Evaluation of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-1 Study
- Registration Number
- NCT02614183
- 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 episodic migraine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 862
- Have a diagnosis of episodic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 or 1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, migraine onset prior to age 50 and MONTHLY frequency of 4-14 Migraine Headache Days (MHD).
- 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 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 Placebo given by SC injection once a month for 6 months. Galcanezumab 240mg Galcanezumab Galcanezumab 240mg given by SC injection once a month for 6 months. Galcanezumab 120mg Galcanezumab Galcanezumab given by subcutaneous (SC) injection at 120mg dose once a month for 6 months. Participants received a loading dose of 240mg (2 injections of 120mg each) was administered at visit 3 only.
- Primary Outcome Measures
Name Time Method Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Baseline, Month 1 through Month 6 Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred.
Migraine Headache : A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B):
A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia;
Overall mean is derived from the average of months 1 to 6 from mixed model repeated measures (MMRM) model. Least Square (LS) mean was calculated using mixed model repeated measures (MMRM) model with treatment, pooled country, month, and treatment by month, baseline, and baseline by month as fixed effects.
- Secondary Outcome Measures
Name Time Method Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) Month 6 Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).
Overall Mean Change From Baseline in Headache Hours Baseline, Month 1 through Month 6 Headache Hours is calculated as the total number of headache hours on which a headache occurred. Overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month and baseline MHD category.
Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score Baseline, Month 6 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 MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors.Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 (v2.1) Role Function Restrictive Domain Baseline, Month 4 through Month 6 MSQ v2.1 was developed to address physical \& emotional limitations of specific concern to individuals with migraine.
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.
Mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline by month \& baseline MHD category as fixed factors.Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab Month 1 through Month 6 Treatment emergent (TE) ADA evaluable participant is considered to be TE ADA+ if the subject 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 \>= 1: 20.
Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days Baseline, Month 1 through Month 6 Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred.
Mean is derived from the average of months 1 to 6 from generalized linear mixed model repeated measures. Mean percentages of participants were calculated with a generalized linear mixed model repeated measures method with treatment, month and treatment by month, baseline.Pharmacokinetics (PK): Serum Concentrations of Galcanezumab Month 6 Pharmacokinetics (PK): Serum Concentrations of Galcanezumab.
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 6 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 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed effects.Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Rating Baseline, Month 4 through Month 6 The PGI-S scale is a patient-rated instrument that measures patients own global impression of their illness severity. The patient 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"). Mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors.
Trial Locations
- Locations (84)
Orange Grove Family Practice
🇺🇸Tucson, Arizona, United States
Territory Neurology & Research Institute
🇺🇸Tucson, Arizona, United States
Arkansas Clinical Research
🇺🇸Little Rock, Arkansas, United States
Pharmacology Research Institute, Newport Beach
🇺🇸Newport Beach, California, United States
Tooraj Joseph Raoof M.D., Inc.
🇺🇸Encino, California, United States
Irvine Clinical Research Center
🇺🇸Irvine, California, United States
Fullerton Neurology and Headache Center
🇺🇸Fullerton, California, United States
Sun Valley Research Center
🇺🇸Imperial, California, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Suncoast Clinical Research
🇺🇸New Port Richey, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Sensible Healthcare
🇺🇸Ocoee, Florida, United States
Compass Research
🇺🇸Oviedo, Florida, United States
Accord Clinical Research, LLC
🇺🇸Port Orange, Florida, United States
Roskamp Institute
🇺🇸Sarasota, Florida, United States
Infinity Clinical Reserach . LLC
🇺🇸Sunrise, Florida, United States
Premiere Research Institute at Palm Beach Neurology
🇺🇸West Palm Beach, Florida, United States
Advanced Clinical Research LLC
🇺🇸Meridian, Idaho, United States
Healthcare Research Network - Blue Island
🇺🇸Blue Island, Illinois, United States
Community Clinical Research Center
🇺🇸Anderson, Indiana, United States
Investigative Clinical Research of Indiana, LLC
🇺🇸Elwood, Indiana, United States
Deaconess Clinic Inc
🇺🇸Newburgh, Indiana, United States
Integrated Clinical Trial Services, Inc.
