Evaluation of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-1 Study
EVOLVE-1
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Migraine - the EVOLVE-1 Study
2 other identifiers
interventional
862
3 countries
95
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2015
Typical duration for phase_3
95 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
November 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2018
CompletedResults Posted
Study results publicly available
November 29, 2018
CompletedJune 17, 2020
June 1, 2020
1.3 years
November 23, 2015
October 8, 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 (v2.1) 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 the 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 (3)
Galcanezumab 120mg
EXPERIMENTALGalcanezumab 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.
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
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 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 (95)
Territory Neurology & Research Institute
Tucson, Arizona, 85704, United States
Orange Grove Family Practice
Tucson, Arizona, 85741, United States
Arkansas Clinical Research
Little Rock, Arkansas, 72205, United States
Advanced Clinical Research
Carmichael, California, 95608, United States
Pharmacology Research Institute, Newport Beach
Encino, California, 91316, United States
Tooraj Joseph Raoof M.D., Inc.
Encino, California, 91436, United States
Fullerton Neurology and Headache Center
Fullerton, California, 92835, United States
Sun Valley Research Center
Imperial, California, 92251, United States
Irvine Clinical Research Center
Irvine, California, 92618, United States
Pharmacology Research Institute, Newport Beach
Los Alamitos, California, 90720, United States
Pharmacology Research Institute, Newport Beach
Newport Beach, California, 92660, United States
Desert Valley Research
Rancho Mirage, California, 92270, United States
Anderson Clinical Research
Redlands, California, 92374, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Alpine Clinical Research Center
Boulder, Colorado, 80301, United States
MCB Clinical Research Centers
Colorado Springs, Colorado, 80910, United States
Mile High Research Center
Denver, Colorado, 80218, United States
Colorado Neurological Institute
Englewood, Colorado, 80113, United States
Advanced Neurosciences Research, LLC
Fort Collins, Colorado, 80528, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Meridien Research
Bradenton, Florida, 34201, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Sensible Healthcare
Ocoee, Florida, 34761, United States
Psychiatric Inst of Florida-Clinical Neuroscience Solutions
Orlando, Florida, 32801, United States
Compass Research
Oviedo, Florida, 32765, United States
Accord Clinical Research, LLC
Port Orange, Florida, 32129, United States
Roskamp Institute
Sarasota, Florida, 34243, United States
Infinity Clinical Reserach . LLC
Sunrise, Florida, 33351, United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407, United States
Advanced Clinical Research LLC
Meridian, Idaho, 83642, United States
Healthcare Research Network - Blue Island
Blue Island, Illinois, 60406, United States
Community Clinical Research Center
Anderson, Indiana, 46011, United States
Investigative Clinical Research of Indiana, LLC
Elwood, Indiana, 46036, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, 46260, United States
Deaconess Clinic Inc
Newburgh, Indiana, 47630, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, 50265, United States
Phoenix Medical Research, Inc
Prairie Village, Kansas, 66206, United States
Otri-Med Corporation
Edgewood, Kentucky, 41017, United States
L-Marc Research Center
Louisville, Kentucky, 40213, United States
PharmaSite Research Inc
Baltimore, Maryland, 21208, United States
Boston Clinical Trials Inc
Boston, Massachusetts, 02131, United States
Michigan Head, Pain and Neurological Institute
Ann Arbor, Michigan, 48104, United States
Clinical Research Institute
Minneapolis, Minnesota, 55402, United States
ClinVest
Springfield, Missouri, 65807, United States
Healthy Perspectives Innovative Mental Health Services, PL
Nashua, New Hampshire, 03060, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102, United States
Dent Neurological Institute
Amherst, New York, 14226, United States
Central New York Clinical Research
Manlius, New York, 13104, United States
NYU Langone
New York, New York, 10016, United States
Fieve Clincial Services
New York, New York, 10168, United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609, United States
Metrolina Neurological Associates, PA
Charlotte, North Carolina, 28210, United States
Headache Wellness Center
Greensboro, North Carolina, 27405, United States
Rapid Medical Research Inc
Cleveland, Ohio, 44122, United States
Medical College of Ohio at Toledo
Toledo, Ohio, 43614, United States
Healthcare Research Consultant
Tulsa, Oklahoma, 74135, United States
Summit Research Network Inc
Portland, Oregon, 97210, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104, United States
Preferred Primary Care Physicians
Pittsburgh, Pennsylvania, 15236, United States
Abington Neurological Associates
Willow Grove, Pennsylvania, 19090, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Clinical Trials of South Carolina
Charleston, South Carolina, 29406, United States
8 Medical Park
Columbia, South Carolina, 29203, United States
ClinSearch
Chattanooga, Tennessee, 37421, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Clinical Research Associates
Nashville, Tennessee, 37203, United States
FutureSearch Trials
Austin, Texas, 78731, United States
Protenium Clinical Research
Hurst, Texas, 76054, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Radiant Research - San Antonio
San Antonio, Texas, 78229, United States
Advanced Clinical Research
West Jordan, Utah, 84088, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507, United States
National Clinical Research - Richmond
Richmond, Virginia, 23294, United States
Premier Clinical Research
Spokane, Washington, 99202, United States
Vancouver Clinic
Vancouver, Washington, 98664, United States
Clinical Investigation Specialists Inc
Kenosha, Wisconsin, 53142, 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.
