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December 11, 2018; 91 (24) ArticleOpen Access

Galcanezumab in chronic migraine

The randomized, double-blind, placebo-controlled REGAIN study

Holland C. Detke, View ORCID ProfilePeter J. Goadsby, Shufang Wang, Deborah I. Friedman, Katherine J. Selzler, Sheena K. Aurora
First published November 16, 2018, DOI: https://doi.org/10.1212/WNL.0000000000006640
Holland C. Detke
From Eli Lilly and Company, Indianapolis, IN (H.C.D., S.W., K.J.S., S.K.A.); Department of Neurology (P.J.G.), NIHR–Wellcome Trust King's Clinical Research Facility, King's College London, UK; University of California (P.J.G.), San Francisco; and Departments of Neurology and Neurotherapeutics and Ophthalmology, University of Texas Southwestern Medical Center, Dallas.
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Peter J. Goadsby
From Eli Lilly and Company, Indianapolis, IN (H.C.D., S.W., K.J.S., S.K.A.); Department of Neurology (P.J.G.), NIHR–Wellcome Trust King's Clinical Research Facility, King's College London, UK; University of California (P.J.G.), San Francisco; and Departments of Neurology and Neurotherapeutics and Ophthalmology, University of Texas Southwestern Medical Center, Dallas.
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  • ORCID record for Peter J. Goadsby
Shufang Wang
From Eli Lilly and Company, Indianapolis, IN (H.C.D., S.W., K.J.S., S.K.A.); Department of Neurology (P.J.G.), NIHR–Wellcome Trust King's Clinical Research Facility, King's College London, UK; University of California (P.J.G.), San Francisco; and Departments of Neurology and Neurotherapeutics and Ophthalmology, University of Texas Southwestern Medical Center, Dallas.
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Deborah I. Friedman
From Eli Lilly and Company, Indianapolis, IN (H.C.D., S.W., K.J.S., S.K.A.); Department of Neurology (P.J.G.), NIHR–Wellcome Trust King's Clinical Research Facility, King's College London, UK; University of California (P.J.G.), San Francisco; and Departments of Neurology and Neurotherapeutics and Ophthalmology, University of Texas Southwestern Medical Center, Dallas.
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Katherine J. Selzler
From Eli Lilly and Company, Indianapolis, IN (H.C.D., S.W., K.J.S., S.K.A.); Department of Neurology (P.J.G.), NIHR–Wellcome Trust King's Clinical Research Facility, King's College London, UK; University of California (P.J.G.), San Francisco; and Departments of Neurology and Neurotherapeutics and Ophthalmology, University of Texas Southwestern Medical Center, Dallas.
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Sheena K. Aurora
From Eli Lilly and Company, Indianapolis, IN (H.C.D., S.W., K.J.S., S.K.A.); Department of Neurology (P.J.G.), NIHR–Wellcome Trust King's Clinical Research Facility, King's College London, UK; University of California (P.J.G.), San Francisco; and Departments of Neurology and Neurotherapeutics and Ophthalmology, University of Texas Southwestern Medical Center, Dallas.
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Galcanezumab in chronic migraine
The randomized, double-blind, placebo-controlled REGAIN study
Holland C. Detke, Peter J. Goadsby, Shufang Wang, Deborah I. Friedman, Katherine J. Selzler, Sheena K. Aurora
Neurology Dec 2018, 91 (24) e2211-e2221; DOI: 10.1212/WNL.0000000000006640

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Abstract

Objective To evaluate the efficacy and safety of galcanezumab, a humanized monoclonal antibody that selectively binds to calcitonin gene-related peptide, in the preventive treatment of chronic migraine.

Methods A phase 3, randomized, double-blind, placebo-controlled study of LY2951742 in patients with chronic migraine (Evaluation of Galcanezumab in the Prevention of Chronic Migraine [REGAIN]) was a phase 3 study with a 3-month double-blind, placebo-controlled treatment phase and a 9-month open-label extension. Eligible patients 18 to 65 years of age with chronic migraine were randomized 2:1:1 to monthly subcutaneous injections of placebo (n = 558), galcanezumab 120 mg (with a 240-mg loading dose, n = 278), or galcanezumab 240 mg (n = 277). The primary endpoint was the overall mean change from baseline in the number of monthly migraine headache days (MHDs) during the 3-month double-blind treatment phase.

Results Mean number of monthly MHDs at baseline was 19.4 for the total sample. Both galcanezumab dose groups demonstrated greater overall mean reduction in the number of monthly MHDs compared to placebo (placebo −2.7, galcanezumab 120 mg −4.8, galcanezumab 240 mg −4.6) (p < 0.001 for each dose compared to placebo). There were no clinically meaningful differences between galcanezumab doses and placebo on any safety or tolerability outcome except for a higher incidence of treatment-emergent injection-site reaction (p < 0.01), injection-site erythema (p < 0.001), injection-site pruritus (p < 0.01), and sinusitis (p < 0.05) in the galcanezumab 240-mg group relative to placebo.

Conclusions Both doses of galcanezumab were superior to placebo in reducing the number of monthly MHDs. Galcanezumab appears efficacious, safe, and well tolerated for the preventive treatment of chronic migraine.

ClinicalTrials.gov identifier NCT02614261.

Classification of evidence This interventional study provides Class I evidence that galcanezumab is superior to placebo in the reduction of the number of monthly MHDs.

Glossary

ADA=
anti-drug antibodies;
AE=
adverse event;
CM=
chronic migraine;
CGRP=
calcitonin gene-related peptide;
ePRO=
electronic patient-reported outcomes;
ICHD=
International Classification of Headache Disorders, 3rd edition, beta version;
MHD=
migraine headache day;
MIDAS=
Migraine Disability Assessment;
MSQ=
Migraine-Specific Quality of Life Questionnaire;
PGI-S=
Patient Global Impression of Severity of Illness;
REGAIN=
Evaluation of Galcanezumab in the Prevention of Chronic Migraine

Footnotes

  • Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

  • The Article Processing Charge was funded by Eli Lilly and Company.

  • See page 1083

  • Class of Evidence: NPub.org/coe

  • Received February 28, 2018.
  • Accepted in final form August 9, 2018.
  • Copyright © 2018 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

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