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Is galcanezumab effective for prevention of migraine?
In this randomized clinical trial, administration of galcanezumab, 120 mg, once monthly to patients with a history of migraine who completed treatment significantly reduced the number of migraine headache days compared with placebo, with good tolerability and no emergent safety issues.
Monoclonal antibodies against calcitonin gene-related peptide, such as galcanezumab, represent a novel approach in migraine prevention.
Galcanezumab (LY2951742), a monoclonal antibody against calcitonin gene-related peptide (CGRP), is one of a novel class of new medicines for migraine prevention.
To assess whether at least 1 dose of galcanezumab was superior to placebo for episodic migraine prevention.
Design, Setting, and Participants
A randomized clinical trial was conducted in the United States (July 7, 2014, to August 19, 2015) in clinics of 37 licensed physicians with a specialty including, but not limited to, psychiatry, neurology, internal medicine, and primary care. Subcutaneous injections of galcanezumab, 5, 50, 120, or 300 mg, or placebo were given monthly during the 3-month treatment period. A total of 936 patients were assessed; 526 did not meet study entry or baseline criteria and 410 patients were randomly assigned to receive placebo or galcanezumab. Analyses were conducted on an intent-to-treat population, which included all patients who were randomized and received at least 1 dose of study drug.
Short-term migraine treatments were allowed as needed except for opioids or barbiturates.
Main Outcomes and Measures
To determine if at least 1 of the 4 doses of galcanezumab tested was superior to placebo for migraine prevention measured by the mean change from baseline in the number of migraine headache days 9 weeks to 12 weeks after randomization.
Of the 936 patients assessed, 410 met entry criteria (aged 18-65 years with 4-14 migraine headache days per month and migraine onset prior to age 50 years) and were randomized to receive placebo or galcanezumab.For the primary end point, galcanezumab, 120 mg, significantly reduced migraine headache days compared with placebo (99.6% posterior probability −4.8 days; 90% BCI, −5.4 to −4.2 days vs 95% superiority threshold [Bayesian analysis] −3.7 days; 90% BCI, −4.1 to −3.2 days). Adverse events reported by 5% or more of patients in at least 1 galcanezumab dose group and more frequently than placebo included injection-site pain, upper respiratory tract infection, nasopharyngitis, dysmenorrhea, and nausea.
Conclusions and Relevance
Monthly subcutaneous injections of galcanezumab, both 120 mg and 300 mg, demonstrated efficacy (repeated-measures analysis) for the preventive treatment of migraine and support further development in larger phase 3 studies. All dosages were safe and well tolerated for the preventive treatment of episodic migraine.
clinicaltrials.gov Identifier: NCT02163993
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Corresponding Author: David W. Dodick, MD, Department of Neurology, Mayo Clinic, 13400 E Shea Blvd, Scottsdale, AZ 85259 (firstname.lastname@example.org).
Accepted for Publication: September 21, 2017.
Published Online: December 18, 2017. doi:10.1001/jamaneurol.2017.3859
Open Access: This article is published under the JN-OA license and is free to read on the day of publication.
Correction: This article was corrected on February 12, 2018, to fix errors in the Conflict of Interest Disclosures.
Author Contributions: Drs Skljarevski and Zhang had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Skljarevski, Oakes, Zhang, Ferguson, Johnson, Schacht, Goadsby, Dodick.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Skljarevski, Oakes, Zhang, Ferguson, Johnson, Carter, Goadsby, Dodick.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Zhang, Shan.
Obtained funding: Schacht.
Administrative, technical, or material support: Oakes, Ferguson, Carter, Schacht.
Conflict of Interest Disclosures: Drs Skljarevski, Oakes, Zhang, Ferguson, Martinez, Camporeale, Johnson, Shan, Carter, and Schacht are full-time employees of Eli Lilly and Company and/or one of its subsidiaries, and are stockholders. Dr Goadsby reports receiving consultant fees from Allergan, Amgen, and Eli-Lilly and Company; and personal fees from Akita Biomedical, Alder Biopharmaceuticals, Autonomic Technologies Inc, Avanir Pharma, Cipla Ltd, Colucid Pharmaceuticals, Ltd, Dr Reddy's Laboratories, eNeura, Electrocore LLC, Novartis, Pfizer Inc, Promius Pharma, Quest Diagnostics, Scion, Teva Pharmaceuticals, Trigemina Inc; MedicoLegal work, Journal Watch, UptoDate, and Oxford University Press. In addition, Dr Goadsby has a patent magnetic stimulation for headache pending assigned to eNeura. Dr Dodick has received compensation from serving on advisory boards and/or consulting within the past 5 years for Allergan, Amgen, Alder, Arteaus, Pfizer, Colucid, Merck, NuPathe, Eli Lilly and Company, Autonomic Technologies, Ethicon J&J, Zogenix, Supernus, Labrys, Boston Scientific, Medtronic, St Jude, Bristol-Myers Squibb, Lundbeck, Impax, MAP, Electrocore, Tonix, Novartis, Teva, Alcobra, Zosano, Insys, GBS/Nocira, Acorda, eNeura, Charleston Laboratories, Gore, Biohaven, Bioventric, Magellan, Theranica, Xenon, and Dr Reddy’s/Promius Pharma. Dr Dodick owns equity in Epien, GBS/Nocira, Second Opinion, Healint, and Theranica. Dr Dodick has received funding for travel, speaking, editorial activities, or royalty payments from IntraMed, SAGE Publishing, Sun Pharma, Allergan, Oxford University Press, American Academy of Neurology, American Headache Society, West Virginia University Foundation, Canadian Headache Society, HealthLogix, Universal Meeting Management, WebMD, UptoDate, Medscape, Oregon Health Science Center, Albert Einstein University, University of Toronto, Starr Clinical, Decision Resources, Synergy, MedNet LLC, Peer View Institute for Medical Education, Medicom, Chameleon Communications, Academy for Continued Healthcare Learning, Haymarket Medical Education, Global Scientific Communications, HealthLogix, Miller Medical, MeetingLogiX, and Wiley Blackwell. Dr Dodick, through his employer, has consulting use agreements with NeuroAssessment Systems and Myndshft. He holds board of director positions with King-Devick Technologies and Epien Inc. He holds the following Patent 17189376.1-1466:vTitle: Botulinum Toxin Dosage Regimen for Chronic Migraine Prophylaxis (no compensation). No other disclosures are reported.
Funding/Support: This study was sponsored and funded by Eli Lilly and Company, who also provided the study drug.
Role of the Funder/Sponsor: Eli Lilly and Company designed and conducted the study; managed collection of data, and oversaw any affiliated contracted research organizations in the process of conducting the study. All statistical analyses reported were performed by Eli Lilly and Company. All authors and Eli Lilly and Company prepared, reviewed, and approved the manuscript, and made the decision to submit the manuscript for publication.
Additional Contributions: The authors thank the patients, nurses, and physicians involved in this study.
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