A Study of LY2951742 in Participants With Migraine

NCT01625988 | Completed Phase 2 Results

• 1 other identifier: ART-01
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 37

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.

Conditions

Migraine Headache

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-day Period of the 12-week Treatment Phase

  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.

  Baseline, 12 weeks

Secondary Outcomes (3)

• 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

• 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

• Percentage of Responders

  Baseline, 4, 8, and 12 weeks

Study Arms (2)

LY2951742

EXPERIMENTAL

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.

Drug: LY2951742

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

LY2951742 DRUG

LY2951742

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (37)

Neurological Physicians of Arizona / Clinical Research Advantage

Gilbert, Arizona, 85234, United States

Location

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Mayo Foundation for Medical Education and Research - Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

PRI Encino

Encino, California, 91316, United States

Location

Allergy and Asthma Specialists Medical Group

Huntington Beach, California, 92647, United States

Location

Collaborative Neuroscience Network Inc.

Long Beach, California, 90806, United States

Location

PRI Los Alamitos

Los Alamitos, California, 90720, United States

Location

PRI Newport Beach

Newport Beach, California, 92660, United States

Location

Medical Center for Clinical Research

San Diego, California, 92108, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92123, United States

Location

San Francisco Clinical Research Center

San Francisco, California, 94109, United States

Location

University of California, San Francisco (UCSF) Medical Center - Headache Center

San Francisco, California, 94115, United States

Location

California Medical Clinic for Headache Inc

Santa Monica, California, 90404, United States

Location

Radiant Research - Denver

Denver, Colorado, 80239, United States

Location

Florida Clinical Research Center LLC

Maitland, Florida, 32751, United States

Location

Accelovance, Inc

Melbourne, Florida, 32935, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Broward Research Group

Pembroke Pines, Florida, 33026, United States

Location

Neurology Clinical Research Inc

Sunrise, Florida, 33351, United States

Location

MedVadis Research

Watertown, Massachusetts, 02472, United States

Location

Westside Family Medical Center, PC

Kalamazoo, Michigan, 49009, United States

Location

Ryan Headache Center, St. John's Mercy Medical Group

Chesterfield, Missouri, 63141, United States

Location

Clinvest, A Division of Banyan Group, Inc.

Springfield, Missouri, 65807, United States

Location

Prarie Fields Medicine/Clinical Research Advantage

Fremont, Nebraska, 68025, United States

Location

James Meli DO Ltd (Clinical Research Advantage)

Henderson, Nevada, 89014, United States

Location

Clinical Research Advantage

Henderson, Nevada, 89052, United States

Location

PharmQuest

Greensboro, North Carolina, 27408, United States

Location

PMG Research of Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

COR Clinical Research, LLC

Oklahoma City, Oklahoma, 73103, United States

Location

PMG Research of Bristol

Bristol, Tennessee, 37620, United States

Location

ClinSearch

Chattanooga, Tennessee, 37421, United States

Location

Nashville Neuroscience Group

Nashville, Tennessee, 37203, United States

Location

FutureSearch Trials of Neurology and Sleep Lab

Austin, Texas, 78731, United States

Location

Neurology Studies of Austin, A Division of DermResearch Inc.

Austin, Texas, 78759, United States

Location

FutureSearch Trials of Dallas

Dallas, Texas, 75231, United States

Location

Clinical Trial Network (CTN Texas)

Houston, Texas, 77074, United States

Location

Neurology & Headache Treatment Center

McLean, Virginia, 22102, United States

Location

Related Publications (3)

• 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.

  PMID: 32576229 DERIVED

• 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.

  PMID: 31004075 DERIVED

• 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.

  PMID: 25127173 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

galcanezumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: June 22, 2012
• Study Start: June 28, 2012
• Primary Completion: July 1, 2013
• Study Completion: September 18, 2013
• Last Updated: January 9, 2020
• Results First Posted: January 9, 2020

Record last verified: 2014-04

Locations

US (37)