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August 2019; 9 (4) ReviewOpen Access

Consensus-based care recommendations for adults with myotonic dystrophy type 2

Benedikt Schoser, Federica Montagnese, Guillaume Bassez, Barbara Fossati, Josep Gamez, Chad Heatwole, James Hilbert, Cornelia Kornblum, Anne Kostera-Pruszczyk, Ralf Krahe, Anna Lusakowska, Giovanni Meola, Richard Moxley, Charles Thornton, Bjarne Udd, Paul Formaker, on behalf of the Myotonic Dystrophy Foundation
First published April 24, 2019, DOI: https://doi.org/10.1212/CPJ.0000000000000645
Benedikt Schoser
Ludwig-Maximilians- Universität (BS); Friedrich-Baur-Institut (FM), Munich, Germany; Institut de Myologie (GB), Paris, France; U.O. Neurologia (BF), IRCCS Policlinico San Donato, Milan, Italy; Vall d'Hebron University Hospital (JG), Barcelona, Spain; University of Rochester (CH, JH, RM, CT), Rochester, NY; University Hospital of Bonn (CK), Germany; Medical University of Warsaw (AK-P), Poland; University of Texas (RK) MD Anderson cancer center; Medical University of Warsaw (AL), Poland; Department of Biomedical Sciences for health (GM), University of Milan, Italy; Tampere University (BU), Finland; Myotonic Dystrophy Foundation (PF), San Francisco.
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Federica Montagnese
Ludwig-Maximilians- Universität (BS); Friedrich-Baur-Institut (FM), Munich, Germany; Institut de Myologie (GB), Paris, France; U.O. Neurologia (BF), IRCCS Policlinico San Donato, Milan, Italy; Vall d'Hebron University Hospital (JG), Barcelona, Spain; University of Rochester (CH, JH, RM, CT), Rochester, NY; University Hospital of Bonn (CK), Germany; Medical University of Warsaw (AK-P), Poland; University of Texas (RK) MD Anderson cancer center; Medical University of Warsaw (AL), Poland; Department of Biomedical Sciences for health (GM), University of Milan, Italy; Tampere University (BU), Finland; Myotonic Dystrophy Foundation (PF), San Francisco.
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Guillaume Bassez
Ludwig-Maximilians- Universität (BS); Friedrich-Baur-Institut (FM), Munich, Germany; Institut de Myologie (GB), Paris, France; U.O. Neurologia (BF), IRCCS Policlinico San Donato, Milan, Italy; Vall d'Hebron University Hospital (JG), Barcelona, Spain; University of Rochester (CH, JH, RM, CT), Rochester, NY; University Hospital of Bonn (CK), Germany; Medical University of Warsaw (AK-P), Poland; University of Texas (RK) MD Anderson cancer center; Medical University of Warsaw (AL), Poland; Department of Biomedical Sciences for health (GM), University of Milan, Italy; Tampere University (BU), Finland; Myotonic Dystrophy Foundation (PF), San Francisco.
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Barbara Fossati
Ludwig-Maximilians- Universität (BS); Friedrich-Baur-Institut (FM), Munich, Germany; Institut de Myologie (GB), Paris, France; U.O. Neurologia (BF), IRCCS Policlinico San Donato, Milan, Italy; Vall d'Hebron University Hospital (JG), Barcelona, Spain; University of Rochester (CH, JH, RM, CT), Rochester, NY; University Hospital of Bonn (CK), Germany; Medical University of Warsaw (AK-P), Poland; University of Texas (RK) MD Anderson cancer center; Medical University of Warsaw (AL), Poland; Department of Biomedical Sciences for health (GM), University of Milan, Italy; Tampere University (BU), Finland; Myotonic Dystrophy Foundation (PF), San Francisco.
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Josep Gamez
Ludwig-Maximilians- Universität (BS); Friedrich-Baur-Institut (FM), Munich, Germany; Institut de Myologie (GB), Paris, France; U.O. Neurologia (BF), IRCCS Policlinico San Donato, Milan, Italy; Vall d'Hebron University Hospital (JG), Barcelona, Spain; University of Rochester (CH, JH, RM, CT), Rochester, NY; University Hospital of Bonn (CK), Germany; Medical University of Warsaw (AK-P), Poland; University of Texas (RK) MD Anderson cancer center; Medical University of Warsaw (AL), Poland; Department of Biomedical Sciences for health (GM), University of Milan, Italy; Tampere University (BU), Finland; Myotonic Dystrophy Foundation (PF), San Francisco.
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Chad Heatwole
