Evaluation of Galcanezumab in the Prevention of Chronic Migraine
NCT ID: NCT02614261
Last Updated: 2022-05-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1117 participants
INTERVENTIONAL
2015-11-30
2021-07-14
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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Placebo
* Double-blind treatment phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
* Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they receive 240 milligram (mg) galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
* Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
Galcanezumab
Administered SC
Placebo
Administered SC
Galcanezumab 120 mg
* Double-blind treatment phase: Participants received loading dose of 240 mg of galcanezumab at first dosing visit followed 120 mg galcanezumab once a month by SC injection for 2 months.
* Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
* Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
Galcanezumab
Administered SC
Galcanezumab 240 mg
* Double-blind treatment phase: Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.
* Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
* Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
Galcanezumab
Administered SC
Israel Addendum
Eligible participants from main study were enrolled in Israel addendum. Participants received 120mg or 240mg galcanezumab SC once a month, at the discretion of the investigator, for up to 3 years or until Israel's Ministry of Health's conditions for continued access cease to be met, whichever occurs first.
Galcanezumab
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
* Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.
Israel addendum:
* Participants must have completed all phases of main study, including the 4-month post-treatment follow-up phase, during which no investigational product was administered.
* Participants also must be considered by the investigator to have benefited from galcanezumab treatment and must have exhausted alternative therapies for the prevention of migraine.
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
Pharmacology Research Institute, Encino
Encino, California, United States
Fullerton Neurology and Headache Center
Fullerton, California, United States
Pharmacology Research Institute, Los Alamitos
Los Alamitos, California, United States
Pharmacology Research Institute, Newport Beach
Newport Beach, California, United States
Desert Valley Research
Rancho Mirage, California, United States
Anderson Clinical Research
Redlands, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Medical Center for Clinical Research
San Diego, California, United States
Optimus Medical Group
San Francisco, California, United States
Colorado Neurological Institute
Englewood, Colorado, United States
Advanced Neurosciences Research, LLC
Fort Collins, Colorado, United States
Associated Neurologists of Southern Connecticut
Fairfield, Connecticut, United States
Avail Clinical Research LLC
DeLand, Florida, United States
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, United States
|Renstar Medical Research
Ocala, Florida, United States
Psychiatric Inst of Florida-Clinical Neuroscience Solutions
Orlando, Florida, United States
Compass Research
Oviedo, Florida, United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States
Northwest Clinical Trials
Boise, Idaho, United States
Christie Clinic, LLC
Champaign, Illinois, United States
Robbins Headache Clinic
Riverwoods, Illinois, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States
Phoenix Medical Research, Inc
Prairie Village, Kansas, United States
Heartland Research Associates
Wichita, Kansas, United States
PharmaSite Research Inc
Baltimore, Maryland, United States
Boston Clinical Trials Inc
Boston, Massachusetts, United States
Michigan Head, Pain and Neurological Institute
Ann Arbor, Michigan, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
Healthcare Research Network - Hazelwood
Hazelwood, Missouri, United States
ClinVest
Springfield, Missouri, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States
Dent Neurological Institute
Amherst, New York, United States
Island Neuro Associates,PC
Plainview, New York, United States
Univ of Cincinnati College of Medicine
Cincinnati, Ohio, United States
Healthcare Research Consultant
Tulsa, Oklahoma, United States
Preferred Primary Care Physicians
Pleasant Hills, Pennsylvania, United States
Abington Neurological Associates
Willow Grove, Pennsylvania, United States
Clinical Trials of South Carolina
Charleston, South Carolina, United States
University of South Carolina
Columbia, South Carolina, United States
Coastal Carolina Research Center, Inc.
Mt. Pleasant, South Carolina, United States
BG Neurology
Spartanburg, South Carolina, United States
ClinSearch
Chattanooga, Tennessee, United States
FutureSearch Trials of Neurology and Sleep Lab
Austin, Texas, United States
Headache Medicine Specialist of North Texas
Dallas, Texas, United States
Foothill Family Clinic
Salt Lake City, 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
Premier Clinical Research
Spokane, 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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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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Ciudad Autonoma de Buenos Aire, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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Brampton, , Canada
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Kelowna, , Canada
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Montreal, , Canada
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Ottawa, , Canada
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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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Essen, , Germany
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Hamburg, , 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
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Hadera, , Israel
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Kfar Saba, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Bologna, , Italy
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Florence, , Italy
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Modena, , Italy
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Pavia, , Italy
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Roma, , Italy
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Aguascalientes, , Mexico
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Culiacán, , Mexico
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México, , Mexico
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Amsterdam, , Netherlands
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Leiden, , Netherlands
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Nijmegen, , Netherlands
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Zwolle, , Netherlands
Office of Dr. Ruddy Guerra
ManatÃ, , Puerto Rico
GCM Medical Group PSC
San Juan, , Puerto Rico
Instituto de Neurologia Dra. Ivonne Fraga
San Juan, , Puerto Rico
Neuro GI Wellness Center
San Juan, , Puerto Rico
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Barcelona, , Spain
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Barcelona, , Spain
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Pamplona, , 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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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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London, , United Kingdom
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Stoke-on-Trent, , United Kingdom
Countries
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References
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Diener HC, Day KA, Lipsius S, Aurora SK, Hindiyeh NA, Detke HC. Shift from chronic to episodic migraine frequency in a long-term phase 3 study of galcanezumab. J Headache Pain. 2025 Feb 3;26(1):26. doi: 10.1186/s10194-025-01956-x.
Pozo-Rosich P, Detke HC, Wang S, Dolezil D, Li LQ, Aurora SK, Reuter U. Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study. Curr Med Res Opin. 2022 May;38(5):731-742. doi: 10.1080/03007995.2022.2059975. Epub 2022 Apr 15.
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.
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.
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of LY2951742 in the Prevention of Chronic Migraine (REGAIN)
Other Identifiers
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I5Q-MC-CGAI
Identifier Type: OTHER
Identifier Source: secondary_id
2015-001883-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15769
Identifier Type: -
Identifier Source: org_study_id
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