Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 Study
- Registration Number
- NCT02614196
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as galcanezumab in participants with episodic migraine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 986
- Have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta version (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 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 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 Placebo given by SC injection once a month for 6 months. Placebo Maximum Extended Enrollment Cohort Placebo Placebo given by SC injection once a month for 6 months. Galcanezumab 240mg Maximum Extended Enrollment Cohort Galcanezumab Galcanezumab 240mg given by SC injection once a month for 6 months. Galcanezumab 120mg Galcanezumab Galcanezumab 240mg given as loading dose at first dosing visit followed by galcanezumab 120mg once a month for 5 months by subcutaneous (SC) injection. Galcanezumab 240mg Galcanezumab Galcanezumab 240mg given by SC injection once a month for 6 months. Galcanezumab 120mg Maximum Extended Enrollment Cohort Galcanezumab Galcanezumab 240mg given as loading dose at first dosing visit followed by galcanezumab 120mg once a month for 5 months by subcutaneous (SC) injection.
- 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 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.Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 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.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 Patient Global Impression of Severity (PGI-S) Rating Baseline, Month 4 through Month 6 The PGI-S scale is a participant-rated instrument that measures patients 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"). 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.
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 in 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.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.
Pharmacokinetics (PK): Serum Concentrations of Galcanezumab Month 6 Pharmacokinetics (PK): Serum Concentrations of Galcanezumab.
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) Month 6 Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).
Trial Locations
- Locations (53)
Neurology & Neuroscience Associates, Inc.
🇺🇸Akron, Ohio, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
Axiom Research
🇺🇸Apple Valley, California, United States
Pacific Research Partners, LLC
🇺🇸Oakland, California, United States
IMMUNOe International Research Centers
🇺🇸Centennial, Colorado, United States
Clinical Research of South Florida
🇺🇸Coral Gables, Florida, United States
Clinical Neuroscience Solutions Inc
🇺🇸Jacksonville, Florida, United States
Sensible Healthcare
🇺🇸Ocoee, Florida, United States
Christie Clinic, LLC
🇺🇸Champaign, Illinois, United States
Novex Clinical Research
🇺🇸New Bedford, Massachusetts, United States
Healthcare Research Network - Hazelwood
🇺🇸Hazelwood, Missouri, United States
Heartland Research Associates
🇺🇸Wichita, Kansas, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
Albuquerque Clinical Trials
🇺🇸Albuquerque, New Mexico, United States
Regional Clinical Research
🇺🇸Binghamton, New York, United States
High Point Clinical Trials Center
🇺🇸High Point, North Carolina, United States
SPRI Clinical Trials, LLC.
🇺🇸Brooklyn, New York, United States
Urgent Care Specialists, LLC
🇺🇸Dayton, Ohio, United States
Oregon Neurology Associates
🇺🇸Springfield, Oregon, United States
Mountain View Clinical Research, Inc
🇺🇸Greer, South Carolina, United States
FutureSearch Trials
🇺🇸Dallas, Texas, United States
Clinpoint Trial, LLC
🇺🇸Waxahachie, Texas, United States
Coastal Carolina Research Center, Inc.
🇺🇸Mount Pleasant, South Carolina, United States
Jordan River Family Medicine
🇺🇸South Jordan, Utah, United States
Hillel Yaffe
🇮🇱Hadera, Israel
Health Research of Hampton Roads Inc
🇺🇸Newport News, Virginia, United States
Northwest Clinical Research Center
🇺🇸Bellevue, 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
Dean Foundation for Health Research and Education
🇺🇸Middleton, Wisconsin, 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
🇰🇷Seoul, Korea, Republic of
Cortex, PSC
🇵🇷Las Piedras, Puerto Rico
SomniCare Sleep Institute
🇵🇷San Juan, Puerto Rico
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Atlanta Center of Medical Research
🇺🇸Atlanta, Georgia, United States
Clinical Research of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Polyclinic
🇺🇸Seattle, Washington, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Diamond Headache Clinic
🇺🇸Chicago, Illinois, United States
Josephson Wallack Munshower Neurology
🇺🇸Indianapolis, Indiana, United States
Sentara Neurology Specialists
🇺🇸Virginia Beach, Virginia, United States
Sunrise Clinical Research
🇺🇸Hollywood, Florida, United States
Univ of Cincinnati College of Medicine
🇺🇸Cincinnati, Ohio, United States
QUEST Research Institute
🇺🇸Farmington Hills, Michigan, United States
Nevada Headache Institute
🇺🇸Las Vegas, Nevada, United States
Clinical Trial Network
🇺🇸Houston, Texas, United States
21st Century Neurology
🇺🇸Phoenix, Arizona, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Optimus Medical Group
🇺🇸San Francisco, California, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Foothill Family Clinic
🇺🇸Salt Lake City, Utah, United States
Schuster Medical Research Institute
🇺🇸Sherman Oaks, California, United States
Westside Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Meridien Research
🇺🇸Tampa, Florida, United States