levosimendan oral (TNX-103) / Orion Corp, Tenax Therap 
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  • ||||||||||  levosimendan oral (ODM-109) / Orion Corp
    [VIRTUAL] Determinants of clinical response to levosimendan in the REFALS phase 3 study in people with ALS () -  Mar 18, 2021 - Abstract #AAN2021AAN_3032;    
    P3
    The REFALS study explored the clinical effects of oral levosimendan during prolonged treatment in people with ALS...83% and 17.5% patients were taking riluzole and edaravone, respectively... Although the REFALS study of levosimendan was not positive, subgroup analyses may be of value in identifying patient groups with a stronger treatment effect and inform future trial design.
  • ||||||||||  levosimendan oral (TNX-103) / Orion Corp, Tenax Therap
    Trial completion, Enrollment change, Trial completion date, Trial primary completion date:  REFALS-ES: Effects of Oral Levosimendan on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis (ALS): Open-Label Extension (clinicaltrials.gov) -  Jan 26, 2021   
    P3,  N=227, Completed, 
    The REFALS trial has provided a unique opportunity to study the potential of routine clinical chemistry measurements as markers to follow ALS disease pathology, which could be useful for managing patients in future clinical trials. Active, not recruiting --> Completed | N=450 --> 227 | Trial completion date: Mar 2021 --> Nov 2020 | Trial primary completion date: Mar 2021 --> Nov 2020
  • ||||||||||  levosimendan oral (ODM-109) / Orion Corp
    Clinical, Journal:  Levosimendan Efficacy and Safety: 20 Years of SIMDAX in Clinical Use. (Pubmed Central) -  Jan 14, 2021   
    A levosimendan oral form is at present under evaluation in the management of amyotrophic lateral sclerosis. To mark the 20 years since the advent of levosimendan in clinical use, 51 experts from 23 European countries (Austria, Belgium, Croatia, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Italy, the Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, the United Kingdom, and Ukraine) contributed to this essay, which evaluates one of the relatively few drugs to have been successfully introduced into the acute HF arena in recent times and charts a possible development trajectory for the next 20 years.
  • ||||||||||  levosimendan oral (TNX-103) / Orion Corp, Tenax Therap
    Trial completion, Trial completion date:  REFALS: Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS (clinicaltrials.gov) -  Oct 12, 2020   
    P3,  N=496, Completed, 
    To mark the 20 years since the advent of levosimendan in clinical use, 51 experts from 23 European countries (Austria, Belgium, Croatia, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Italy, the Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, the United Kingdom, and Ukraine) contributed to this essay, which evaluates one of the relatively few drugs to have been successfully introduced into the acute HF arena in recent times and charts a possible development trajectory for the next 20 years. Active, not recruiting --> Completed | Trial completion date: Oct 2020 --> Jul 2020
  • ||||||||||  levosimendan oral (ODM-109) / Orion
    Clinical, Review, Journal:  Levosimendan Efficacy and Safety: 20 years of SIMDAX in Clinical Use. (Pubmed Central) -  Jul 28, 2020   
    A levosimendan oral form is at present under evaluation in the management of amyotrophic lateral sclerosis. To mark the 20 years since the advent of levosimendan in clinical use, 51 experts from 23 European countries (Austria, Belgium, Croatia, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Italy, the Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, UK and Ukraine) contributed to this essay, which evaluates one of the relatively few drugs to have been successfully introduced into the acute heart failure arena in recent times and charts a possible development trajectory for the next 20 years.
  • ||||||||||  levosimendan oral (ODM-109) / Orion
    Clinical, Journal:  Levosimendan Efficacy and Safety: 20 years of SIMDAX in Clinical Use. (Pubmed Central) -  Jul 9, 2020   
    A levosimendan oral form is at present under evaluation in the management of amyotrophic lateral sclerosis. To mark the 20 years since the advent of levosimendan in clinical use, 51 experts from 23 European countries (Austria, Belgium, Croatia, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Italy, the Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, UK, and Ukraine) contributed to this essay, which evaluates one of the relatively few drugs to have been successfully introduced into the acute heart failure arena in recent times and charts a possible development trajectory for the next 20 years.
  • ||||||||||  levosimendan oral (TNX-103) / Orion Corp, Tenax Therap
    Trial completion, Trial primary completion date:  Effects of ODM-109 on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis (clinicaltrials.gov) -  Nov 28, 2017   
    P2,  N=66, Completed, 
    Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial primary completion date: Sep 2016 --> May 2017
  • ||||||||||  levosimendan oral (TNX-103) / Orion Corp, Tenax Therap
    Enrollment closed, Enrollment change:  Effects of ODM-109 on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis (clinicaltrials.gov) -  Aug 31, 2016   
    P2,  N=66, Active, not recruiting, 
    Active, not recruiting --> Completed | Trial primary completion date: Sep 2016 --> May 2017 Recruiting --> Active, not recruiting | N=54 --> 66
  • ||||||||||  levosimendan oral (TNX-103) / Orion Corp, Tenax Therap
    Trial completion:  Peroral Levosimendan in Chronic Heart Failure (clinicaltrials.gov) -  Feb 22, 2014   
    P2,  N=300, Completed, 
    Not yet recruiting --> Recruiting No longer recruiting --> Completed