Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 Study
EVOLVE-2
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Migraine - the EVOLVE-2 Study
3 other identifiers
interventional
986
12 countries
113
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2015
Typical duration for phase_3
113 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2015
CompletedFirst Posted
Study publicly available on registry
November 25, 2015
CompletedStudy Start
First participant enrolled
December 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2018
CompletedResults Posted
Study results publicly available
January 7, 2019
CompletedJune 17, 2020
June 1, 2020
1.3 years
November 23, 2015
August 23, 2018
June 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days
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.
Baseline, Month 1 through Month 6
Secondary Outcomes (9)
Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75%, and 100% in Monthly Migraine Headache Days
Baseline, Month 1 through Month 6
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
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
Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) Rating
Baseline, Month 4 through Month 6
Overall Mean Change From Baseline in Headache Hours
Baseline, Month 1 through Month 6
- +4 more secondary outcomes
Study Arms (6)
Galcanezumab 120mg
EXPERIMENTALGalcanezumab 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
EXPERIMENTALGalcanezumab 240mg given by SC injection once a month for 6 months.
Placebo
PLACEBO COMPARATORPlacebo given by SC injection once a month for 6 months.
Galcanezumab 120mg Maximum Extended Enrollment Cohort
EXPERIMENTALGalcanezumab 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 Maximum Extended Enrollment Cohort
EXPERIMENTALGalcanezumab 240mg given by SC injection once a month for 6 months.
Placebo Maximum Extended Enrollment Cohort
PLACEBO COMPARATORPlacebo given by SC injection once a month for 6 months.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (113)
21st Century Neurology
Phoenix, Arizona, 85004, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Axiom Research
Apple Valley, California, 92307, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Catalina Research Institute, LLC
Montclair, California, 91763, United States
Pacific Research Partners, LLC
Oakland, California, 94607, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Optimus Medical Group
San Francisco, California, 94102, United States
Schuster Medical Research Institute
Sherman Oaks, California, 91403, United States
IMMUNOe International Research Centers
Centennial, Colorado, 80112, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Sunrise Clinical Research
Hollywood, Florida, 33021, United States
Westside Center for Clinical Research
Jacksonville, Florida, 32205, United States
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, 32256, United States
Sensible Healthcare
Ocoee, Florida, 34761, United States
Meridien Research
Tampa, Florida, 33634, United States
Atlanta Center of Medical Research
Atlanta, Georgia, 30331, United States
Christie Clinic, LLC
Champaign, Illinois, 61820, United States
Diamond Headache Clinic
Chicago, Illinois, 60642, United States
Josephson Wallack Munshower Neurology
Indianapolis, Indiana, 46256, United States
Heartland Research Associates
Wichita, Kansas, 67205, United States
Novex Clinical Research
New Bedford, Massachusetts, 02740, United States
QUEST Research Institute
Farmington Hills, Michigan, 48334, United States
Healthcare Research Network - Hazelwood
Hazelwood, Missouri, 63042, United States
Nevada Headache Institute
Las Vegas, Nevada, 89113, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102, United States
Regional Clinical Research
Binghamton, New York, 13760, United States
SPRI Clinical Trials, LLC.
Brooklyn, New York, 11235, United States
High Point Clinical Trials Center
High Point, North Carolina, 27265, United States
Neurology & Neuroscience Associates, Inc.
Akron, Ohio, 44320, United States
Univ of Cincinnati College of Medicine
Cincinnati, Ohio, 45219, United States
Urgent Care Specialists, LLC
Columbus, Ohio, 43214, United States
Urgent Care Specialists, LLC
Dayton, Ohio, 45424, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Oregon Neurology Associates
Springfield, Oregon, 97477, United States
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, 19114, United States
Mountain View Clinical Research, Inc
Greer, South Carolina, 29651, United States
Coastal Carolina Research Center, Inc.
Mt. Pleasant, South Carolina, 29464, United States
FutureSearch Trials
Dallas, Texas, 75231, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Clinpoint Trial, LLC
Waxahachie, Texas, 75165, United States
Foothill Family Clinic
Salt Lake City, Utah, 84109, United States
Jordan River Family Medicine
South Jordan, Utah, 84095, United States
Health Research of Hampton Roads Inc
Newport News, Virginia, 23606, United States
Sentara Neurology Specialists
Virginia Beach, Virginia, 23456, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007-4209, United States
Polyclinic
Seattle, Washington, 98104, United States
Dean Foundation for Health Research and Education
Middleton, Wisconsin, 53562, 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.
