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REFALS

What is REFALS?

REFALS is a phase 3 clinical trial that is currently being undertaken at various sites around the world. The study is examining whether taking oral levosimendan can improve or preserve respiratory function in patients with MND. The long-term tolerability and safety of levosimendan in MND patients will be evaluated as part of this trial, assessing up to 48 weeks of exposure to the drug.
 

What is involved?

If you meet the eligibility criteria, you would receive either oral levosimendan or a placebo for up to 48 weeks. The study is a double-blind study, so participants would not be told whether they are taking the levosimendan or the placebo. The treatment would have to be taken once or twice a day, depending on the study dose administered by the facility you attend. Throughout the trial you will have regular visits with the clinic and periodic telephone assessments would also be conducted. At clinic visits participants would be asked to perform a Slow Vital Capacity (SVC) measurement to assess breathing ability, and blood samples would be taken.
 
If you think you meet the following eligibility criteria and are interested in being involved in this trial then please speak to your neurologist, who may be able to refer you to a recruitment centre. Eligibility criteria are as follows:
  • a definitive diagnosis of MND (and be between 12 and 48 months since symptom onset);
  • ability to swallow study treatment capsules;
  • have a sitting SVC of 60-90% of the predicted value at the screening visit;
  • if taking riluzole and/or edaravone, you need to have been on a stable dose for at least 4 weeks before your screening visit; and
  • not currently be on (non-invasive ventilation) NIV.
 
How far off is a treatment?

A possible treatment resulting from this study is years away. This research will provide preliminary data on the long-term tolerability of levosimendan and will also evaluate whether levosimendan is effective in improving supine slow vital capacity in MND patients.
 

Contact details

Please contact your neurologist for information about participating in this trial. The trial is being conducted at the following locations around Australia:
  • Brain and Mind Centre, Camperdown, NSW
  • Royal Brisbane and Women’s Hospital, QLD
  • Flinders Medical Centre, SA
  • Calvary Health Care Bethlehem, VIC
  • Perron Institute for Neurological and Translational Science, WA

 

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