

Change From Baseline to 12 Week Endpoint in Severity of Migraine Intensity (Mild, Moderate, Severe)
Baseline and Month 3
Change From Baseline to 12 Week Endpoint in Average Duration of Migraine Symptoms
Baseline and Month 3
Mean Change From Baseline to 12 Week Endpoint in the Number of Migraine Days
Baseline and Month 3
Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Improvement (CGI-I)
Baseline(Day 28) and Week 12 (Day 84)
Change From Baseline to 12 Week Endpoint in Patient's Global Impression of Improvement (PGI-I)
Baseline (Day 28) and Week 12 (Day 84)
+4 more secondary outcomes

Other Outcomes (1)

Change From Baseline to 12 Week Endpoint in Breakthrough Treatment Therapy for Acute Migraine Attacks
Baseline, Week 12

Study Arms (2)

LY2300559

EXPERIMENTAL

Drug: LY2300559

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PlaceboDRUG

Administered orally, once daily, for 12 weeks

Placebo

LY2300559DRUG

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

LY2300559

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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
+3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (12)

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, 85004, United States

Location

Long Beach, California, 90806, United States

Location

Fairfield, Connecticut, 06824, United States

Location

Miami, Florida, 33143, United States

Location

West Palm Beach, Florida, 33407, United States

Location

Ann Arbor, Michigan, 48104, United States

Location

St Louis, Missouri, 63141, United States

Location

Portland, Oregon, 97210, United States

Location

Philadelphia, Pennsylvania, 19107 5098, United States

Location

Nashville, Tennessee, 37203, United States

Location

Seattle, Washington, 98104, United States

Location

San Juan, 00923, Puerto Rico

Location

MeSH Terms

Conditions

Migraine DisordersHeadache

Interventions

LY2300559

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was stopped due to clinically significant elevations of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in some participants. Due to early study termination, the planned sample size was not met.

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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)
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 19, 2010

Study Start

January 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

September 12, 2018

Results First Posted

September 12, 2018

Record last verified: 2018-08

Locations

PR(1)US(11)

Study Stopped

A Study in Migraine Prevention

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Other Outcomes (1)

Study Arms (2)

LY2300559

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (12)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Other Outcomes (1)

Study Arms (2)

LY2300559

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (12)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations