A Study of LY2951742 in Participants With Migraine
- Registration Number
- NCT01625988
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
To assess the efficacy and safety of LY2951742 in the prevention of migraine headache in migraineurs with or without aura during 3 months of treatment.
- Detailed Description
The study is comprised of 4 trial periods:
1. Screening and washout (5-45 days)
2. Baseline for assessment of the type, frequency, and severity of headaches (28-38 days)
3. Treatment (12 weeks)
4. Follow-up (12 weeks)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 218
- Have a history of migraine as defined by the International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004) of at least 1 year prior to enrollment, migraine onset prior to age 50, and a moderate frequency of migraine headaches
- Women of child-bearing potential (not surgically sterile or at least 1 year post-menopause) must test negative for pregnancy at the time of screening based on a serum pregnancy test and must agree to use a reliable method of birth control during the study and for 3 months following completion of participation in the study
- Have clinical laboratory test results within normal reference ranges or, if outside the normal range, judged not clinically significant by the Investigator
- Must not be on any migraine prevention therapy, including botulinum toxin (Botox)
- Agree not to post any personal medical data related to the study or information related to the study on any website or social media site (for example, Facebook, Twitter, et cetera) until the trial has completed
- Current enrollment in, or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device, or concurrent enrollment in any other type of medical research judged not to be scientifically or medically compatible with this study
- Previous completion or withdrawal from this study or any other study investigating LY2951742 or other therapeutic antibodies that target calcitonin gene-related peptide (CGRP)
- History of chronic migraine or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and basilar-type migraine
- History of headache (for example, cluster headache or Medication Overuse Headache [MOH]) other than migraine or tension type headache as defined by IHS ICHD-II within 12 months prior to randomization
- Evidence of significant active psychiatric disease including, but not limited to, manic depressive illness, schizophrenia, generalized anxiety disorder, obsessive compulsive disorder, personality disorders, or other serious mood, anxiety, depression, or substance use disorders
- Have a history or presence of any other medical illness that in the judgment of the Investigator, indicates a medical problem that would preclude study participation
- Women who are pregnant or nursing
- Confirmed corrected QT (QTc) interval >470 milliseconds (msec) for women and >450 for men
- Excessive alcohol, opiate, or barbiturate use; history of drug abuse or dependence
- In the opinion of the Investigator, have no other issues that would interfere with compliance with the study requirements and completion of evaluations required for this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY2951742 LY2951742 LY2951742: 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period. Placebo Placebo Placebo: 0.9% Sodium Chloride, Untied States Pharmacopoeia (USP), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-day Period of the 12-week Treatment Phase Baseline, 12 weeks The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least square (LS) means were calculated using mixed model repeated measures (MMRM) with baseline value, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in the Number of Headache Days in the Last 28-day Period of the 12-week Treatment Phase Baseline, 12 weeks Number of calendar days on which a headache lasts ≥4 hours which includes migraines, probable migraines (PM) and nonmigraines. Criteria for migraine headache (MH) was adapted from standard IHS ICHD-II guidelines 1.1 and 1.2 (Cephalgia 2004). Definition of MH was headache with or without aura, of ≥30 min duration, and with both ("A" and "B") required features from IHS ICHD-II definition. Required feature "A" includes ≥2 of following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of following during headache: nausea and/or vomiting, or photophobia and phonophobia. PM is headache with or without aura, but missing 1 feature needed to fulfill all criteria for MH. LS means were calculated using MMRM with baseline value, gender, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect.
Mean Change From Baseline in the Number of Migraine Attacks in the Last 28-day Period of the 12-week Treatment Phase Baseline, 12 weeks A migraine attack was defined as beginning on any day a migraine headache day was recorded and ending when a migraine headache-free day occurred. The criteria for a migraine headache was adapted from the standard IHS ICHD-II guidelines 1.1 and 1.2 (Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. LS means were calculated using MMRM with baseline value, gender, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect.
Percentage of Responders Baseline, 4, 8, and 12 weeks Percentage of participants with greater than 50% reduction in the number of migraine headache days in a 28-day period. The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia.
Trial Locations
- Locations (37)
Neurological Physicians of Arizona / Clinical Research Advantage
🇺🇸Gilbert, Arizona, United States
Ryan Headache Center, St. John's Mercy Medical Group
🇺🇸Chesterfield, Missouri, United States
PharmQuest
🇺🇸Greensboro, North Carolina, United States
University of California, San Francisco (UCSF) Medical Center - Headache Center
🇺🇸San Francisco, California, United States
Nashville Neuroscience Group
🇺🇸Nashville, Tennessee, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Allergy and Asthma Specialists Medical Group
🇺🇸Huntington Beach, California, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Accelovance, Inc
🇺🇸Melbourne, Florida, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Broward Research Group
🇺🇸Pembroke Pines, Florida, United States
San Francisco Clinical Research Center
🇺🇸San Francisco, California, United States
California Medical Clinic for Headache Inc
🇺🇸Santa Monica, California, United States
Florida Clinical Research Center LLC
🇺🇸Maitland, Florida, United States
Neurology Clinical Research Inc
🇺🇸Sunrise, Florida, United States
MedVadis Research
🇺🇸Watertown, Massachusetts, United States
FutureSearch Trials of Dallas
🇺🇸Dallas, Texas, United States
James Meli DO Ltd (Clinical Research Advantage)
🇺🇸Henderson, Nevada, United States
ClinSearch
🇺🇸Chattanooga, Tennessee, United States
Prarie Fields Medicine/Clinical Research Advantage
🇺🇸Fremont, Nebraska, United States
PMG Research of Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
PMG Research of Bristol
🇺🇸Bristol, Tennessee, United States
COR Clinical Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
FutureSearch Trials of Neurology and Sleep Lab
🇺🇸Austin, Texas, United States
Neurology Studies of Austin, A Division of DermResearch Inc.
🇺🇸Austin, Texas, United States
Clinical Trial Network (CTN Texas)
🇺🇸Houston, Texas, United States
Neurology & Headache Treatment Center
🇺🇸McLean, Virginia, United States
Radiant Research - Denver
🇺🇸Denver, Colorado, United States
Mayo Foundation for Medical Education and Research - Mayo Clinic
🇺🇸Scottsdale, Arizona, United States
PRI Encino
🇺🇸Encino, California, United States
Collaborative Neuroscience Network Inc.
🇺🇸Long Beach, California, United States
PRI Newport Beach
🇺🇸Newport Beach, California, United States
PRI Los Alamitos
🇺🇸Los Alamitos, California, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Westside Family Medical Center, PC
🇺🇸Kalamazoo, Michigan, United States
Clinvest, A Division of Banyan Group, Inc.
🇺🇸Springfield, Missouri, United States
Clinical Research Advantage
🇺🇸Henderson, Nevada, United States