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International Alliance of ALS/MND Associations

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  • What is ALS/MND
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  • Support for PALS & CALS
    • Fundamental Rights for People with ALS/MND and Caregivers
    • Research
      • Voice Preservation
      • Open Science
      • Expanded Access
      • Understanding ALS/MND Research
      • Improving Regulatory Pathways
      • Right to Try
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      • Unproven (Off-Label) Treatments
      • Open Label Extension
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    • Drugs in Development
      • AB Science – Masitinib
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      • Collaborative Medicinal Development – CuATSM
      • ILB – Tikomed
      • Kadimastem – AstroRx
      • Mitsubishi Tanabe Pharma America – Oral Edaravone
      • Neuronata-R/Lenzumestrocel
      • NeuroSense – PrimeC
      • Neuvivo – NP001
      • Prilenia Therapeutics – Pridopidine
      • T Regulatory Cell Therapies
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    • Approved Drugs
      • Nuedexta
      • Radicava/Edaravone
      • Riluzole/Tiglutik
      • Rozebalamin/Methylcobalamin
      • Tofersen/Qalsody
    • Drugs No Longer in Development
      • Amylyx – AMX0035
      • Collaborative Medicinal Development – CuATSM
      • Cytokinetics – Reldesemtiv
      • Orphazyme – Arimoclomol
      • TUDCA Trial
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Open Label Extension

When clinical trials end, the participants typically stop taking the study drug until it receives approval from their country’s regulatory agency. But if patients are benefitting from the drug and have no other treatment options without it, they are sometimes allowed to continue taking the drug as part of an open-label extension (OLE). People are only allowed to participate in an OLE if they’ve completed the initial portion of the study.

OLEs often follow phase 3 trials, the last phase before regulatory approval. But it is not uncommon for them to follow phase 1 or phase 2 trials for ALS/MND treatments. Many organizations are strongly advocating for the inclusion of some form of OLE in all industry-supported clinical trials.

OLEs are an act of compassion for people with serious illnesses like ALS/MND who participate in clinical trials. ALS/MND is not only severe, but clinical trial participants are making a sacrifice by willing to volunteer knowing there is a chance they may end up on placebo. In these cases, everyone should have access to an OLE that could maximize the potential benefit of the treatment, should it ultimately prove effective.

Scientific Gain

Besides benefitting trial participants directly, a well-designed OLE can also provide useful data about the therapy that could benefit more people. OLEs often extend a trial for months, allowing researchers to collect more information on the long-term efficacy, tolerability, and safety of the drug. However, the data’s validity is limited by the fact that participants know they are receiving the treatment. This could create a placebo effect that makes the drug’s benefit appear greater only because participants believe it should work.

The Alliance believes that open label extension studies must be incorporated into all clinical trial design and protocols to ensure people living with ALS/MND can continue to access experimental therapies once their participate in a clinical trial has ended.

