A Study of LY2951742 in Participants With Migraine

Completed · Phase 2 · Has a placebo group

Conditions studied: Migraine Headache

In brief

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.

Key facts

Study ID

NCT01625988

Run by

Eli Lilly and Company

People needed

218

Starts

2012-06-28

Expected to finish

2013-09-18

Last updated by the study team

2020-01-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Neurological Physicians of Arizona / Clinical Research Advantage — Gilbert, Arizona, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Mayo Foundation for Medical Education and Research - Mayo Clinic — Scottsdale, Arizona, United States
• PRI Encino — Encino, California, United States
• Allergy and Asthma Specialists Medical Group — Huntington Beach, California, United States
• Collaborative Neuroscience Network Inc. — Long Beach, California, United States
• PRI Los Alamitos — Los Alamitos, California, United States
• PRI Newport Beach — Newport Beach, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• San Francisco Clinical Research Center — San Francisco, California, United States
• University of California, San Francisco (UCSF) Medical Center - Headache Center — San Francisco, California, United States
• California Medical Clinic for Headache Inc — Santa Monica, California, United States
• Radiant Research - Denver — Denver, Colorado, United States
• Florida Clinical Research Center LLC — Maitland, Florida, United States
• Accelovance, Inc — Melbourne, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Broward Research Group — Pembroke Pines, Florida, United States
• Neurology Clinical Research Inc — Sunrise, Florida, United States
• MedVadis Research — Watertown, Massachusetts, United States
• Westside Family Medical Center, PC — Kalamazoo, Michigan, United States
• Ryan Headache Center, St. John's Mercy Medical Group — Chesterfield, Missouri, United States
• Clinvest, A Division of Banyan Group, Inc. — Springfield, Missouri, United States
• Prarie Fields Medicine/Clinical Research Advantage — Fremont, Nebraska, United States
• James Meli DO Ltd (Clinical Research Advantage) — Henderson, Nevada, United States

Full record on ClinicalTrials.gov

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