Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 Study
NCT ID: NCT02614196
Last Updated: 2020-06-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
986 participants
INTERVENTIONAL
2015-12-04
2018-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Galcanezumab 120mg
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
Administered SC
Galcanezumab 240mg
Galcanezumab 240mg given by SC injection once a month for 6 months.
Galcanezumab
Administered SC
Placebo
Placebo given by SC injection once a month for 6 months.
Placebo
Administered SC
Galcanezumab 120mg Maximum Extended Enrollment Cohort
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
Administered SC
Galcanezumab 240mg Maximum Extended Enrollment Cohort
Galcanezumab 240mg given by SC injection once a month for 6 months.
Galcanezumab
Administered SC
Placebo Maximum Extended Enrollment Cohort
Placebo given by SC injection once a month for 6 months.
Placebo
Administered SC
Interventions
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Galcanezumab
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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21st Century Neurology
Phoenix, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Axiom Research
Apple Valley, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Pacific Research Partners, LLC
Oakland, California, United States
Medical Center for Clinical Research
San Diego, California, United States
Optimus Medical Group
San Francisco, California, United States
Schuster Medical Research Institute
Sherman Oaks, California, United States
IMMUNOe International Research Centers
Centennial, Colorado, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Sunrise Clinical Research
Hollywood, Florida, United States
Westside Center for Clinical Research
Jacksonville, Florida, United States
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, United States
Sensible Healthcare
Ocoee, Florida, United States
Meridien Research
Tampa, Florida, United States
Atlanta Center of Medical Research
Atlanta, Georgia, United States
Christie Clinic, LLC
Champaign, Illinois, United States
Diamond Headache Clinic
Chicago, Illinois, United States
Josephson Wallack Munshower Neurology
Indianapolis, Indiana, United States
Heartland Research Associates
Wichita, Kansas, United States
Novex Clinical Research
New Bedford, Massachusetts, United States
QUEST Research Institute
Farmington Hills, Michigan, United States
Healthcare Research Network - Hazelwood
Hazelwood, Missouri, United States
Nevada Headache Institute
Las Vegas, Nevada, 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
SPRI Clinical Trials, LLC.
Brooklyn, New York, United States
High Point Clinical Trials Center
High Point, North Carolina, United States
Neurology & Neuroscience Associates, Inc.
Akron, Ohio, United States
Univ of Cincinnati College of Medicine
Cincinnati, Ohio, United States
Urgent Care Specialists, LLC
Columbus, Ohio, United States
Urgent Care Specialists, LLC
Dayton, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Oregon Neurology Associates
Springfield, Oregon, United States
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, United States
Mountain View Clinical Research, Inc
Greer, South Carolina, United States
Coastal Carolina Research Center, Inc.
Mt. Pleasant, South Carolina, United States
FutureSearch Trials
Dallas, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Clinpoint Trial, LLC
Waxahachie, Texas, United States
Foothill Family Clinic
Salt Lake City, Utah, United States
Jordan River Family Medicine
South Jordan, Utah, United States
Health Research of Hampton Roads Inc
Newport News, Virginia, United States
Sentara Neurology Specialists
Virginia Beach, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Polyclinic
Seattle, Washington, United States
Dean Foundation for Health Research and Education
Middleton, Wisconsin, United States
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Buenos Aires, , Argentina
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Ciudad Autonoma de Buenos Aire, , Argentina
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Ciudad Autonoma de Buenos Aire, , Argentina
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Ciudad Autonoma de Buenos Aire, , Argentina
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Brno, , Czechia
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Kladno, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Berlin, , Germany
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Bielefeld, , Germany
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Bochum, , Germany
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Bochum, , Germany
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Essen, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Jena, , Germany
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Kassel, , Germany
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Königstein, , Germany
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Prien am Chiemsee, , Germany
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Tübingen, , Germany
Hillel Yaffe
Hadera, , Israel
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Haifa, , Israel
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Kfar Saba, , Israel
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Ramat Gan, , Israel
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Aguascalientes, , Mexico
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Culiacán, , Mexico
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Mexico City, , Mexico
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Mérida, , Mexico
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México, , Mexico
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Amsterdam, , Netherlands
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Geleen, , Netherlands
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Leiden, , Netherlands
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Nijmegen, , Netherlands
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Tilburg, , Netherlands
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Zwolle, , Netherlands
Cortex, PSC
Las Piedras, , Puerto Rico
SomniCare Sleep Institute
San Juan, , Puerto Rico
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Hwaseong-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Barcelona, , Spain
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Elda, , Spain
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Santander, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Valladolid, , Spain
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Glasgow, , United Kingdom
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Hull, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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Stoke-on-Trent, , United Kingdom
Countries
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References
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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.
Citrome 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.
Jedynak 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.
Pozo-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.
Ament 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.
Kuruppu 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.
Dodick 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.
Ailani 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.
Stauffer 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.
Bangs 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.
Kielbasa 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.
Silberstein 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.
Stauffer 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.
Forderreuther 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.
Nichols 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.
Skljarevski V, Matharu M, Millen BA, Ossipov MH, Kim BK, Yang JY. Efficacy and safety of galcanezumab for the prevention of episodic migraine: Results of the EVOLVE-2 Phase 3 randomized controlled clinical trial. Cephalalgia. 2018 Jul;38(8):1442-1454. doi: 10.1177/0333102418779543. Epub 2018 May 31.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here for more information about this study: Evaluation of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 Study
Other Identifiers
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I5Q-MC-CGAH
Identifier Type: OTHER
Identifier Source: secondary_id
2015-001882-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15768
Identifier Type: -
Identifier Source: org_study_id
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