Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT03948178) enrolled 227 people, all of whom received a medicine called levosimendan. The trial was measuring a number of things related to safety and body function over time, including adverse events (unwanted health events that occurred during the study), heart rate, heart electrical activity (via ECG recordings), lung breathing capacity, a standard ALS function score, and whether participants withdrew from the study due to their disease getting worse. The reported data shows that none of the 227 participants were recorded as having "completed" the trial under the study's own definitions, though this does not necessarily mean anything unexpected — how studies define completion can vary. The reported data shows that 161 out of 227 participants experienced at least one adverse event during the study. For heart rate, a range of values were recorded at different time points, with the average (mean) resting heart rate reported as 75.8 beats per minute at one measured point, and changes from the starting point ranging from around 3.5 to 15.0 beats per minute across the various time points. For the ECG heart recordings, the number of participants with certain findings ranged from 11 to 69 depending on the specific measurement being reported. Regarding the disease progression secondary outcome, 164 participants withdrew from the study due to disease progression, and 30 did not. For breathing capacity (slow vital capacity), changes from the starting point ranged from about +2.1% to -7.3% of predicted normal across different time points and positions. The ALS respiratory function score (on a 0–12 scale where 12 is normal) showed a reported change of -1.2 points, with a reported average score of 9.4 at one recorded point. It is important to note that the data as submitted provides a series of numbers across multiple time points, but full context — such as which numbers correspond to which time points — was not always clearly labelled in the submitted data, so some figures cannot be described in further detail here. Any figures not fully described above were not reported in a way that allowed plain attribution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 34536404) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Motor Neurone Disease Trial, Terminated
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You gave your agreement (written or verbal) to take part in the study
- You completed the full 48 weeks of treatment in the related REFALS study
- You are able to swallow capsules at the time you finished the 48-week REFALS study treatment
Who may not be able to join:
- You have developed a serious heart or blood vessel problem (such as a heart attack, heart failure, irregular heartbeat, stroke, or certain heart rhythm issues) or these conditions got significantly worse during the REFALS study
- Your heart rate is repeatedly over 100 beats per minute after resting for 5 minutes (this would be checked twice to confirm)
- Your top blood pressure reading is below 90 mmHg
- You have severe kidney problems, as shown by certain blood test results at your 48-week REFALS visit, or you are currently on dialysis
- You have severe liver problems, as determined by the study doctor
- You are a woman of childbearing age who does not have a negative pregnancy test, or who is not committed to using a highly effective form of contraception during the study and for one month after the last dose (women who are post-menopausal, surgically sterilised, or have had a hysterectomy are not affected by this rule)
- The study doctor considers you to be actively at risk of suicide
- You have any other significant medical condition (affecting the heart, stomach, liver, kidneys, nervous system, or mental health) that the study doctor believes could affect the study results or put your health at risk
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Geneviève Nadeau, CSD, Orion Corporation, Orion Pharma
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Adverse Events Recording; Pulse/Heart Rate Assessment; 12-lead Electrocardiogram Assessments
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.