A Study of LY2951742 in Participants With Migraine

NCT ID: NCT01625988

Last Updated: 2020-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-28
• Study Completion Date: 2013-09-18

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)

Conditions

Migraine Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

LY2951742

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

LY2951742

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• 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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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

Clinical Research Advantage

Henderson, Nevada, United States

PharmQuest

Greensboro, North Carolina, United States

PMG Research of Winston-Salem

Winston-Salem, North Carolina, United States

COR Clinical Research, LLC

Oklahoma City, Oklahoma, United States

PMG Research of Bristol

Bristol, Tennessee, United States

ClinSearch

Chattanooga, Tennessee, United States

Nashville Neuroscience Group

Nashville, Tennessee, 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

FutureSearch Trials of Dallas

Dallas, Texas, United States

Clinical Trial Network (CTN Texas)

Houston, Texas, United States

Neurology & Headache Treatment Center

McLean, Virginia, United States

Countries

United States

References

Stauffer VL, Turner I, Kemmer P, Kielbasa W, Day K, Port M, Quinlan T, Camporeale A. Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials. J Headache Pain. 2020 Jun 23;21(1):79. doi: 10.1186/s10194-020-01148-9.

Reference Type: DERIVED

PMID: 32576229 (View on PubMed)

Goadsby PJ, Dodick DW, Martinez JM, Ferguson MB, Oakes TM, Zhang Q, Skljarevski V, Aurora SK. Onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine: a post-hoc analysis. J Neurol Neurosurg Psychiatry. 2019 Aug;90(8):939-944. doi: 10.1136/jnnp-2018-320242. Epub 2019 Apr 19.

Reference Type: DERIVED

PMID: 31004075 (View on PubMed)

Dodick DW, Goadsby PJ, Spierings EL, Scherer JC, Sweeney SP, Grayzel DS. Safety and efficacy of LY2951742, a monoclonal antibody to calcitonin gene-related peptide, for the prevention of migraine: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2014 Sep;13(9):885-92. doi: 10.1016/S1474-4422(14)70128-0. Epub 2014 Aug 10.

Reference Type: DERIVED

PMID: 25127173 (View on PubMed)

Other Identifiers

ART-01

Identifier Type: OTHER

Identifier Source: secondary_id

ART-01

Identifier Type: -

Identifier Source: org_study_id