TY - JOUR
T1 - Galcanezumab in chronic migraine
T2 - The randomized, double-blind, placebo-controlled REGAIN study
AU - Detke, Holland C.
AU - Goadsby, Peter J.
AU - Wang, Shufang
AU - Friedman, Deborah I.
AU - Selzler, Katherine J.
AU - Aurora, Sheena K.
N1 - Funding Information:
H. Detke is a full-time employee and minor shareholder of Eli Lilly and Company. P. Goadsby reports grants from Eli Lilly and Company; personal fees from Alder BioPharmaceuticals, Dr Reddy’s Laboratories, Electrocore LLC, Novartis, Pfizer Inc, Scion, Teva Pharmaceuticals, medicolegal work, Journal Watch, Up-to-Date, Oxford University Press, Massachusetts Medical Society, and Wolters Kluwer; grants and personal fees from Allergan, Amgen, and eNeura Inc; and other from Trigemina Inc. In addition, Dr. Goadsby has a patent for magnetic stimulation for headache licensed to eNeura without fee. S. Wang is a full-time employee and minor shareholder of Eli Lilly and Company. D. Friedman reports speaker fees from Allergan; advisory board and speaker fees from Supernus and Amgen; advisory board, consultant, and speaker fees from Avanir; advisory board fees from Alder BioPharmaceuticals and Biohaven Pharmaceuticals; consultant and advisory board fees from electroCore; advisory board and grant support from Teva and Zosano; grant support and consultant fees from Eli Lilly and Company; and grant support from Merck, Autonomic Technologies, Inc, and Axon Optics. D. Friedman has been a consultant for Promius, serves on editorial board for Neurology Reviews, and is a contributing author to MedLink Neurology. K. Selzler and S. Aurora are full-time employees and minor shareholders of Eli Lilly and Company. Go to Neurology.org/N for full disclosures.
Funding Information:
Study was funded by Eli Lilly and Company. This work has been reported previously at the American Headache Society and International Headache Society meetings in 2017.
Publisher Copyright:
Copyright © 2018 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.
PY - 2018
Y1 - 2018
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85058611353&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85058611353&partnerID=8YFLogxK
U2 - 10.1212/WNL.0000000000006640
DO - 10.1212/WNL.0000000000006640
M3 - Article
C2 - 30446596
AN - SCOPUS:85058611353
VL - 91
SP - E2211-E2221
JO - Neurology
JF - Neurology
SN - 0028-3878
IS - 24
ER -