Buenos Aires, C1046AAQ, Argentina
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Ciudad Autonoma de Buenos Aire, C1012AAR, Argentina
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Ciudad Autonoma de Buenos Aire, C1013AAB, Argentina
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Ciudad Autonoma de Buenos Aire, C1128AAF, Argentina
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Brno, 656 91, Czechia
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Kladno, 27201, Czechia
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Prague, 100 00, Czechia
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Prague, 120 00, Czechia
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Prague, 160 00, Czechia
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Prague, 182 00, Czechia
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Berlin, 10117, Germany
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Bielefeld, 33647, Germany
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Bochum, 44787, Germany
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Bochum, 44797, Germany
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Essen, 45147, Germany
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Halle, 06120, Germany
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Hamburg, 20246, Germany
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Jena, 07747, Germany
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Kassel, 34121, Germany
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Königstein, 61462, Germany
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Prien am Chiemsee, 83209, Germany
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TĂ¼bingen, 72076, Germany
Hillel Yaffe
Hadera, 38100, Israel
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Haifa, 3525408, Israel
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Kfar Saba, 4420122, Israel
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Ramat Gan, 5266202, Israel
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Aguascalientes, 20217, Mexico
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CuliacĂ¡n, 80020, Mexico
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Mexico City, 03740, Mexico
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MĂ©rida, 97070, Mexico
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MĂ©xico, 03310, Mexico
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Amsterdam, 1078 VV, Netherlands
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Geleen, 6162 BG, Netherlands
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Leiden, 2333 ZA, Netherlands
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Nijmegen, 6532 SZ, Netherlands
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Tilburg, 5042 AD, Netherlands
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Zwolle, 8025 AB, Netherlands
Cortex, PSC
Las Piedras, 00771, Puerto Rico
SomniCare Sleep Institute
San Juan, 00918, Puerto Rico
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Hwaseong-si, 18450, South Korea
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Seoul, 01830, South Korea
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Seoul, 03080, South Korea
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Seoul, 03181, South Korea
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Seoul, 06351, South Korea
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Seoul, 07441, South Korea
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Seoul, 08308, South Korea
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Barcelona, 08035, Spain
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Barcelona, 08907, Spain
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Elda, 03600, Spain
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Santander, 39008, Spain
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Valencia, 46010, Spain
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Valencia, 46026, Spain
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Valladolid, 47005, Spain
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Kaohsiung City, 80756, Taiwan
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Taichung, 43761, Taiwan
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Tainan, 70142, Taiwan
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Tainan, 71004, Taiwan
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Taipei, 11217, Taiwan
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Taipei, 220, Taiwan
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Glasgow, G51 4TF, United Kingdom
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Hull, HU3 2JZ, United Kingdom
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Liverpool, L9 7LJ, United Kingdom
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London, SE5 9RS, United Kingdom
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Stoke-on-Trent, ST4 6QG, United Kingdom
Related Publications (16)
Ailani J, Kuruppu DK, Rettiganti M, Oakes T, Schroeder K, Wietecha L, Port M, Blumenfeld AM. Does "wearing off" of efficacy occur in galcanezumab-treated patients at the end of the monthly treatment cycle? Post hoc analyses of four phase III randomized trials. Headache. 2022 Feb;62(2):198-207. doi: 10.1111/head.14257. Epub 2022 Jan 25.
PMID: 35076090DERIVEDCitrome L, Sanchez Del Rio M, Dong Y, Nichols RM, Tockhorn-Heidenreich A, Foster SA, Stauffer VL. Benefit-Risk Assessment of Galcanezumab Versus Placebo for the Treatment of Episodic and Chronic Migraine Using the Metrics of Number Needed to Treat and Number Needed to Harm. Adv Ther. 2021 Aug;38(8):4442-4460. doi: 10.1007/s12325-021-01848-x. Epub 2021 Jul 15.
PMID: 34264500DERIVEDJedynak J, Eross E, Gendolla A, Rettiganti M, Stauffer VL. Shift from high-frequency to low-frequency episodic migraine in patients treated with Galcanezumab: results from two global randomized clinical trials. J Headache Pain. 2021 May 28;22(1):48. doi: 10.1186/s10194-021-01222-w.
PMID: 34049484DERIVEDPozo-Rosich P, Samaan KH, Schwedt TJ, Nicholson RA, Rettiganti M, Pearlman EM. Galcanezumab Provides Consistent Efficacy Throughout the Dosing Interval Among Patients with Episodic and Chronic Migraine: A Post Hoc Analysis. Adv Ther. 2021 Jun;38(6):3154-3165. doi: 10.1007/s12325-021-01708-8. Epub 2021 May 5.
PMID: 33950375DERIVEDAment M, Day K, Stauffer VL, Skljarevski V, Rettiganti M, Pearlman E, Aurora SK. Effect of galcanezumab on severity and symptoms of migraine in phase 3 trials in patients with episodic or chronic migraine. J Headache Pain. 2021 Feb 6;22(1):6. doi: 10.1186/s10194-021-01215-9.
PMID: 33549036DERIVEDKuruppu DK, North JM, Kovacik AJ, Dong Y, Pearlman EM, Hutchinson SL. Onset, Maintenance, and Cessation of Effect of Galcanezumab for Prevention of Migraine: A Narrative Review of Three Randomized Placebo-Controlled Trials. Adv Ther. 2021 Mar;38(3):1614-1626. doi: 10.1007/s12325-021-01632-x. Epub 2021 Feb 5.
PMID: 33544305DERIVEDDodick DW, Doty EG, Aurora SK, Ruff DD, Stauffer VL, Jedynak J, Dong Y, Pearlman EM. Medication overuse in a subgroup analysis of phase 3 placebo-controlled studies of galcanezumab in the prevention of episodic and chronic migraine. Cephalalgia. 2021 Mar;41(3):340-352. doi: 10.1177/0333102420966658. Epub 2020 Nov 3.
PMID: 33143451DERIVEDAilani J, Andrews JS, Rettiganti M, Nicholson RA. Impact of galcanezumab on total pain burden: findings from phase 3 randomized, double-blind, placebo-controlled studies in patients with episodic or chronic migraine (EVOLVE-1, EVOLVE-2, and REGAIN trials). J Headache Pain. 2020 Oct 17;21(1):123. doi: 10.1186/s10194-020-01190-7.
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Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Sponsor is also masked.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2015
First Posted
November 25, 2015
Study Start
December 4, 2015
Primary Completion
March 29, 2017
Study Completion
October 5, 2018
Last Updated
June 17, 2020
Results First Posted
January 7, 2019
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.