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July 30, 2019; 93 (5) ArticleOpen Access

Two randomized migraine studies of galcanezumab

Effects on patient functioning and disability

Janet H. Ford, David W. Ayer, Qi Zhang, Jeffrey N. Carter, Elizabeth Leroux, Vladimir Skljarevski, Sheena K. Aurora, Antje Tockhorn-Heidenreich, Richard B. Lipton
First published July 3, 2019, DOI: https://doi.org/10.1212/WNL.0000000000007856
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Article Information

vol. 93 no. 5 e508-e517
DOI: 
https://doi.org/10.1212/WNL.0000000000007856
PubMed: 
31270220
Published By: 
Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology
Print ISSN: 
0028-3878
Online ISSN: 
1526-632X
History: 
  • Received August 14, 2018
  • Accepted in final form March 14, 2019
  • First Published July 3, 2019.

Article Versions

Copyright & Usage: 
Copyright © 2019 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.

Author Disclosures

    1. Janet H. Ford, PhD,
    2. David W. Ayer, PhD,
    3. Qi Zhang, PhD,
    4. Jeffrey N. Carter, PhD,
    5. Elizabeth Leroux, MD,
    6. Vladimir Skljarevski, MD,
    7. Sheena K. Aurora, MD,
    8. Antje Tockhorn-Heidenreich, MSc and
    9. Richard B. Lipton, MD
  1. Janet H. Ford, PhD,
    2. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. 1) Eli Lilly and Company, Global Health Outcomes Research Scientist, 19 years

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. 1) Employed by Eli Lilly and Company

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. 1) Eli Lilly and Company, stock/stock options as part of employment compensation Stock/Stock Options, Medical Equipment & Materials: 1) Eli Lilly and Company (galcanezumab), stock/stock options as part of employment compensation

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  2. David W. Ayer, PhD,
    3. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. Lilly, Senior Research Scientist, 5 years

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Lilly

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. Lilly, 5 years Stock/Stock Options, Medical Equipment & Materials: Lilly, 5 years

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  3. Qi Zhang, PhD,
    4. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. At the time of writing this manuscript, I am employee of Eli Lilly and company.

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  4. Jeffrey N. Carter, PhD,
    5. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. Eli Lilly and Company, 2016-2018

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. During the years 2016-2018, I was a full-time employee of Eli Lilly and Company.

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. As a full-time employee of Eli Lilly and Company from 2016 to 2018, I purchased and currently own minority share of company common stock.

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  5. Elizabeth Leroux, MD,
    6. Scientific Advisory Boards:

    1. (1) Allergan (2) Novartis (3) Eli Lillly (4) Teva Neuroscience

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. (1) Teva Neuroscience

    Speakers' Bureaus:

    1. (1) Allergan (2) Novartis (3) Eli Lillly

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  6. Vladimir Skljarevski, MD,
    7. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. Full-time employee of Eli Lilly and Company

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Full-time employee of Eli Lilly and Company

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. Minor shareholder of Eli Lilly and Company

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  7. Sheena K. Aurora, MD,
    8. Scientific Advisory Boards:

    1. Full time employee of Lilly

    Gifts:

    1. Travel reimbursed by Lilly

    Funding for travel or speaker honoraria:

    1. Lilly

    Editorial Boards:

    1. NONE

    Patents:

    1. With Lilly

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. Lilly

    Consultancies:

    1. Lilly

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Lilly

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. Lilly

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. Lilly Stock/Stock Options, Medical Equipment & Materials: Lilly

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  8. Antje Tockhorn-Heidenreich, MSc and
    9. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. Eli Lilly and Company, Limited, Senior Research Scientist Global Patient Outcomes and Real-World Evidence, employed since 2010-present

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. Eli Lilly and Company

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  9. Richard B. Lipton, MD
    10. Scientific Advisory Boards:

    1. Allergan, e-Neura, Merck

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. Serves as consultant, advisory board member, or has received honoraria from: American Academy of Neurology, Alder, Allergan, American Headache Society, Amgen, Autonomic Technologies, Avanir, Biohaven, Biovision, Boston Scientific, Dr. Reddy?s, Electrocore, Eli Lilly, eNeura Therapeutics, GlaxoSmithKline, Merck, Pernix, Pfizer, Supernus, Teva, Trigemina, Vector, Vedanta

    Editorial Boards:

    1. Neurology, Editorial Board, 2017-

    Patents:

    1. NONE

    Publishing Royalties:

    1. Wolff's Headache, 8th Edition, Oxford University Press; Informa

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Serves as consultant, advisory board member, or has received honoraria from: American Academy of Neurology, Alder, Allergan, American Headache Society, Amgen, Autonomic Technologies, Avanir, Biohaven, Biovision, Boston Scientific, Dr. Reddy?s, Electrocore, Eli Lilly, eNeura Therapeutics, GlaxoSmithKline, Merck, Pernix, Pfizer, Supernus, Teva, Trigemina, Vector, Vedanta

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Vedanta Research Migraine epidemiology and Progression June 2010 - present Boston Scientific Occipital Nerve Stimulation in Migraine March 2013 - present ElectroCore Vagal Nerve Stimulation for Migraine and Cluster May 2013 Novartis Sleep and Migraine September 2012 - present Allergan Botox in Migraine April 2012 - present Allergan Chronic Migraine Epidemiology and Outcome Study January 2012 - present

    Research Support, Government Entities:

    1. NIH/NIA 2PO1 AG003949 Einstein Aging Study 9/1/16-5/31/21 Role: Principle Investigator NIH R01AG042595 Stress, cognition, repetitive unconstructive thoughts and inflammatory markers 7/1/12-6/30/17 Role: Investigator NIH/NINDS 1U10NS077308-01 Einstein Center for Excellence for Clinical Trials in Neuroscience 9/30/11-8/31/18 Role: Co-PI NIH/NINDS R01 NS082432-03 Brain injury due to soccer heading and opportunities for its mitigation 4/1/13-3/31/18 Role: Investigator NINDS/NIH 1R01AG048642 Study of Latinos-Investigation of Neurocognitive Aging 9/1/15-4/30/17 Role: Co-Investigator 1K23NS096107-01 Clinical Decision Support for Patient Migraine Management 4/01/16-3/31/21 Role: Primary Mentor 1K23AG049466-01 The relation of migraine to daily hormone patterns and menopausal stage 9/30/16-5/31/17 Role: Primary Mentor 1K01AG054700-01 Application of latent and integrative approaches to understand the spectrum of cognitive aging 3/15/17-2/28/22 Role: Primary Mentor

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. S & L Marx Foundation Alzheimer's Research Czap Foundation Alzheimer's Research

    Stock/Stock Options/Board of Directors Compensation:

    1. eNeura Pharma; Biohaven Inc.

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. Oxford University Press; Baxter Publishing

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  1. From Eli Lilly and Company (J.H.F., D.W.A., V.S., S.K.A., A.T.-H.), Indianapolis, IN; Sanofi (Q.Z.), Bridgewater, NJ; Elanco (J.N.C.), Greenfield, IN; Department of Neurology (E.L.), University of Calgary, Canada; and Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY.
  1. Correspondence
    Dr. Ford ford_janet{at}lilly.com
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