Ludwig-Maximilians- Universität (BS); Friedrich-Baur-Institut (FM), Munich, Germany; Institut de Myologie (GB), Paris, France; U.O. Neurologia (BF), IRCCS Policlinico San Donato, Milan, Italy; Vall d'Hebron University Hospital (JG), Barcelona, Spain; University of Rochester (CH, JH, RM, CT), Rochester, NY; University Hospital of Bonn (CK), Germany; Medical University of Warsaw (AK-P), Poland; University of Texas (RK) MD Anderson cancer center; Medical University of Warsaw (AL), Poland; Department of Biomedical Sciences for health (GM), University of Milan, Italy; Tampere University (BU), Finland; Myotonic Dystrophy Foundation (PF), San Francisco.
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James Hilbert
Ludwig-Maximilians- Universität (BS); Friedrich-Baur-Institut (FM), Munich, Germany; Institut de Myologie (GB), Paris, France; U.O. Neurologia (BF), IRCCS Policlinico San Donato, Milan, Italy; Vall d'Hebron University Hospital (JG), Barcelona, Spain; University of Rochester (CH, JH, RM, CT), Rochester, NY; University Hospital of Bonn (CK), Germany; Medical University of Warsaw (AK-P), Poland; University of Texas (RK) MD Anderson cancer center; Medical University of Warsaw (AL), Poland; Department of Biomedical Sciences for health (GM), University of Milan, Italy; Tampere University (BU), Finland; Myotonic Dystrophy Foundation (PF), San Francisco.
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Cornelia Kornblum
Ludwig-Maximilians- Universität (BS); Friedrich-Baur-Institut (FM), Munich, Germany; Institut de Myologie (GB), Paris, France; U.O. Neurologia (BF), IRCCS Policlinico San Donato, Milan, Italy; Vall d'Hebron University Hospital (JG), Barcelona, Spain; University of Rochester (CH, JH, RM, CT), Rochester, NY; University Hospital of Bonn (CK), Germany; Medical University of Warsaw (AK-P), Poland; University of Texas (RK) MD Anderson cancer center; Medical University of Warsaw (AL), Poland; Department of Biomedical Sciences for health (GM), University of Milan, Italy; Tampere University (BU), Finland; Myotonic Dystrophy Foundation (PF), San Francisco.
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Anne Kostera-Pruszczyk
Ludwig-Maximilians- Universität (BS); Friedrich-Baur-Institut (FM), Munich, Germany; Institut de Myologie (GB), Paris, France; U.O. Neurologia (BF), IRCCS Policlinico San Donato, Milan, Italy; Vall d'Hebron University Hospital (JG), Barcelona, Spain; University of Rochester (CH, JH, RM, CT), Rochester, NY; University Hospital of Bonn (CK), Germany; Medical University of Warsaw (AK-P), Poland; University of Texas (RK) MD Anderson cancer center; Medical University of Warsaw (AL), Poland; Department of Biomedical Sciences for health (GM), University of Milan, Italy; Tampere University (BU), Finland; Myotonic Dystrophy Foundation (PF), San Francisco.
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Ralf Krahe
Ludwig-Maximilians- Universität (BS); Friedrich-Baur-Institut (FM), Munich, Germany; Institut de Myologie (GB), Paris, France; U.O. Neurologia (BF), IRCCS Policlinico San Donato, Milan, Italy; Vall d'Hebron University Hospital (JG), Barcelona, Spain; University of Rochester (CH, JH, RM, CT), Rochester, NY; University Hospital of Bonn (CK), Germany; Medical University of Warsaw (AK-P), Poland; University of Texas (RK) MD Anderson cancer center; Medical University of Warsaw (AL), Poland; Department of Biomedical Sciences for health (GM), University of Milan, Italy; Tampere University (BU), Finland; Myotonic Dystrophy Foundation (PF), San Francisco.
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Anna Lusakowska
Ludwig-Maximilians- Universität (BS); Friedrich-Baur-Institut (FM), Munich, Germany; Institut de Myologie (GB), Paris, France; U.O. Neurologia (BF), IRCCS Policlinico San Donato, Milan, Italy; Vall d'Hebron University Hospital (JG), Barcelona, Spain; University of Rochester (CH, JH, RM, CT), Rochester, NY; University Hospital of Bonn (CK), Germany; Medical University of Warsaw (AK-P), Poland; University of Texas (RK) MD Anderson cancer center; Medical University of Warsaw (AL), Poland; Department of Biomedical Sciences for health (GM), University of Milan, Italy; Tampere University (BU), Finland; Myotonic Dystrophy Foundation (PF), San Francisco.
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Giovanni Meola
Ludwig-Maximilians- Universität (BS); Friedrich-Baur-Institut (FM), Munich, Germany; Institut de Myologie (GB), Paris, France; U.O. Neurologia (BF), IRCCS Policlinico San Donato, Milan, Italy; Vall d'Hebron University Hospital (JG), Barcelona, Spain; University of Rochester (CH, JH, RM, CT), Rochester, NY; University Hospital of Bonn (CK), Germany; Medical University of Warsaw (AK-P), Poland; University of Texas (RK) MD Anderson cancer center; Medical University of Warsaw (AL), Poland; Department of Biomedical Sciences for health (GM), University of Milan, Italy; Tampere University (BU), Finland; Myotonic Dystrophy Foundation (PF), San Francisco.
