• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Email
  • Facebook
  • LinkedIn
  • Twitter
  • YouTube

International Alliance of ALS/MND Associations

  • Members' Login
  • Contact
  • Join the Alliance
  • Donate
  • What is ALS/MND
  • Find a Member Association
  • 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
      • US FDA Orphan Drug Designation
      • Unproven (Off-Label) Treatments
      • Open Label Extension
    • Advocacy
      • Advocacy Toolkit
      • Emergency Preparedness Toolkit
      • Equitable Access to Therapies
      • Recommendations for Trial Sponsors
    • Clinical Care
      • Genetic Counselling & Testing
      • Mental Health Support
      • Nursing and Symptom Management
      • Nutrition and Swallowing
      • Occupational Therapy and Activities of Daily Living
      • Physiotherapy and Mobility
      • Respiratory Care
      • Speech Therapy and Communication
      • Support for Family & Caregivers
      • Technology
      • Global Clinic Locator
    • Drugs in Development
      • AB Science – Masitinib
      • BrainStorm Cell Therapeutics – NurOwn
      • Clene Nanomedicine – CNM-Au8
      • 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
      • SOD1 Therapies & Trials
    • 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
  • Support for Health Professionals
    • Breaking the News in ALS/MND
    • Diagnostic Delay (in development)
  • Events/Programs
    • Calendar of Events/Programs
    • Alliance Meeting
    • Allied Professionals Forum
    • Alliance Webinars
    • ALS/MND Connect
    • Global Day Calendar
    • March of Faces
    • Patient Fellows Program
    • Global CRLI
    • International Symposium
  • About
    • Who We Are
    • ALS/MND Health Literacy Map
    • Board of Trustees
    • Advisory Councils/Committees
      • Scientific Advisory Council
      • PALS and CALS Advisory Council
      • Innovation and Technology Council
      • Advocacy and Public Policy Forum
      • Research Directors Forum
      • Governance Committee
      • Finance Committee
    • Staff
    • History
    • Archives
      • Newsletters
      • Meetings
    • Awards
      • Student Innovation Award
      • Forbes Norris Award
      • Humanitarian Award
      • Allied Health Professional Award
  • Members
    • Member Registration
    • Forgot Password

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

  • 727747090571358167

    727747090571358167

  • Osiel Mendoza, Diagnosed 2016 ,  ALS Therapy Development Institute, USA

    Osiel Mendoza, Diagnosed 2016 , ALS Therapy Development Institute, USA

  • Wiebke Braach, Deutsche Gesellschaft für Muskelkranke, Germany

    Wiebke Braach, Deutsche Gesellschaft für Muskelkranke, Germany

  • Tammy Moore and Eddy Lefrancois

    Tammy Moore and Eddy Lefrancois

  • Mary Thomas, Diagnosed 2013 , MND Australia

    Mary Thomas, Diagnosed 2013 , MND Australia

  • Alfredo Santos, Diagnosed 2013 , ACELA, Colombia

    Alfredo Santos, Diagnosed 2013 , ACELA, Colombia

  • Antonio Ventriglia,  ALS Liga Belgium,  Diagnosed 2013

    Antonio Ventriglia, ALS Liga Belgium, Diagnosed 2013

  • Luis Antonio Pimenta Lima, Brazil

    Luis Antonio Pimenta Lima, Brazil

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

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

  • Andrietta

    Andrietta

  • Steve

    Steve

  • Animesh Kumar, Diagnosed 2013 , Asha Ek Hope Foundation, India

    Animesh Kumar, Diagnosed 2013 , Asha Ek Hope Foundation, India

  • Roy

    Roy
    roy

  • Ian Roberts

    Ian Roberts

  • Sanjay Kumar Srivastava, Asha Ek Hope Foundation for ALS/MND, Diagnosed 2018, India

    Sanjay Kumar Srivastava, Asha Ek Hope Foundation for ALS/MND, Diagnosed 2018, India