🇺🇸West Des Moines, Iowa, United States
Otri-Med Corporation
🇺🇸Edgewood, Kentucky, United States
Healthy Perspectives Innovative Mental Health Services, PL
🇺🇸Nashua, New Hampshire, United States
ClinVest
🇺🇸Springfield, Missouri, United States
Albuquerque Clinical Trials
🇺🇸Albuquerque, New Mexico, United States
NYU Langone
🇺🇸New York, New York, United States
Dent Neurological Institute
🇺🇸Amherst, New York, United States
Central New York Clinical Research
🇺🇸Manlius, New York, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
Fieve Clincial Services
🇺🇸New York, New York, United States
Metrolina Neurological Associates, PA
🇺🇸Charlotte, North Carolina, United States
Headache Wellness Center
🇺🇸Greensboro, North Carolina, United States
Medical College of Ohio at Toledo
🇺🇸Toledo, Ohio, United States
Healthcare Research Consultant
🇺🇸Tulsa, Oklahoma, United States
Lehigh Center for Clinical Research
🇺🇸Allentown, Pennsylvania, United States
Abington Neurological Associates
🇺🇸Willow Grove, Pennsylvania, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
ClinSearch
🇺🇸Chattanooga, Tennessee, United States
8 Medical Park
🇺🇸Columbia, South Carolina, United States
Clinical Research Associates
🇺🇸Nashville, Tennessee, United States
Protenium Clinical Research
🇺🇸Hurst, Texas, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
Vancouver Clinic
🇺🇸Vancouver, Washington, United States
Clinical Research Associates of Tidewater
🇺🇸Norfolk, Virginia, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States
Office of Dr. Ruddy Guerra
🇵🇷Manati, Puerto Rico
NuFrontiers Clinical Research LLC
🇵🇷Rio Piedras, Puerto Rico
Clinical Research Puerto Rico, Inc.
🇵🇷San Juan, Puerto Rico
GCM Medical Group PSC
🇵🇷San Juan, Puerto Rico
Neuro GI Wellness Center
🇵🇷San Juan, Puerto Rico
Instituto de Neurologia Dra. Ivonne Fraga
🇵🇷San Juan, Puerto Rico
Advanced Clinical Research
🇺🇸West Jordan, Utah, United States
Meridien Research
🇺🇸Bradenton, Florida, United States
Desert Valley Research
🇺🇸Rancho Mirage, California, United States
PharmaSite Research Inc
🇺🇸Baltimore, Maryland, United States
Rapid Medical Research Inc
🇺🇸Cleveland, Ohio, United States
Boston Clinical Trials Inc
🇺🇸Boston, Massachusetts, United States
Preferred Primary Care Physicians
🇺🇸Pittsburgh, Pennsylvania, United States
Clinical Investigation Specialists Inc
🇺🇸Kenosha, Wisconsin, United States
Phoenix Medical Research, Inc
🇺🇸Prairie Village, Kansas, United States
Advanced Neurosciences Research, LLC
🇺🇸Fort Collins, Colorado, United States
MCB Clinical Research Centers
🇺🇸Colorado Springs, Colorado, United States
Colorado Neurological Institute
🇺🇸Englewood, Colorado, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Midwest Institute for Clinical Research
🇺🇸Indianapolis, Indiana, United States
Clinical Research Institute
🇺🇸Minneapolis, Minnesota, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
Radiant Research - San Antonio
🇺🇸San Antonio, Texas, United States
Mile High Research Center
🇺🇸Denver, Colorado, United States
Summit Research Network Inc
🇺🇸Portland, Oregon, 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.
🇨🇦Waterloo, Canada
Psychiatric Inst of Florida-Clinical Neuroscience Solutions
🇺🇸Orlando, Florida, United States
L-Marc Research Center
🇺🇸Louisville, Kentucky, United States
Michigan Head, Pain and Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
Clinical Trials of South Carolina
🇺🇸Charleston, South Carolina, United States
FutureSearch Trials
🇺🇸Austin, Texas, United States
National Clinical Research - Richmond
🇺🇸Richmond, Virginia, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States