Primary Sidebar

Advocacy

  • Advocacy Toolkit

  • Mahmood Anwar, UK

    Mahmood Anwar, UK

  • Timmy, ALS Liga

    Timmy, ALS Liga

  • Malcolm Buck, Australia

    Malcolm Buck, Australia

  • Jose Rivero Muñoz, Diagnosed 2015, FYADENMAC, Mexico

    Jose Rivero Muñoz, Diagnosed 2015, FYADENMAC, Mexico

  • Ian Roberts

    Ian Roberts

  • Phil Rossall, MND-Association, UK

    Phil Rossall, MND-Association, UK

  • Zelina Brito, Diagnosed 2018, Brazil

    Zelina Brito, Diagnosed 2018, Brazil

  • Wiebke Braach, Deutsche Gesellschaft für Muskelkranke, Germany

    Wiebke Braach, Deutsche Gesellschaft für Muskelkranke, Germany

  • Brian Parsons

    Brian Parsons

  • Karl Hughes, Diagnosed 2010 , IMNDA,  Ireland

    Karl Hughes, Diagnosed 2010 , IMNDA, Ireland

  • Alfredo Santos, Diagnosed 2013 , ACELA, Colombia

    Alfredo Santos, Diagnosed 2013 , ACELA, Colombia

  • Roxana Canova, Diagnosed 2012 ,  Asociación ELA Argentina

    Roxana Canova, Diagnosed 2012 , Asociación ELA Argentina

  • Claudette Sturk, ALS Society of Canada

    Claudette Sturk, ALS Society of Canada
    Picture2

  • Paul Launer, USA

    Paul Launer, USA

  • Jason Goodman, Les Turner ALS Foundation, USA

    Jason Goodman, Les Turner ALS Foundation, USA

  • Bayley, Australia

    Bayley, Australia

  • Amparo Muriel Engativa, Colombia

    Amparo Muriel Engativa, Colombia

  • Dawn Morton, Diagnosed 2014 , MND Scotland, UK

    Dawn Morton, Diagnosed 2014 , MND Scotland, UK

  • João Marcos Andrietta, Diagnosed 2008 , ABrELA, Brazil

    João Marcos Andrietta, Diagnosed 2008 , ABrELA, Brazil

  • Chun Ju Xiao, China

    Chun Ju Xiao, China

  • Jan Zuring, Diagnosed 2010 , The Netherlands

    Jan Zuring, Diagnosed 2010 , The Netherlands

  • Michel Perrozzo, ARSLA, Diagnosed 2015, France

    Michel Perrozzo, ARSLA, Diagnosed 2015, France

  • JP

    JP

  • Elkin Ramiro Gaviria Muñoz, Diagnosed December 2018

    Elkin Ramiro Gaviria Muñoz, Diagnosed December 2018

  • Steve

    Steve

  • Mauril Belanger

    Mauril Belanger

  • Leon Ryba, Argentina

    Leon Ryba, Argentina

  • Bjarne Hytjanstorp, ALS Norge, Norway

    Bjarne Hytjanstorp, ALS Norge, Norway

  • Steve Gallagher, ALS Society of Canada

    Steve Gallagher, ALS Society of Canada
    Picture1

  • Carlos Alberto Arango, Colombia

    Carlos Alberto Arango, Colombia

  • Jorge Melo, ABrELA, Brazil

    Jorge Melo, ABrELA, Brazil

  • Norm MacIsaac,  ALS Society of Canada,  ALS Society of Quebec,  Diagnosed 2014

    Norm MacIsaac, ALS Society of Canada, ALS Society of Quebec, Diagnosed 2014

  • Zabun Nassar, MND Association, Diagnosed 2016, England

    Zabun Nassar, MND Association, Diagnosed 2016, England

  • Nicholas (Nic) Bowman, MND Association of South Africa,  Diagnosed 2016,  Australia

    Nicholas (Nic) Bowman, MND Association of South Africa, Diagnosed 2016, Australia

  • Oliver Juenke, Germany

    Oliver Juenke, Germany

  • Carlos Gomez Matallanas, Diagnosed 2014 , FUNDELA, Spain

    Carlos Gomez Matallanas, Diagnosed 2014 , FUNDELA, Spain

  • 83

    83

  • Yessenia Hernandez Mendoza, Apoyo Integral Gila A.C., Diagnosed 2018, Mexico

    Yessenia Hernandez Mendoza, Apoyo Integral Gila A.C., Diagnosed 2018, Mexico

  • Maurice Leclerc, Canada

    Maurice Leclerc, Canada

  • Irene McCaughey, Diagnosed 2011,  MND Australia

    Irene McCaughey, Diagnosed 2011, MND Australia

  • Jeff Sutherland

    Jeff Sutherland
    jspic

  • Maria Lucia Wood Saldanha, Associação Pró-Cura da ELA, Brazil

    Maria Lucia Wood Saldanha, Associação Pró-Cura da ELA, Brazil

  • Shay Rishoni, Diagnosed 2011 - Prize4Life, Israel

    Shay Rishoni, Diagnosed 2011 – Prize4Life, Israel

  • IMG_2658

    IMG_2658

  • Kris Van Reusel, Belgium

    Kris Van Reusel, Belgium

  • Ismail Gokcek, Turkey

    Ismail Gokcek, Turkey
    ismail_gokcek_alsmnd_tr

  • Ada Garrido Benavidez, Diagnosed 2016,  FYADENMAC, Mexico

    Ada Garrido Benavidez, Diagnosed 2016, FYADENMAC, Mexico

  • Rolf Mauch, Association ALS Switzerland, Diagnosed 2015

    Rolf Mauch, Association ALS Switzerland, Diagnosed 2015

  • Margarita Pizarro, Asociacion ELA Argentina, Diagnosed 2017, Argentina

    Margarita Pizarro, Asociacion ELA Argentina, Diagnosed 2017, Argentina

  • Claudia Gotti, Brazil

    Claudia Gotti, Brazil

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