Clinical trial NCT02163993: A Study of Galcanezumab (LY2951742) in Participants With Migraine Headache
Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients With Episodic Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine Headache
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-06-16
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase
timeFrame: Baseline, 12 Weeks
Secondary outcomes:
measure: Mean Change From Baseline in Number of Migraine Attacks in the Last 28-Day Period of the 12-Week Treatment Phase
timeFrame: Baseline, 12 Weeks
measure: Percentage of Participants With ≥50% Reduction in Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase
timeFrame: Week 12
measure: 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
timeFrame: Baseline, 12 Weeks
measure: Mean Change From Baseline in Number of Headache Hours in the Last 28-Day Period of the 12-Week Treatment Phase
timeFrame: Baseline, 12 Weeks
measure: Change From Baseline to 12 Week Endpoint in Migraine Specific Quality of Life (MSQL) Questionnaire Total Scores
timeFrame: Baseline, 12 Weeks
measure: Change From Baseline to 12 Week Endpoint in the Headache Impact Test-6™ (HIT-6™) Scores
timeFrame: Baseline, 12 Weeks
measure: Serum Concentration of Galcanezumab
timeFrame: 12 Weeks
measure: Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
timeFrame: 12 Weeks
measure: Percentage of Participants Developing Anti-drug Antibodies to Galcanezumab
timeFrame: Baseline through 12 Weeks
measure: Percentage of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Scores
timeFrame: Baseline through Week 12
measure: Mean Change From Baseline in the Number of Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase
timeFrame: Baseline, 12 Weeks
measure: Mean Change From Baseline in the Number of Moderate-Severe Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase
timeFrame: Baseline, 12 Weeks
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Clinical Research Advantage
state: Arizona
city: Phoenix
country: United States
facility: 21st Century Neurology
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Encino
country: United States
facility: Pharmacology Research Institute, Long Beach
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network - CNS
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute, Long Beach
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute, Long Beach
state: California
city: Rancho Mirage
country: United States
facility: Desert Valley Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: San Francisco
country: United States
facility: San Francisco Clinical Research Center
state: California
city: Santa Monica
country: United States
facility: California Medical Clinic for Headache
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Stamford
country: United States
facility: New England Institute for Clinical Research
state: Connecticut
city: DeLand
country: United States
facility: Avail Clinical Research LLC
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center LLC
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Psychiatric Inst of Florida-Clinical Neuroscience Solutions
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute at Palm Beach Neurology
state: Florida
city: Edgewood
country: United States
facility: Otri-Med Corporation
state: Kentucky
city: Baltimore
country: United States
facility: PharmaSite Research Inc
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials Inc
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head, Pain and Neurological Institute
state: Michigan
city: Kalamazoo
country: United States
facility: Westside Family Medical Center
state: Michigan
city: Saint Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Springfield
country: United States
facility: ClinVest
state: Missouri
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: Plainview
country: United States
facility: Island Neuro Associates,PC
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Portland
country: United States
facility: Summit Research Network Inc
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center, Inc.
state: South Carolina
city: Memphis
country: United States
facility: CNS Health Care
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Austin
country: United States
facility: DermResearch
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: North Seattle Womens Group
state: Washington
city: Middleton
country: United States
facility: Dean Foundation for Health Research and Education
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.