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A Study in Migraine Prevention

Primary Purpose

Migraine Headache

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Placebo

LY2300559

About this trial

This is an interventional prevention trial for Migraine Headache focused on measuring classic with aura, common without aura, migraine, headache

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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Have previously completed or withdrawn from this study or any other study investigating LY2300559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

Sites / 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LY2300559

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline to 12 Week Endpoint in Severity of Migraine Intensity (Mild, Moderate, Severe)

The participant-reported severity of migraines was rated on a 3-point categorical scale (Mild, Moderate, or Severe). Participants could report a severity of none (score = 0), mild (1), moderate (2), or severe (3). In general, if a headache was mild, daily activities could be resumed and little to no medication was taken. Moderate headaches required medication and effected daily activities. Severe headaches were debilitating and required medication. If a participant had multiple migraines during Month 3 (normalized to 28 days), the most severe migraine was analyzed.

Change From Baseline to 12 Week Endpoint in Average Duration of Migraine Symptoms

The duration of migraine symptoms was the amount of time from the beginning of each individual migraine attack to the end of each migraine attack. Two attacks separated by <24 hours were considered part of the same migraine and duration was calculated as such. Migraine symptoms included photophobia, phonophobia, nausea, and vomiting. No data collected for aura and vomiting's migraine symptoms.

Mean Change From Baseline to 12 Week Endpoint in the Number of Migraine Days

A migraine day was any day with a migraine attack (a headache lasting 4 to 72 hours). The number of migraine days per month was normalized to a 28-day month and calculated as the (number of migraine days*28)/number of days in the specified month.

Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Improvement (CGI-I)

The CGI-I was a 1-item scale that measured the clinician's perception of the improvement in migraine symptoms compared with the start of treatment. Scores ranged from 1 (very much improved) to 7 (very much worse). A score of 4 indicated no change.

Change From Baseline to 12 Week Endpoint in Patient's Global Impression of Improvement (PGI-I)

The PGI-I was a 1-item scale that measured the participant's perception of improvement in migraine symptoms compared with the start of treatment. Scores ranged from 1 (very much improved) to 7 (very much worse). A score of 4 indicated no change.

Change From Baseline to 12 Week Endpoint in Migraine-Specific Quality of Life Questionnaire (MSQ) Score

The MSQ was a 14-item self-administered scale that assessed the participant's perception of quality of life for 3 dimensions [role restriction or restrictive function (Items 1-7), role prevention or preventive function (Items 8-11), and emotional function (Items 12-14)]. Participants rated each item from 1 (none of the time) to 6 (all of the time). Since each item was presented as a negative statement, participant responses were recoded before item scores were calculated. Then, dimension scores were calculated as the sum of the recoded items for that specific dimension. Each dimension score was transformed into a score that ranged from 0 to 100. The transformation formula for the restrictive function = [(dimension score-7)*100]/35, for the preventive function = [(dimension score-4)*100]/20, and for the emotional function = [(dimension score-3)*100]/15. A lower score indicated a poorer quality of life associated with that domain.

Change From Baseline to 12 Week Endpoint in Migraine Interictal Burden Scale (MIBS-4) Overall Weighted Score

MIBS-4 was a 4-item self-administered scale that assessed the impact of headaches on the participant's life between headache attacks. Each item measured a specific domain (impairment in work or school, impairment in family and social life, difficulty making plans or commitments, or emotional/affective and cognitive distress). For each item and domain, scores were weighted as follows: Don't know (0), Never (0), Rarely (1), Some of the time (2), Much of the time (3), and All of the time (4). The overall weighted score was the sum of the domain scores and ranged from 0 to 16. Higher scores indicated a greater impact of headaches on the participant's life between headache attacks.

Pharmacokinetics: Area Under the Plasma Concentration-Time Curve at the Steady State (AUCtau,ss) of LY2300559

Percentage of Participants Using Breakthrough Medications

Participants were allowed to use a pre-approved list of medications for the treatment of breakthrough migraines during the study, as long as the treatments were the same as those used and reported during the baseline period. Any medications or procedures to prevent migraines were not allowed. Percentage of participants = (number of participants using breakthrough medication/total number of participants)*100. Each month was normalized to a 28-day month.

Full Information

NCT ID

NCT01184508

First Posted

August 17, 2010

Last Updated

August 14, 2018

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01184508

Brief Title

A Study in Migraine Prevention

Official Title

A Randomized, Double-Blind, Placebo Controlled Proof of Concept Study of LY2300559 in Patients With Migraine

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Terminated

Why Stopped

Elevation of ALT and AST in some patients.

Study Start Date

January 2011 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine Headache

Keywords

classic with aura, common without aura, migraine, headache

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

87 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LY2300559

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered orally, once daily, for 12 weeks

Intervention Type

Drug

Intervention Name(s)

LY2300559

Intervention Description

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

Primary Outcome Measure Information:

Title

Change From Baseline to 12 Week Endpoint in the Number of Migraine Attacks

Description

Time Frame

Baseline and Month 3

Secondary Outcome Measure Information:

Title

Change From Baseline to 12 Week Endpoint in Severity of Migraine Intensity (Mild, Moderate, Severe)

Description

Time Frame

Baseline and Month 3

Title

Change From Baseline to 12 Week Endpoint in Average Duration of Migraine Symptoms

Description

Time Frame

Baseline and Month 3

Title

Mean Change From Baseline to 12 Week Endpoint in the Number of Migraine Days

Description

Time Frame

Baseline and Month 3

Title

Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Improvement (CGI-I)

Description

Time Frame

Baseline(Day 28) and Week 12 (Day 84)

Title

Change From Baseline to 12 Week Endpoint in Patient's Global Impression of Improvement (PGI-I)

Description

Time Frame

Baseline (Day 28) and Week 12 (Day 84)

Title

Change From Baseline to 12 Week Endpoint in Migraine-Specific Quality of Life Questionnaire (MSQ) Score

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline to 12 Week Endpoint in Migraine Interictal Burden Scale (MIBS-4) Overall Weighted Score

Description

Time Frame

Baseline and Week 12

Title

Pharmacokinetics: Area Under the Plasma Concentration-Time Curve at the Steady State (AUCtau,ss) of LY2300559

Time Frame

Baseline and Week 8 (1 to 3 hours postdose), Weeks 2 and 4 (predose and 1 to 3 hours postdose), Week 12 (predose, 1 to 3 hours postdose, and 5 hours postdose)

Title

Percentage of Participants Using Breakthrough Medications

Description

Time Frame

Month 3

Other Pre-specified Outcome Measures:

Title

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

Description

Participants were allowed to use a pre-approved list of medications for the treatment of breakthrough migraines during the study, as long as the treatments were the same as those used and reported during the baseline period. Any medications or procedures to prevent migraines were not allowed. The mean number was calculated by the breakthrough (BH) medications (meds) per migraine used by each participant per month. Each month was normalized to a 28-day month.

Time Frame

Baseline, Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85004

Country

United States

Facility Name

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

City

Fairfield

State/Province

Connecticut

ZIP/Postal Code

06824

Country

United States

Facility Name

City

Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48104

Country

United States

Facility Name

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107 5098

Country

United States

Facility Name

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

City

San Juan

ZIP/Postal Code

00923

Country

Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

A Study in Migraine Prevention

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