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March 07, 2023; 100 (10) Research Article

Efficacy and Safety of N-Acetyl-l-Leucine in Children and Adults With GM2 Gangliosidoses

Kyriakos Martakis, Jens Claassen, Jordi Gascon-Bayari, Nicolina Goldschagg, Andreas Hahn, Anhar Hassan, Anita Hennig, Simon Jones, Richard Kay, Heather Lau, Susan Perlman, Reena Sharma, Susanne Schneider, Tatiana Bremova-Ertl
First published December 1, 2022, DOI: https://doi.org/10.1212/WNL.0000000000201660
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Article Information

vol. 100 no. 10 e1072-e1083
DOI: 
https://doi.org/10.1212/WNL.0000000000201660
PubMed: 
36456200
Published By: 
Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology
Print ISSN: 
0028-3878
Online ISSN: 
1526-632X
History: 
  • Received May 26, 2022
  • Accepted in final form October 21, 2022
  • First Published December 1, 2022.

Article Versions

Copyright & Usage: 
© 2022 American Academy of Neurology

Author Disclosures

    1. Kyriakos Martakis, MD,
    2. Jens Claassen, MD,
    3. Jordi Gascon-Bayari, MD,
    4. Nicolina Goldschagg, MD,
    5. Andreas Hahn, MD,
    6. Anhar Hassan, MBBCh,
    7. Anita Hennig, MD,
    8. Simon Jones, MD,
    9. Richard Kay, PhD,
    10. Heather Lau, MD,
    11. Susan Perlman, MD,
    12. Reena Sharma, MD,
    13. Susanne Schneider, MD and
    14. Tatiana Bremova-Ertl, MD, PhD
  1. Kyriakos Martakis, MD,
    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. 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

  2. Jens Claassen, MD,
    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. NONE

    Consultancies:

    1. The Author recieved consulting fees <br><br>for blinded rater service from IntraBio

    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. Jordi Gascon-Bayari, MD,
    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. 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

  4. Nicolina Goldschagg, MD,
    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. NONE

    Consultancies:

    1. (1) IntraBio Inc., principal place of business at University <br>of Oxford Begbroke Science Park, Begbroke Hill, Woodstock <br>Road, Begbroke OX5 1PF: central reviewer team

    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. Andreas Hahn, MD,
    6. 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

  6. Anhar Hassan, MBBCh,
    7. Scientific Advisory Boards:

    1. 1) DSMB for Clinical Trial Readiness for SCA1 and SCA3<br><br>(U01) (no compensation)

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. None

    Editorial Boards:

    1. (1) Parkinsonism and Related Disorders, Editorial Board <br><br>Member, 2016-2021. No personal 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. (1) Intrabio -research support to fund patient evaluation during the study

    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

  7. Anita Hennig, 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

  8. Simon Jones, MD,
    9. Scientific Advisory Boards:

    1. 1)<br>Sanofi<br>Takeda<br>Biomarin<br>Alexion<br>Mina<br>Orchard<br>Avrobio<br>Orphazyme

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. travel/speaking<br>Sanofi<br>Takeda<br>Biomarin<br>Alexion<br>Mina<br>Orchard<br>Avrobio<br>Orphazyme

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Sanofi<br>Takeda<br>Biomarin<br>Alexion<br>Mina<br>Orchard<br>Avrobio<br>Orphazyme

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Sanofi<br>Biomarin<br>Orchard<br>Avrobio

    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. Richard Kay, PhD,
    10. Scientific Advisory Boards:

    1. Minoryx (DSMB)

    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. Minoryx

    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

  10. Heather Lau, MD,
    11. Scientific Advisory Boards:

    1. 1. National Tay Sachs and <br>Allied Diseases Scientific<br>Advisory Board<br>2. Adult Polyglucosan Body <br>Disorder Foundation <br>Scientific<br>Advisory Board<br>3. Takeda Advisory Board<br>4. Sanofi Genzyme Advisory <br>Board

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. National Tay Sachs and <br>Allied Diseases Foundation <br>travel<br>MPS Society<br>Fabry Information and <br>Support Group<br>Muscular dystrophy society <br>Sanofi Genzyme <br>honoraria<br>Ultragenyx travel

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. Ultragenyx Executive <br>Director, Global Clinical <br>Development, 1.5yrs

    Consultancies:

    1. 1. Sanofi Genzyme<br>2. Pfize<br>4. Ultragenyx<br>5. Takeda<br>6. Amicus<br>8. Biomarin<br>9. Taysha