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Richard Moxley III
Ludwig-Maximilians- Universität (BS); Friedrich-Baur-Institut (FM), Munich, Germany; Institut de Myologie (GB), Paris, France; U.O. Neurologia (BF), IRCCS Policlinico San Donato, Milan, Italy; Vall d'Hebron University Hospital (JG), Barcelona, Spain; University of Rochester (CH, JH, RM, CT), Rochester, NY; University Hospital of Bonn (CK), Germany; Medical University of Warsaw (AK-P), Poland; University of Texas (RK) MD Anderson cancer center; Medical University of Warsaw (AL), Poland; Department of Biomedical Sciences for health (GM), University of Milan, Italy; Tampere University (BU), Finland; Myotonic Dystrophy Foundation (PF), San Francisco.
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Charles Thornton
Ludwig-Maximilians- Universität (BS); Friedrich-Baur-Institut (FM), Munich, Germany; Institut de Myologie (GB), Paris, France; U.O. Neurologia (BF), IRCCS Policlinico San Donato, Milan, Italy; Vall d'Hebron University Hospital (JG), Barcelona, Spain; University of Rochester (CH, JH, RM, CT), Rochester, NY; University Hospital of Bonn (CK), Germany; Medical University of Warsaw (AK-P), Poland; University of Texas (RK) MD Anderson cancer center; Medical University of Warsaw (AL), Poland; Department of Biomedical Sciences for health (GM), University of Milan, Italy; Tampere University (BU), Finland; Myotonic Dystrophy Foundation (PF), San Francisco.
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Bjarne Udd
Ludwig-Maximilians- Universität (BS); Friedrich-Baur-Institut (FM), Munich, Germany; Institut de Myologie (GB), Paris, France; U.O. Neurologia (BF), IRCCS Policlinico San Donato, Milan, Italy; Vall d'Hebron University Hospital (JG), Barcelona, Spain; University of Rochester (CH, JH, RM, CT), Rochester, NY; University Hospital of Bonn (CK), Germany; Medical University of Warsaw (AK-P), Poland; University of Texas (RK) MD Anderson cancer center; Medical University of Warsaw (AL), Poland; Department of Biomedical Sciences for health (GM), University of Milan, Italy; Tampere University (BU), Finland; Myotonic Dystrophy Foundation (PF), San Francisco.
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Paul Formaker
Ludwig-Maximilians- Universität (BS); Friedrich-Baur-Institut (FM), Munich, Germany; Institut de Myologie (GB), Paris, France; U.O. Neurologia (BF), IRCCS Policlinico San Donato, Milan, Italy; Vall d'Hebron University Hospital (JG), Barcelona, Spain; University of Rochester (CH, JH, RM, CT), Rochester, NY; University Hospital of Bonn (CK), Germany; Medical University of Warsaw (AK-P), Poland; University of Texas (RK) MD Anderson cancer center; Medical University of Warsaw (AL), Poland; Department of Biomedical Sciences for health (GM), University of Milan, Italy; Tampere University (BU), Finland; Myotonic Dystrophy Foundation (PF), San Francisco.
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Ludwig-Maximilians- Universität (BS); Friedrich-Baur-Institut (FM), Munich, Germany; Institut de Myologie (GB), Paris, France; U.O. Neurologia (BF), IRCCS Policlinico San Donato, Milan, Italy; Vall d'Hebron University Hospital (JG), Barcelona, Spain; University of Rochester (CH, JH, RM, CT), Rochester, NY; University Hospital of Bonn (CK), Germany; Medical University of Warsaw (AK-P), Poland; University of Texas (RK) MD Anderson cancer center; Medical University of Warsaw (AL), Poland; Department of Biomedical Sciences for health (GM), University of Milan, Italy; Tampere University (BU), Finland; Myotonic Dystrophy Foundation (PF), San Francisco.
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Consensus-based care recommendations for adults with myotonic dystrophy type 2
Benedikt Schoser, Federica Montagnese, Guillaume Bassez, Barbara Fossati, Josep Gamez, Chad Heatwole, James Hilbert, Cornelia Kornblum, Anne Kostera-Pruszczyk, Ralf Krahe, Anna Lusakowska, Giovanni Meola, Richard Moxley, Charles Thornton, Bjarne Udd, Paul Formaker, on behalf of the Myotonic Dystrophy Foundation
Neurol Clin Pract Aug 2019, 9 (4) 343-353; DOI: 10.1212/CPJ.0000000000000645