Brampton, L6T 0G1, Canada
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.
Kelowna, V1Y 1Z9, Canada
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.
Mississauga, L4Y 2N8, Canada
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.
Montreal, H3A 2B4, Canada
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, K2G 6E2, Canada
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.
Sherbrooke, J1H1Z1, Canada
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.
Toronto, M9W 4L6, Canada
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.
Vancouver, V6Z 2E8, Canada
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, N2J 1C4, Canada
Office of Dr. Ruddy Guerra
ManatÃ, 00674, Puerto Rico
NuFrontiers Clinical Research LLC
Rio Piedras, 00923, Puerto Rico
Clinical Research Puerto Rico, Inc.
San Juan, 00909, Puerto Rico
GCM Medical Group PSC
San Juan, 00909, Puerto Rico
Instituto de Neurologia Dra. Ivonne Fraga
San Juan, 00918, Puerto Rico
Neuro GI Wellness Center
San Juan, 00926, Puerto Rico
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.
PMID: 33069214DERIVEDStauffer 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.
PMID: 32576229DERIVEDBangs 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.
PMID: 31952501DERIVEDKielbasa 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.
PMID: 31482569DERIVEDSilberstein SD, Stauffer VL, Day KA, Lipsius S, Wilson MC. Galcanezumab in episodic migraine: subgroup analyses of efficacy by high versus low frequency of migraine headaches in phase 3 studies (EVOLVE-1 & EVOLVE-2). J Headache Pain. 2019 Jun 28;20(1):75. doi: 10.1186/s10194-019-1024-x.
PMID: 31253091DERIVEDStauffer VL, Wang S, Voulgaropoulos M, Skljarevski V, Kovacik A, Aurora SK. Effect of Galcanezumab Following Treatment Cessation in Patients With Migraine: Results From 2 Randomized Phase 3 Trials. Headache. 2019 Jun;59(6):834-847. doi: 10.1111/head.13508. Epub 2019 Apr 3.
PMID: 30942898DERIVEDForderreuther S, Zhang Q, Stauffer VL, Aurora SK, Lainez MJA. Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent: data from the phase 3, randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2, and REGAIN studies. J Headache Pain. 2018 Dec 29;19(1):121. doi: 10.1186/s10194-018-0951-2.
PMID: 30594122DERIVEDNichols R, Doty E, Sacco S, Ruff D, Pearlman E, Aurora SK. Analysis of Initial Nonresponders to Galcanezumab in Patients With Episodic or Chronic Migraine: Results From the EVOLVE-1, EVOLVE-2, and REGAIN Randomized, Double-Blind, Placebo-Controlled Studies. Headache. 2019 Feb;59(2):192-204. doi: 10.1111/head.13443. Epub 2018 Nov 21.
PMID: 30462830DERIVEDStauffer VL, Dodick DW, Zhang Q, Carter JN, Ailani J, Conley RR. Evaluation of Galcanezumab for the Prevention of Episodic Migraine: The EVOLVE-1 Randomized Clinical Trial. JAMA Neurol. 2018 Sep 1;75(9):1080-1088. doi: 10.1001/jamaneurol.2018.1212.
PMID: 29813147DERIVED
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
- 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
November 30, 2015
Primary Completion
March 22, 2017
Study Completion
August 9, 2018
Last Updated
June 17, 2020
Results First Posted
November 29, 2018
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.