  • Erwin Coppejans, Diagnosed 2007 , ALS Liga België, Belgium

    Erwin Coppejans, Diagnosed 2007 , ALS Liga België, Belgium

  • Ismail Gokcek, Turkey

    Ismail Gokcek, Turkey
    ismail_gokcek_alsmnd_tr

  • Philip Brindle,  MND Association,  Diagnosed 2015,  England

    Philip Brindle, MND Association, Diagnosed 2015, England

  • Jon Newsome, Les Turner ALS Foundation, USA

    Jon Newsome, Les Turner ALS Foundation, USA

  • Anita Forte, Les Turner ALS Foundation, USA

    Anita Forte, Les Turner ALS Foundation, USA

  • Claire Garry, USA

    Claire Garry, USA
    20200117_214643

  • Ian Gale, MND Australia

    Ian Gale, MND Australia

  • Carlos Alberto Báez Murillo, ACELA, Colombia

    Carlos Alberto Báez Murillo, ACELA, Colombia

  • Fabio Carvalho, Associação Pró-Cura da ELA, Brazil

    Fabio Carvalho, Associação Pró-Cura da ELA, Brazil

  • Frank "Papa" Taylor

    Frank “Papa” Taylor

  • Mike Rannie,  ALS Canada,  Diagnosed 2017

    Mike Rannie, ALS Canada, Diagnosed 2017

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

    Margarita Pizarro, Asociacion ELA Argentina, Diagnosed 2017, Argentina

  • Maria Santos Garcia Tellez, Diagnosed 2017 , FYADENMAC, Mexico

    Maria Santos Garcia Tellez, Diagnosed 2017 , FYADENMAC, Mexico

  • Hanne Stenmose, Muskelsvindfonden, Denmark

    Hanne Stenmose, Muskelsvindfonden, Denmark

  • Anthony (Tony) Lynch, MND New South Wales, Diagnosed 2016, Australia

    Anthony (Tony) Lynch, MND New South Wales, Diagnosed 2016, Australia

  • Phil Rossall, MND-Association, UK

    Phil Rossall, MND-Association, UK

  • Ian and Teresa Roberts

    Ian and Teresa Roberts

  • David Watson,  MND Scotland,  Diagnosed 2018

    David Watson, MND Scotland, Diagnosed 2018

  • Claudette Sturk, ALS Society of Canada

    Claudette Sturk, ALS Society of Canada
    Picture2

  • Liz Ogg, Diagnosed 2013 , MND Scotland, UK

    Liz Ogg, Diagnosed 2013 , MND Scotland, UK

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

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

  • Eric Von Schaumburg, USA

    Eric Von Schaumburg, USA

  • Sam Hayden-Harler, Motor Neurone Disease (MND) Association, UK

    Sam Hayden-Harler, Motor Neurone Disease (MND) Association, UK

  • unnamed

    unnamed

  • Marcelo Farinelli, Diagnosed 2006, ABrELA, Brazil

    Marcelo Farinelli, Diagnosed 2006, ABrELA, Brazil

  • Lucy Lintott, Diagnosed 2013 , MND Scotland, UK

    Lucy Lintott, Diagnosed 2013 , MND Scotland, UK

  • Daniel Hare

    Daniel Hare

  • Marco Antonio Alvarez Mercado, Mexico

    Marco Antonio Alvarez Mercado, Mexico

  • Jorge Melo, ABrELA, Brazil

    Jorge Melo, ABrELA, Brazil

  • Liong Ting Ngu, MND Malaysia, Diagnosed 2014

    Liong Ting Ngu, MND Malaysia, Diagnosed 2014

  • Glen Elison,  ALS Hope Foundation,  Diagnosed 2019,  USA

    Glen Elison, ALS Hope Foundation, Diagnosed 2019, USA

  • Karl Hughes, Diagnosed 2010 , IMNDA,  Ireland

    Karl Hughes, Diagnosed 2010 , IMNDA, Ireland

  • Margreth Burger-Saile, Diagnosed 2011,  ALS Schweiz,  Switzerland

    Margreth Burger-Saile, Diagnosed 2011, ALS Schweiz, Switzerland

  • Irene McCaughey, Diagnosed 2011,  MND Australia

    Irene McCaughey, Diagnosed 2011, MND Australia

  • Andrea Zicchieri, Associazione conSLAncio Onlus, Italy

    Andrea Zicchieri, Associazione conSLAncio Onlus, Italy
    AndreaZicchieri_conSLAncioItaly

Learn more about the March of Faces

Latest Tweets

  • Just now

Footer

Subscribe to our Bi-Monthly Newsletter

Sign up to receive updates and to hear what's going on in the International Alliance of ALS/MND Associations.

"*" indicates required fields

 
This field is for validation purposes and should be left unchanged.
  • Email
  • Facebook
  • LinkedIn
  • Twitter
  • YouTube
Return to top of page

Contact | Disclaimer | Privacy Notice & Cookies | Sitemap

Copyright © 2025 The International Alliance of ALS/MND Associations. All rights reserved.


Registered in England: Charity Number 1079504 · Site built by graphics.coop · Powered by WordPress · Members' login