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Article Information

vol. 9 no. 4 343-353
DOI: 
https://doi.org/10.1212/CPJ.0000000000000645

Published By: 
Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology
Print ISSN: 
2163-0402
Online ISSN: 
2163-0933
History: 
  • Received December 10, 2018
  • Accepted February 18, 2019
  • First Published April 24, 2019.

Article Versions

  • Previous version (April 24, 2019 - 12:45).
  • You are viewing the most recent version of this article.
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. Benedikt Schoser, MD,
    2. Federica Montagnese, MD,
    3. Guillaume Bassez, MD, PhD,
    4. Barbara Fossati, MD,
    5. Josep Gamez, MD, PhD,
    6. Chad Heatwole, MD,
    7. James Hilbert, MS,
    8. Cornelia Kornblum, MD,
    9. Anne Kostera-Pruszczyk, MD, PhD,
    10. Ralf Krahe, PhD,
    11. Anna Lusakowska, MD, PhD,
    12. Giovanni Meola, MD,
    13. Richard Moxley III, MD,
    14. Charles Thornton, MD,
    15. Bjarne Udd, MD, PhD,
    16. Paul Formaker,
    17. on behalf of the Myotonic Dystrophy Foundation
  1. Benedikt Schoser, MD,
  2. Scientific Advisory Boards:
    1. (1) Sanofi-Genzyme Global Pompe advisory board (1) Biomarin Pharmaceutica Global Pompe advisory board (1) Amicus Therapeutics Global advisory board (1) Audentes Therapeutics Global neuromsuclar advisory board (1) Nexien Biopharm Scientific advisor (1) Lupin therapeutics Global advisory board

