Evaluation of Galcanezumab in the Prevention of Chronic Migraine
- Registration Number
- NCT02614261
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic migraine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1117
Main Study:
- Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.
Israel addendum:
- Participants must have completed all phases of main study, including the 4-month post-treatment follow-up phase, during which no investigational product was administered.
- Participants also must be considered by the investigator to have benefited from galcanezumab treatment and must have exhausted alternative therapies for the prevention of migraine.
- Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.
- Current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (CGRP) antibody.
- Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab.
- History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo * Double-blind treatment phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months. * Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they receive 240 milligram (mg) galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months. * Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered. Placebo Galcanezumab * Double-blind treatment phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months. * Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they receive 240 milligram (mg) galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months. * Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered. Galcanezumab 120 mg Galcanezumab * Double-blind treatment phase: Participants received loading dose of 240 mg of galcanezumab at first dosing visit followed 120 mg galcanezumab once a month by SC injection for 2 months. * Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months. * Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered. Galcanezumab 240 mg Galcanezumab * Double-blind treatment phase: Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months. * Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months. * Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered. Israel Addendum Galcanezumab Eligible participants from main study were enrolled in Israel addendum. Participants received 120mg or 240mg galcanezumab SC once a month, at the discretion of the investigator, for up to 3 years or until Israel's Ministry of Health's conditions for continued access cease to be met, whichever occurs first.
- Primary Outcome Measures
Name Time Method Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHD) Baseline, Month 1 through Month 3 MHD: A calendar day on which a migraine headache or probable migraine headache occurred.
Overall mean is derived from the average of months 1 to 3 from mixed model repeated measures (MMRM) model. Least square(LS) Mean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Role-function Restrictive Domain Baseline, Month 3 MSQ v2.1 is a health status instrument, with a 4-week recall period, developed to address physical and emotional limitations of specific concern to individuals with migraine. Addressing the impact of migraine on work or daily activities, relationships with family \& friends, leisure time, productivity, concentration, energy, tiredness \& feelings. It consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);\&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6),\& are reverse-recoded (value 6 to 1) before the domain scores are calculated. Total raw scores for each domain is the sum of the final item value for all of the items in that domain. After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status \& a positive change in scores reflecting functional improvement.
Number of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days Baseline, Month 1 through Month 3 MHD: A calendar day on which a migraine headache or probable migraine headache occurred.
Overall Mean Change From Baseline in Headache Hours Baseline, Month 1 through Month 3 Overall mean is derived from the average of months 1 to 3 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month,baseline, and baseline by month as fixed effects.
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache Baseline, Month 1 through Month 3 Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred.
Overall mean is derived from the average of months 1 to 3 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month,baseline, and baseline by month as fixed effects.Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score Baseline, Month 3 The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability. LSMean was calculated using Analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, and baseline value as fixed effects.
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab Baseline through Month 3 Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab.
Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score Baseline, Month 3 PGI-S scale is a participant-rated instrument that measures participants own global impression of their illness severity. The participant was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options were from 1 ("normal, not at all ill") to 7 ("extremely ill"). LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.
Percentage of Participants Developing Treatment Emergent Anti-drug Antibodies (ADA) to Galcanezumab Month 1 through Month 3 A Treatment Emergent Anti-Drug Antibodies (TE ADA) evaluable participant is considered to be TE ADA+ if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post baseline result of ADA Present with titer \>= 20.
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) Month 3 Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).
