Evaluation of Galcanezumab in the Prevention of Chronic Migraine
REGAIN
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Chronic Migraine - the REGAIN Study
3 other identifiers
interventional
1,117
13 countries
117
Brief Summary
The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic 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
Longer than P75 for phase_3
117 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 16, 2017
CompletedResults Posted
Study results publicly available
January 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 14, 2021
CompletedMay 18, 2022
April 1, 2022
1.3 years
November 23, 2015
October 19, 2018
April 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHD)
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 3 from mixed model repeated measures (MMRM) model. Least square(LS) Mean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.
Baseline, Month 1 through Month 3
Secondary Outcomes (10)
Number of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
Baseline, Month 1 through Month 3
Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Role-function Restrictive Domain
Baseline, Month 3
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 3
Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score
Baseline, Month 3
Overall Mean Change From Baseline in Headache Hours
Baseline, Month 1 through Month 3
- +5 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATOR* 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 120 mg
EXPERIMENTAL* 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 240 mg
EXPERIMENTAL* 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.
Israel Addendum
EXPERIMENTALEligible 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.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- Main Study:
- 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.
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 (117)
21st Century Neurology
Phoenix, Arizona, 85004, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Pharmacology Research Institute, Encino
Encino, California, 91316, United States
Fullerton Neurology and Headache Center
Fullerton, California, 92835, United States
Pharmacology Research Institute, Los Alamitos
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
Optimus Medical Group
San Francisco, California, 94102, United States
Colorado Neurological Institute
Englewood, Colorado, 80113, United States
Advanced Neurosciences Research, LLC
Fort Collins, Colorado, 80528, United States
Associated Neurologists of Southern Connecticut
Fairfield, Connecticut, 06824, United States
Avail Clinical Research LLC
DeLand, Florida, 32720, United States
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, 32256, United States
|Renstar Medical Research
Ocala, Florida, 34471, United States
Psychiatric Inst of Florida-Clinical Neuroscience Solutions
Orlando, Florida, 32801, United States
Compass Research
Oviedo, Florida, 32765, United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407, United States
Northwest Clinical Trials
Boise, Idaho, 83704, United States
Christie Clinic, LLC
Champaign, Illinois, 61820, United States
Robbins Headache Clinic
Riverwoods, Illinois, 60015, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, 46260, United States
Phoenix Medical Research, Inc
Prairie Village, Kansas, 66208, United States
Heartland Research Associates
Wichita, Kansas, 67205, 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
Healthcare Research Network - Hazelwood
Hazelwood, Missouri, 63042, United States
ClinVest
Springfield, Missouri, 65807, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102, United States
Dent Neurological Institute
Amherst, New York, 14226, United States
Island Neuro Associates,PC
Plainview, New York, 11803, United States
Univ of Cincinnati College of Medicine
Cincinnati, Ohio, 45219, United States
Healthcare Research Consultant
Tulsa, Oklahoma, 74135, United States
Preferred Primary Care Physicians
Pleasant Hills, Pennsylvania, 15236, United States
Abington Neurological Associates
Willow Grove, Pennsylvania, 19090, United States
Clinical Trials of South Carolina
Charleston, South Carolina, 29406, United States
University of South Carolina
Columbia, South Carolina, 29203, United States
Coastal Carolina Research Center, Inc.
Mt. Pleasant, South Carolina, 29464, United States
BG Neurology
Spartanburg, South Carolina, 29307, United States
ClinSearch
Chattanooga, Tennessee, 37421, United States
FutureSearch Trials of Neurology and Sleep Lab
Austin, Texas, 78731, United States
Headache Medicine Specialist of North Texas
Dallas, Texas, 75231, United States
Foothill Family Clinic
Salt Lake City, Utah, 84109, 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
Premier Clinical Research
Spokane, Washington, 99202, 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, C1056ABJ, 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, C1046AAQ, Argentina
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Ciudad Autonoma de Buenos Aire, C1128AAF, Argentina
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Ciudad Autonoma de Buenos Aire, C1204AAD, Argentina
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Ciudad Autonoma de Buenos Aire, C1428AQK, Argentina
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Ciudad Autonoma de Buenos Aire, C1430EGF, Argentina
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CĂ³rdoba, X5000EDC, Argentina
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CĂ³rdoba, X5021FPQ, Argentina
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Brampton, L6T 0G1, Canada
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Kelowna, V1Y 1Z9, Canada
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Montreal, H3A 2B4, Canada
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Ottawa, K2G 6E2, Canada
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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, 1790 12, 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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Essen, 45147, Germany
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Hamburg, 20246, 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
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Hadera, 38100, Israel
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Kfar Saba, 4420122, Israel
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Ramat Gan, 5266202, Israel
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Tel Aviv, 6423906, Israel
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Bologna, 40139, Italy
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Florence, 50134, Italy
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Modena, 40124, Italy
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Pavia, 27100, Italy
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Roma, 00163, Italy
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Aguascalientes, 20217, Mexico
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CuliacĂ¡n, 80020, Mexico
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MĂ©xico, 03310, Mexico
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Amsterdam, 1078 VV, Netherlands
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Leiden, 2333 ZA, Netherlands
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Nijmegen, 6532 SZ, Netherlands
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Zwolle, 8025 AB, Netherlands
Office of Dr. Ruddy Guerra
ManatĂ, 00674, 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
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Barcelona, 08028, Spain
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Barcelona, 08035, Spain
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Pamplona, 31008, 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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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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London, SE5 9RS, United Kingdom
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Stoke-on-Trent, ST4 6QG, United Kingdom
Related Publications (17)
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.
PMID: 39901101DERIVEDPozo-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.
PMID: 35392739DERIVEDAilani 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: 34264500DERIVEDPozo-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.
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PMID: 30446596DERIVED
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 16, 2017
Study Completion
July 14, 2021
Last Updated
May 18, 2022
Results First Posted
January 7, 2019
Record last verified: 2022-04
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.