Tepper, Stewart J.
Ailani, Jessica
Ford, Janet H. http://orcid.org/0000-0001-7966-7737
Nichols, Russell M.
Li, Lily Q.
Kemmer, Phebe
Hand, Austin L.
Tockhorn-Heidenreich, Antje
Clinical trials referenced in this document:
Documents that mention this clinical trial
Effect of Galcanezumab on Total Pain Burden in Patients Who Had Previously Not Benefited from Migraine Preventive Medication (CONQUER Trial): A Post Hoc Analysis
https://doi.org/10.1007/s12325-022-02233-y
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
https://doi.org/10.1007/s12325-021-01848-x
Effects of Galcanezumab on Health-Related Quality of Life and Disability in Patients with Previous Failure of 2–4 Migraine Preventive Medication Categories: Results from a Phase IIIb Randomized, Placebo-Controlled, Multicenter Clinical Trial (CONQUER)
https://doi.org/10.1007/s40261-021-01115-5
Galcanezumab in Patients with Multiple Previous Migraine Preventive Medication Category Failures: Results from the Open-Label Period of the CONQUER Trial
https://doi.org/10.1007/s12325-021-01911-7
Funding for this research was provided by:
eli lilly and company
Article History
Accepted: 21 November 2021
First Online: 18 January 2022
Change Date: 7 March 2022
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1007/s40261-022-01123-z
Declarations
:
: This study was funded by Eli Lilly and Company.
: SJT received grants for research (no personal compensation) from Allergan, Amgen, Eli Lilly, Lundbeck, Neurolief, Novartis, Satsuma, and Zosano; served as a consultant and/or on advisory boards (honoraria) for Aeon, Align Strategies, Allergan/Abbvie, Alphasights, Amgen, Aperture Venture Partners, Aralez Pharmaceuticals Canada, Axsome Therapeutics, Becker Pharmaceutical Consulting, BioDelivery Sciences International, Biohaven, ClearView Healthcare Partners, CRG, Currax, Decision Resources, DeepBench, Eli Lilly, Equinox, ExpertConnect, GLG, Guidepoint Global, Healthcare Consultancy Group, Health Science Communications, HMP Communications, Impel, Lundbeck, M3 Global Research, Magellan Rx Management, Medicxi, Navigant Consulting, Neurolief, Nordic BioTech, Novartis, Pulmatrix, Reckner Healthcare, Relevale, SAI MedPartners, Satsuma, Slingshot Insights, Spherix Global Insights, Sudler and Hennessey, Synapse Medical Communications, Teva, Theranica, Thought Leader Select, Trinity Partners, XOC, and Zosano; received a salary from Dartmouth-Hitchcock Medical Center, American Headache Society, and Thomas Jefferson University; and received CME honoraria from the American Academy of Neurology, American Headache Society, Cleveland Clinic Foundation, Diamond Headache Clinic, Elsevier, Forefront Collaborative, Hamilton General Hospital, Ontario, Canada, Headache Cooperative of New England, Henry Ford Hospital, Detroit, Inova, Medical Learning Institute Peerview, Medical Education Speakers Network, Miller Medical Communications, North American Center for CME, Physicians’ Education Resource, Rockpointe, ScientiaCME, and WebMD/Medscape. JA has received honoraria for consulting from Amgen, Abbvie, Biohaven, Eli Lilly and Company, Lundbeck, Teva, Impel, Satsuma, Theranica, Axsome, and Vorso; received stock options from CtrlM for consulting; honoraria for speaking engagements from Abbvie, Amgen, Biohaven, Eli Lilly, Lundbeck, and Teva; provided advising and editorial services and received honoraria from <i>Current Pain and Headache Reports</i>, SELF, Neurology Live, and Medscape; and engaged in CME with Avent, Pri-Med, Forefront, Medscape, Clinical Care Options, Academy for Continued Healthcare Learning, Answers in CME , and NeurologyLive. JA’s institution has received funding for clinical trials for her work as a principal investigator from Allergan/Abbvie, Biohaven, Eli Lilly and Company, Satsuma, and Zosano. JHF, RMN, LQL, PK, and AT-H hold stocks, and are employees at Eli Lilly and Company. ALH is an employee at IQVIA.
: The CONQUER (NCT03559257) trial protocol was approved by the institutional review boards of each participating center before initiation of patient enrolment. The study adhered to the Declaration of Helsinki, the International Conference on Harmonization Guidelines for Good Clinical Practice, Council for International Organizations of Medical Sciences, and applicable local regulations.
: All patients provided informed consent before enrollment in the trial.
: The article does not contain any individual person’s data in any form. Therefore, consent for publication was not required.
: Eli Lilly and Company provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the USA and the European Union and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once they are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data-sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, and blank or annotated case report forms, will be provided in a secure data-sharing environment for up to 2 years per proposal. For details on submitting a request, see the instructions provided atExternalRef removed.
: Not applicable.
: ALH contributed to the analysis of the data. SJT, JA, JHF, LQL, PK, ALH, and ATH contributed to interpretation of the data All the authors contributed to the writing, critical revision, and final approval of the manuscript.