A Study of Galcanezumab (LY2951742) in Participants With Migraine Headache

NCT02163993 | Completed Phase 2 Results DMC

• 2 other identifiers: 15414I5Q-MC-CGAB
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 40

Brief Summary

The main purpose of this study is to evaluate whether the study drug known as galcanezumab is safe and effective in the prevention of migraine headaches.

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 (ICHD)-3 beta. 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-3 beta 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.

  Baseline, 12 Weeks

Secondary Outcomes (12)

• Mean Change From Baseline in Number of Migraine Attacks in the Last 28-Day Period of the 12-Week Treatment Phase

  Baseline, 12 Weeks

• Percentage of Participants With ≥50% Reduction in Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase

  Week 12

• Mean Change From Baseline in the Number of Days of Medication Use for the Treatment of Migraine Headache in the Last 28-Day Period of the 12-Week Treatment Phase

  Baseline, 12 Weeks

• Mean Change From Baseline in Number of Headache Hours in the Last 28-Day Period of the 12-Week Treatment Phase

  Baseline, 12 Weeks

• Change From Baseline to 12 Week Endpoint in Migraine Specific Quality of Life (MSQL) Questionnaire Total Scores

  Baseline, 12 Weeks

Study Arms (5)

5mg Galcanezumab

EXPERIMENTAL

5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.

Drug: Galcanezumab

50mg Galcanezumab

EXPERIMENTAL

50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.

Drug: Galcanezumab

120mg Galcanezumab

EXPERIMENTAL

120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.

Drug: Galcanezumab

300mg Galcanezumab

EXPERIMENTAL

300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.

Drug: Galcanezumab

Placebo

PLACEBO COMPARATOR

Placebo given as SQ injections once every 28 days during a 12 week treatment period.

Drug: Placebo

Interventions

Galcanezumab DRUG

Administered SQ

Also known as: LY2951742

120mg Galcanezumab; 300mg Galcanezumab; 50mg Galcanezumab; 5mg Galcanezumab

Placebo DRUG

Administered SQ

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:

• Participants with a history of migraine of at least 1 year prior to enrollment.
• Migraine onset prior to age 50.

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.
• Current use or any prior exposure to any CGRP antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).
• History of migraine subtypes including hemiplegic migraine, ophthalmoplegic migraine, and basilar-type migraine.
• Have a history or presence of other medical illness that indicates a medical problem that would preclude study participation.
• Failure to respond to more than two adequately dosed effective migraine prevention treatments.
• Evidence of significant active psychiatric disease, in the opinion of the investigator.
• Women who are pregnant or nursing.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (40)

Clinical Research Advantage

Gilbert, Arizona, 85234, United States

Location

21st Century Neurology

Phoenix, Arizona, 85004, United States

Location

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Pharmacology Research Institute, Long Beach

Encino, California, 91316, United States

Location

Collaborative Neuroscience Network - CNS

Long Beach, California, 90806, United States

Location

Pharmacology Research Institute, Long Beach

Los Alamitos, California, 90720, United States

Location

Pharmacology Research Institute, Long Beach

Newport Beach, California, 92660, United States

Location

Desert Valley Research

Rancho Mirage, California, 92270, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92013, United States

Location

Medical Center for Clinical Research

San Diego, California, 92108, United States

Location

San Francisco Clinical Research Center

San Francisco, California, 94109, United States

Location

California Medical Clinic for Headache

Santa Monica, California, 90404, United States

Location

Alpine Clinical Research Center

Boulder, Colorado, 80304, United States

Location

New England Institute for Clinical Research

Stamford, Connecticut, 06905, United States

Location

Avail Clinical Research LLC

DeLand, Florida, 32720, United States

Location

Florida Clinical Research Center LLC

Maitland, Florida, 32751, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Psychiatric Inst of Florida-Clinical Neuroscience Solutions

Orlando, Florida, 32801, United States

Location

Premiere Research Institute at Palm Beach Neurology

West Palm Beach, Florida, 33407, United States

Location

Otri-Med Corporation

Edgewood, Kentucky, 41017, United States

Location

PharmaSite Research Inc

Baltimore, Maryland, 21208, United States

Location

Boston Clinical Trials Inc

Boston, Massachusetts, 02131, United States

Location

Michigan Head, Pain and Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

Westside Family Medical Center

Kalamazoo, Michigan, 49009, United States

Location

ClinVest

Springfield, Missouri, 68507, United States

Location

Mercy Health Research

St Louis, Missouri, 63141, United States

Location

Albuquerque Clinical Trials

Albuquerque, New Mexico, 87102, United States

Location

Island Neuro Associates,PC

Plainview, New York, 11803, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

PharmQuest

Greensboro, North Carolina, 27408, United States

Location

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Summit Research Network Inc

Portland, Oregon, 97210, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Coastal Carolina Research Center, Inc.

Mt. Pleasant, South Carolina, 29464, United States

Location

CNS Health Care

Memphis, Tennessee, 38119, United States

Location

FutureSearch Trials

Austin, Texas, 78731, United States

Location

DermResearch

Austin, Texas, 78759, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

North Seattle Womens Group

Seattle, Washington, 98105, United States

Location

Dean Foundation for Health Research and Education

Middleton, Wisconsin, 53562, United States

Location

Related Publications (4)

• 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

• Bangs ME, Kudrow D, Wang S, Oakes TM, Terwindt GM, Magis D, Yunes-Medina L, Stauffer VL. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies. BMC Neurol. 2020 Jan 17;20(1):25. doi: 10.1186/s12883-020-1609-7.

  PMID: 31952501 DERIVED

• Kielbasa W, Quinlan T. Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine. J Clin Pharmacol. 2020 Feb;60(2):229-239. doi: 10.1002/jcph.1511. Epub 2019 Sep 4.

  PMID: 31482569 DERIVED

• Skljarevski V, Oakes TM, Zhang Q, Ferguson MB, Martinez J, Camporeale A, Johnson KW, Shan Q, Carter J, Schacht A, Goadsby PJ, Dodick DW. Effect of Different Doses of Galcanezumab vs Placebo for Episodic Migraine Prevention: A Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):187-193. doi: 10.1001/jamaneurol.2017.3859.

  PMID: 29255900 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: GT60
• 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 12, 2014
• First Posted: June 16, 2014
• Study Start: July 7, 2014
• Primary Completion: August 19, 2015
• Study Completion: February 12, 2018
• Last Updated: November 23, 2018
• Results First Posted: November 23, 2018

Record last verified: 2017-06

Locations

US (40)