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January 29, 2019; 92 (5) Editorial

Heterogeneity, urgency, generalizability, and enrollment

The HUGE balance in ALS trials

Chafic Karam, James D. Berry
First published January 9, 2019, DOI: https://doi.org/10.1212/WNL.0000000000006837
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Article Information

vol. 92 no. 5 215-216
DOI: 
https://doi.org/10.1212/WNL.0000000000006837
PubMed: 
30626648
Published By: 
Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology
Print ISSN: 
0028-3878
Online ISSN: 
1526-632X
History: 
  • First Published January 9, 2019.

Article Versions

Copyright & Usage: 
© 2019 American Academy of Neurology

Author Disclosures

    1. Chafic Karam, MD and
    2. James D. Berry, MD, MPH
  1. Chafic Karam, MD and
    2. Scientific Advisory Boards:

    1. I serve on DMSB for a Phase 2/3 Trial of Arimoclomol in Inclusion Body Myositis (IBM)

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. I have received speaker honoraria from Akcea, Alnylam, Alexion and CSL behring.

    Editorial Boards:

    1. I served on the editorial board of the Neurology Resident and Fellow section. I served as Deputy Editor, Neurology Write Click, Dispute and Debate.

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. I have received consulting honoraria from Akcea, Alnylam, Alexion, Biogen, Cytokinetics, Genzyme and CSL Behring.

    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

  2. James D. Berry, MD, MPH
    3. Scientific Advisory Boards:

    1. (1) MT Pharma (commercial entity) - attended one-day scientific advisory meeting (2) Denali Therapeutics (commercial entity) - attended one-day scientific advisory meeting (3) Orion Corporation (commercial entity) - attended one- day scientific advisory meeting (4) Anelixis Therapeutics (commercial entity) - advisor to company (5) Mayo Clinic (non-profit entity) - DSMB member for ALS stem cell trial

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. (1) ALS Association (non-profit entity) - reimbursed for travel to ALS patient symposium (2) MDA (non-profit entity) - reimbursed for travel to scientific conference (3) ALS One (non-profit entity) - reimbursed for travel to ALS advocacy meeting (4) ALS Finding a Cure (non-profit entity) - reimbursed for travel to ALS research meetings

    Editorial Boards:

    1. Wife (Ann Shinn) - Neuropsychopharmacology - Editorial Board Member

    Patents:

    1. MicroRNAs in neurodegenerative disorders (WO2013055865)

    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. (1) Voyager Therapeutics - Commercial Entity - Fellowship Funding (2) Neuraltus Pharmaceuticals - Commercial entity - Site Investigator for Trial (3) Cytokinetics - Commercial entity - Site Investigator for Trial (4) Brainstorm Cell Therapeutics - Commercial entity - Site Investigator for Trial (5) Amylyx Pharmaceuticals - Commercial entity - Site Investigator for Trial (6)

    Research Support, Government Entities:

    1. (1) NIH/NINDS (PI: Steven M. Greenberg) Co-Investigator, 2011-2018 (2) NIH R01DC013547 (PI: Jordan Green) Co-PI, 2014-2019 (3) NIH/NINDS R21 NS101673 (PI: Butovsky) Co-PI, 2017-2019 (4) NIH/NINDS R21 NS104609 (PI: Butovsky) Co-PI, 2018-2020 (5) NIH-R01 DC017291 (PIs: Green and Yunusova) Co-I, 2018- 2023

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. (1) Muscular Dystrophy Association (2) ALS Finding a Cure (3) ALS Association (4) ALS One

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. MicroRNAs in neurodegenerative disorders (WO2013055865) - Licensing royalty

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  1. From the Department of Neurology (C.K.), Oregon Health & Science University, Portland; and Department of Neurology (J.D.B.), Massachusetts General Hospital, Boston.
  1. Correspondence
    Dr. Karam chafickaram{at}gmail.com
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