    Gifts:
    1. NONE

    Funding for travel or speaker honoraria:
    1. (1) Sanofi-Genzyme Global Pompe advisory board: travel support (1) Biomarin Pharmaceutica Global Pompe advisory board: travel support (1) Amicus Therapeutics Global advisory board: travel support (1) Audentes Therapeutics Global neuromsuclar advisory board: travel support (1) Lupin therapeutics Global advisory board: travel support

    Editorial Boards:
    1. Editorial advisory board member: Neuromuscular disorders (no compensation) Journal of Neuromuscular disorders (no compensation) Section editor: Current opinion in Neurology (no compensation)

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    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

  3. Federica Montagnese, MD,
  4. Scientific Advisory Boards:
    1. Served on a scientific advisory board organized by Lupin Europe GmbH for the approval of mexiletin for the treatment of myotonia.

    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. 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

  5. Guillaume Bassez, MD, PhD,
  6. Scientific Advisory Boards:
    1. (1) Lupin pharmaceuticals, scientific advisory board, commercial entity (2) AFM-Telethon, scientific advisory board, non-profit entity (3) Myotonic Dystrophy Fondation, scientific advisory board, non-profit entity

    Gifts:
    1. NONE

    Funding for travel or speaker honoraria:
    1. (1) Myotonic Dystrophy Fondation, non-profit entity, travel (2) Sanofi-Genzyme, commercial, travel

    Editorial Boards:
    1. NONE

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. (1) Lupin pharmaceuticals, commercial entity, consulting honoraria

    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. FP7 EU grant- Optimistic study

    Research Support, Foundations and Societies:
    1. AFM-Telethon Foundation grant-Myotonic dystrophy registry

    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

  7. Barbara Fossati, MD,
  8. 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. NONE

    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

  9. Josep Gamez, MD, PhD,
  10. 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. NONE

    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

  11. Chad Heatwole, MD,
  12. Scientific Advisory Boards:
    1. Biogen: Functional Outcome Measures for Teen and Adult Patients with SMA Advisory Board.

    Gifts:
    1. NONE

    Funding for travel or speaker honoraria:
    1. Myotonic Dystrophy Foundation: Funded airfare for research project in Italy.

    Editorial Boards:
    1. NONE

    Patents:
    1. NONE

    Publishing Royalties:
    1. I have recieved royalties for the use of the Myotonic Dystrophy Health Index (MDHI) a disease-specific patient reported outcome measure for use in clinical trials. I have also received royalties from the licensing of my instruments for FSHD, congenital DM1, CMT, SMA, and Huntington's disease.

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. Consultant to Imedecs, Maximus, Johns Hopkins University, Biogen, Atyr, Ionis, Acceleron, Cytokinetics, ExpansionRX, AMO, and the Marigold foundation.

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. Pfizer provided study drug (rHGH) for a RO1 funded study.

    Research Support, Government Entities:
    1. National Institutes of Health (NINDS) STARFiSH: Study of Testosterone and rHGH in FSHD: A Proof- of-Concept Study 2017-2021 PI National Institutes of Health Paul Wellstone Muscular Dystrophy Cooperative Research Center Umbrella Center (MDCRC) U54NS048843 September 2013 ? present Co-Investigator United States Food and Drug Administration Mexiletine Treatment in Myotonic Dystrophy Type-1 R01FD003716 June 2011 ? 2017 PI

    Research Support, Academic Entities:
    1. Technology Development Fund (University of Rochester) Development of a Disease-specific instrument for Lung Cancer 2018-2020 University of Rochester PI Technology Development Fund (University of Rochester) Development of a Disease-specific instrument for Crohn?s Disease University of Rochester 2017-2018 PI