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. 1. Sanofi Genzyme<br>2. Takeda<br>3. Amicus<br>4. Mallinckrodt<br>5. Biomarin<br>6. Ultragenyx<br>7. Pfizer<br>8. Protalix<br>9. Sangamo<br>10. Prevail<br>11. ASPA therapeutics

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. National Tay Sachs and <br>Allied Diseases Foundation <br>Grant

    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. Ultragenyx

    Legal Proceedings:

    1. NONE

  11. Susan Perlman, MD,
    12. Scientific Advisory Boards:

    1. (1) National Ataxia Foundation Medical Research Advisory <br>Board.<br>Employment, Commercial Entity: <br>(1) UCLA Medical Center, fulltime staff physician, 40 years

    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. (1) Santhera Phamaceuticals<br>(2) Edison Pharmaceuticals<br>(3) Viropharma Pharmaceuticals<br>(4) Horizon Pharmaceuticals<br>(5) Reata Pharmaceuticals<br>(6) Biohaven Pharmaceuticals<br>(7) Teva Pharmaceuticals<br>(8) Takeda Pharmaceuticals<br>(9) Cadent Pharmaceuticals

    Research Support, Government Entities:

    1. (1) ARRAS funding via the RDN-CRC, subcontracted from <br>University of Florida, PI at UCLA for the study 2009-2011

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. (1) Friedreich Ataxia Research Alliance<br>(2) National Ataxia 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

  12. Reena Sharma, MD,
    13. 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

  13. Susanne Schneider, MD and
    14. Scientific Advisory Boards:

    1. None

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. None

    Editorial Boards:

    1. editorial board member of Journal of Neurology and <br>Parkinsonism Related Disorders and Clinical Parkinsonism <br>Related Disorders (all without financial 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

  14. Tatiana Bremova-Ertl, MD, PhD
    15. Scientific Advisory Boards:

    1. None

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. (1) Actelion Ltd, speaker honoraria, funding for travel to <br>conferences.<br>(2) Sanofi-Genzyme, funding for travel to speak at <br>conferences.

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. (1) University Hospital Inselspital, Inselgruppe hospital

    Consultancies:

    1. (1) Actelion, consultancy <br>(2) Sanofi Genzyme, consultancy<br>(3) Intrabio, payed services as blinded reviewer

    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) German Federal Ministry of Education and Research,<br>grant code 01 EO 0901, Site Investigator, 2011-2014

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. (1) Baasch-Medicus Stiftung, Grant No. baas31, 07/2022-06/2024<br>(2) InnoSuisse, Grant No. 55424.1 IP-LS, 10/22-04/23<br>(3) University of Bern, UniBE Initiator Grant 2020

    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

  1. From the Department of Pediatric Neurology (K.M., Andreas Hahn), University Children's Hospital (UKGM) and Medical Faculty, Justus Liebig University of Giessen, Giessen, Germany; Department of Pediatrics (K.M.), Medical Faculty and University Hospital, University of Cologne, Cologne, Germa; Department of Neurology (J.C.), Essen University Hospital, University of Duisburg-Essen, Germany; Department of Neurocritical Care, Neurological and Neurosurgical First Stage Rehabilitation and Weaning, MediClin Klinik Reichshof, Germany; Department of Neurologic Diseases and Neurogenetics (J.G.-B.), Institut D'Investigació Biomèdica de Bellvitge, Barcelona, Spain; Department of Neurology (N.G., Anita Hennig, S.S.), Ludwig Maximilian University of Munich, Germany; Department of Neurology (Anhar Hassan), Mayo Clinic, Rochester, MN, United States; Willink Unit (S.J.), Manchester Centre for Genomic Medicine, Royal Manchester Children's Hospital, University of Manchester, United Kingdom; RK Statistics, Brook House, Mesne Lane, Bakewell DE45 1AL, United Kingdom 9. Division of Neurogenetics, New York University Langone, NY, United States; Department of Neurology (H.L.), New York University Langone School of Medicine, NY, United States; Department of Neurology (S.P.), University of California Los Angeles, CA, United States; Department of Adult Metabolic Medicine (R.S.), Salford Royal Foundation NHS Trust, United Kingdom; and Department of Neurology (T.B.-E.), University Hospital Bern (Inselspital), Switzerland.
  1. Correspondence
    Dr. Martakis kyriakos.martakis{at}paediat.med.uni-giessen.de
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