Serum Concentrations of Galcanezumab Month 3 Serum concentrations of Galcanezumab
Trial Locations
- Locations (58)
Pharmacology Research Institute, Newport Beach
🇺🇸Newport Beach, California, United States
Boston Clinical Trials Inc
🇺🇸Boston, Massachusetts, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Optimus Medical Group
🇺🇸San Francisco, California, United States
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
🇨🇦Ottawa, Canada
21st Century Neurology
🇺🇸Phoenix, Arizona, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Pharmacology Research Institute, Los Alamitos
🇺🇸Los Alamitos, California, United States
Pharmacology Research Institute, Encino
🇺🇸Encino, California, United States
Desert Valley Research
🇺🇸Rancho Mirage, California, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
Colorado Neurological Institute
🇺🇸Englewood, Colorado, United States
Avail Clinical Research LLC
🇺🇸DeLand, Florida, United States
Associated Neurologists of Southern Connecticut
🇺🇸Fairfield, Connecticut, United States
|Renstar Medical Research
🇺🇸Ocala, Florida, United States
Premiere Research Institute at Palm Beach Neurology
🇺🇸West Palm Beach, Florida, United States
Compass Research
🇺🇸Oviedo, Florida, United States
Christie Clinic, LLC
🇺🇸Champaign, Illinois, United States
PharmaSite Research Inc
🇺🇸Baltimore, Maryland, United States
Phoenix Medical Research, Inc
🇺🇸Prairie Village, Kansas, United States
Midwest Institute for Clinical Research
🇺🇸Indianapolis, Indiana, United States
Heartland Research Associates
🇺🇸Wichita, Kansas, United States
Clinical Research Institute
🇺🇸Minneapolis, Minnesota, United States
Healthcare Research Network - Hazelwood
🇺🇸Hazelwood, Missouri, United States
Albuquerque Clinical Trials
🇺🇸Albuquerque, New Mexico, United States
Island Neuro Associates,PC
🇺🇸Plainview, New York, United States
Dent Neurological Institute
🇺🇸Amherst, New York, United States
Univ of Cincinnati College of Medicine
🇺🇸Cincinnati, Ohio, United States
Preferred Primary Care Physicians
🇺🇸Pleasant Hills, Pennsylvania, United States
ClinVest
🇺🇸Springfield, Missouri, United States
Healthcare Research Consultant
🇺🇸Tulsa, Oklahoma, United States
Abington Neurological Associates
🇺🇸Willow Grove, Pennsylvania, United States
Coastal Carolina Research Center, Inc.
🇺🇸Mount Pleasant, South Carolina, United States
Headache Medicine Specialist of North Texas
🇺🇸Dallas, Texas, United States
BG Neurology
🇺🇸Spartanburg, South Carolina, United States
Dean Foundation for Health Research and Education
🇺🇸Middleton, Wisconsin, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇬🇧Stoke-on-Trent, United Kingdom
Instituto de Neurologia Dra. Ivonne Fraga
🇵🇷San Juan, Puerto Rico
Office of Dr. Ruddy Guerra
🇵🇷Manati, Puerto Rico
GCM Medical Group PSC
🇵🇷San Juan, Puerto Rico
Neuro GI Wellness Center
🇵🇷San Juan, Puerto Rico
Clinical Neuroscience Solutions Inc
🇺🇸Jacksonville, Florida, United States
FutureSearch Trials of Neurology and Sleep Lab
🇺🇸Austin, Texas, United States
Robbins Headache Clinic
🇺🇸Riverwoods, Illinois, United States
Northwest Clinical Trials
🇺🇸Boise, Idaho, United States
ClinSearch
🇺🇸Chattanooga, Tennessee, United States
Fullerton Neurology and Headache Center
🇺🇸Fullerton, California, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Advanced Neurosciences Research, LLC
🇺🇸Fort Collins, Colorado, United States
University of South Carolina
🇺🇸Columbia, South Carolina, United States
Sentara Neurology Specialists
🇺🇸Virginia Beach, Virginia, United States
Foothill Family Clinic
🇺🇸Salt Lake City, Utah, United States
Health Research of Hampton Roads Inc
🇺🇸Newport News, Virginia, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Psychiatric Inst of Florida-Clinical Neuroscience Solutions
🇺🇸Orlando, Florida, United States
Michigan Head, Pain and Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
Clinical Trials of South Carolina
🇺🇸Charleston, South Carolina, United States