    Research Support, Foundations and Societies:
    1. Development of Disease-Specific Patient Reported Outcome Measures for Duchenne Muscular Dystrophy Therapeutic Trials Muscular Dystrophy Association 2018-2020 PI Cure Spinal Muscular Atrophy 1/15/2018-1/15/2020 PI Amyotrophic Lateral Sclerosis Association Development of a Clinically Relevant Outcome Measure for ALS Therapeutic Trials 1/1/18- 12/31/20 PI Huntington Study Group/ NJ Cure HD Foundation Development of the Huntington Disease Health Index. 2017-2019 PI Cure SMA Development of a Clinically Relevant Outcome Measure for SMA Therapeutic Trials June 2015- June 2018 PI Clinically Relevant Disease Specific Patient Reported Outcome Measures for use in Friedreich?s Ataxia Therapeutic Trials and FDA Drug Labeling Claims Friedreich?s Ataxia Research Alliance (FARA) 2018-2020 PI

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License fee payments, Technology or Inventions:
    1. I have recieved license fee payments for the Myotonic Dystrophy Health Index (MDHI) and other disease-specific PROs through the University of Rochester

    Royalty Payments, Technology or Inventions:
    1. Inventor and author of the Myotonic Dystrophy Health Index (MDHI) and FSHD Health Index (FSHDHI). I have also received royalties from the licensing of my instruments for congenital DM1, CMT, SMA, and Huntington's disease. Future royalties may be obtained from my instruments related to DM2, crohn's disease, ALS, pediatric SMA, and lung cancer.

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. 1) Legal Med, Independent Medical Examinations. 2017 to present. 2) Barclay Damon, Independent Medical Examination. 2017 to present. 3) Matis Baum O'Connor; Record review. 2017.

  13. James Hilbert, MS,
  14. 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. NONE

    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. 1.) NIH, #P50NS048843, Study Coordinator, 2010-2019.

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. Abrams Family Fund, Cure SMA, Friends of FSH Research, FSH Society, and Saunders Family Foundation

    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

  15. Cornelia Kornblum, MD,
  16. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for travel or speaker honoraria:
    1. (1) Commercial company: Sanofi-Genzyme, travel funding (2) Commercial company: Sanofi-Genzyme, speaker honoraria (3) Commercial company: Santhera, speaker honoraria (4) Commercial company: Novartis, speaker honoraria (5) Commercial company: Novartis, travel funding (6) Commercial company: Stealth BioTherapeutics, travel funding (7) Non-profit organisation: Deutsche Gesellschaft f?r Muskelkranke e.V., travel funding (8) Non-profit organisation: Marigold Foundation, Canada, travel funding

    Editorial Boards:
    1. NONE

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. (1) Commercial company: Stealth BioTherapeutics, honoraria for clinical advisory board activity (two meetings, 10/2016-02/2017)

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. (1) Stealth Biotherapeutics, Principal Investigator SPIMM- 300 and SPIMM-301

    Research Support, Government Entities:
    1. (1) BMBF (German Federal Ministry of Education and Research), mitoNET, BMBF - 01GM0862, patient recruitment, 2010 - 2015

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. (1) Non-profit organisation: Marigold Foundation, Canada (2) Non-profit-organisation: Deutsche Gesellschaft f?r Muskelkranke e.V., grant number Me4/1, since 2014

    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

  17. Anne Kostera-Pruszczyk, MD, PhD,
  18. Scientific Advisory Boards:
    1. Scientific Advisory Board for Biogen, PTC, Sarepta, Shire

    Gifts:
    1. NONE

    Funding for travel or speaker honoraria:
    1. personal compensation from Kedrion, Baxter/Shire, CSL Behring, Sanofi Aventis

    Editorial Boards:
    1. Neurology, Neurosurgery and Psychiatry Journal

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    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

  19. Ralf Krahe, PhD,
  20. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. PLOS ONE, academic editor, 5 yrs

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    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

  21. Anna Lusakowska, MD, PhD,
  22. 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. NONE

    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

  23. Giovanni Meola, MD,
  24. 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. NONE

    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

  25. Richard Moxley III, MD,
  26. Scientific Advisory Boards:
    1. 1)NIH/NINDS Steering Committee for Common Data Elements 2)NIH/NINDS Committee on the Development of Neuromuscular Common Data Elements 3)NIH Sub-Committee on Myotonic Dystrophy for Common Data Elements 4) Data Safety Monitoring Board for active studies of CINRG 5) Scientific Advisory Board for Myotonic Dystrophy Foundation

    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. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. Ionis Pharmaceuticals, site PI, 2014-2016

    Research Support, Government Entities:
    1. (1) NIH, U54NS48843, PI, 10/1/03-8/30/18 (2) NCRR/NIH, 1UL 1RR02416002, Co-Dir., 10/1/06-9/30/16 (3) NIH, N01-AR-5-2274, PI, 9/30/05-9/29/10 (4) NIH/NCI, HHSN2612012003188P, PI, 9/01/2012-06/30/2015 (5) NIH, 1 R13 NS093860-01, PI, 6/1/15-5/31/16 (6) FDA, R01 FD003716-04, PI, 06/05/2006-05/31/2017

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. The Saunders Family Foundation The Abrams Family Fund

    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

  27. Charles Thornton, MD,
  28. Scientific Advisory Boards:
    1. (1) NIH data safety monitoring board (2) Scientific Advisory Board of the Myotonic Dystrophy Foundation (3) Dyne, Scientific Advisory Board

    Gifts:
    1. NONE

    Funding for travel or speaker honoraria:
    1. University of Florida, funding for travel; University of Michigan, funding for travel; American Association of Neurololgy, funding for travel; Muscular Dystrophy Association, funding for travel; Myotonic Dystrophy Foundation, funding for travel; World Muscle Society, funding for travel; Fulcrum Therapeutics, funding for travel, Dyne Therapeutics, funding for travel; Lion Therapeutics, funding for travel; Nature Conferences, funding for travel

    Editorial Boards:
    1. NONE

    Patents:
    1. (1) Modulation of Dystrophia Myotonica-Protein Kinase (DMPK) Expression (2) Compositions and Methods Related to Protein Displacement Therapy for Myotonic Dystrophy (3) Methods and Compositions for Treatment of Diseases Associated with Aberrant Microsatellite Expansion

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. (1) Isis Pharmaceuticals, consultant (2) Biogen Inc., consultant

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. (1) Sponsored research support from from Isis Pharmaceuticals (2) Sponsored research support from Biogen Inc.

    Research Support, Government Entities:
    1. NIH NS48843, PI; NIH NS094393, PI; NIH NS093177, PI

    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. (1) model of myotonic dystrophy, Isis Pharmaceuticals

    Royalty Payments, Technology or Inventions:
    1. (1) Licensing for mouse model of myotonic dystrophy,

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  29. Bjarne Udd, MD, PhD,
  30. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. Neuromuscular Disorders, editorial board member, 14 years and associate executive Editor 4 years

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    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. Finnish Academy grant for the study of distal myopathies 2005-2010 Finnish Academy grant for the study of distal myopathies 2011-2014 Finnish Academy grant for the study of titinopathies 2015-2019

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. the Sigrid Juselius foundation grant for the study of distal myopathies 2017-2019 the Jane and Aatos Erkko foundation for NGS in undetermined myopathies 2018-20

    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

  31. Paul Formaker,
  32. 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. NONE

    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

  33. on behalf of the Myotonic Dystrophy Foundation
  1. Ludwig-Maximilians- Universität (BS); Friedrich-Baur-Institut (FM), Munich, Germany; Institut de Myologie (GB), Paris, France; U.O. Neurologia (BF), IRCCS Policlinico San Donato, Milan, Italy; Vall d'Hebron University Hospital (JG), Barcelona, Spain; University of Rochester (CH, JH, RM, CT), Rochester, NY; University Hospital of Bonn (CK), Germany; Medical University of Warsaw (AK-P), Poland; University of Texas (RK) MD Anderson cancer center; Medical University of Warsaw (AL), Poland; Department of Biomedical Sciences for health (GM), University of Milan, Italy; Tampere University (BU), Finland; Myotonic Dystrophy Foundation (PF), San Francisco.
  1. Correspondence
    Paul Formaker Leah.Hellerstein{at}myotonic.org
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