This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS (NCT03505021), a randomized phase 3 study. The primary outcome is Supine Slow Vital Capacity (SVC).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03505021 |
| Phase | Phase 3 |
| Condition | Amyotrophic Lateral Sclerosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 496 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Orion Corporation, Orion Pharma |
| Results posted | Yes |
2. Clinical Question
Population
People with amyotrophic lateral sclerosis enrolled in a randomized study of oral levosimendan. The registry records enrollment of 496, but the specific eligibility criteria and characteristics of the analyzed population are not reported in the registry record.
Intervention
Oral levosimendan, described in the brief summary as 1 -2 mg daily and in the arm description as 1 mg capsules taken once to twice a day. The stated treatment duration was 48 weeks.
Comparator
Placebo for levosimendan, given as an oral capsule once to twice a day for 48 weeks. The brief summary describes allocation in a 2:1 ratio to levosimendan or placebo.
Primary question
Did change from baseline in supine slow vital capacity, expressed as a percentage of predicted normal, differ between the levosimendan and placebo groups at 12 weeks? The registry reports an ANCOVA comparison of the groups’ final values.
3. Trial Design
This was a phase 3, randomized, parallel-group trial comparing oral levosimendan with placebo in people with amyotrophic lateral sclerosis. The registry records quadruple masking. The brief summary describes the study as double-blind and placebo-controlled; both accounts identify masking, but the registry’s masking classification is quadruple. The brief summary also describes the study as multicenter.
The planned treatment period was 48 weeks. Participants were assigned to levosimendan or placebo, with the brief summary giving a 2:1 allocation ratio. The registry records enrollment of 496. The arm counts attached to the primary outcome are 329 for levosimendan and 167 for placebo; these are outcome-record counts and should not be taken as a description of every analysis population.
The primary endpoint was supine slow vital capacity at 12 weeks, expressed as change from baseline and as a percentage of predicted normal. The summary describes assessment of patient function through 48 weeks using the ALSFRS-R and a combined assessment of function and survival. Other outcomes included respiratory events, clinical global impression, dyspnea, and sleep-related scales. Safety monitoring included adverse events, laboratory tests, vital signs, and electrocardiograms. An independent data and safety monitoring board is described in the brief summary.
The registry lists the study as completed, with start on 2018-06-21 and primary completion on 2020-07-23. The specific eligibility criteria, the trial’s sample-size justification, and the detailed statistical analysis plan are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Male or female subjects with a diagnosis of probable or definite ALS according to El Escorial revised criteria, disease duration from symptom onset of 12-48 months, written or verbal IC obtained. Able to swallow study treatment capsules. Sitting SVC between 60-90% of the predicted value at screening visit. Stable riluzole and/or edaravone allowed.
Overall Study
| Stage | Levosimendan | Placebo for Levosimendan |
|---|---|---|
| STARTED | 329 | 167 |
| COMPLETED | 217 | 112 |
| NOT COMPLETED | 112 | 55 |
Reasons for not completing this period:
| Reason | Levosimendan | Placebo for Levosimendan |
|---|---|---|
| Protocol Violation | 1 | 0 |
| Death | 9 | 8 |
| Consent withdrawn by subject | 6 | 1 |
| Lost to Follow-up | 5 | 3 |
| Adverse Event | 26 | 9 |
| Disease progression | 33 | 17 |
| Other | 11 | 5 |
| Personal reason | 21 | 12 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Intention-to-treat (ITT) dataset, including all randomised subjects, was used for the primary evaluation. Sensitivity analyses using full analysis set (FAS) and two per-protocol (PP) datasets (up to 12 weeks and up to 48 weeks) were performed. FAS included all treated subjects with at least one post baseline SVC measurement. PP dataset included all randomised subjects except subjects with relevant major protocol deviations.
| Characteristic | Unit | Levosimendan | Placebo for Levosimendan | Total |
|---|---|---|---|---|
| Participants analysed | 329 | 167 | 496 | |
| Age, Continuous | years | 59 (SD 11.2) | 59.7 (SD 10.8) | 59.3 (SD 11.1) |
| Sex: Female, Male: Female | Participants | 122 | 67 | 189 |
| Sex: Female, Male: Male | Participants | 207 | 100 | 307 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 9 | 1 | 10 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 5 | 3 | 8 |
| Race (NIH/OMB): White | Participants | 305 | 157 | 462 |
| Race (NIH/OMB): More than one race | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 9 | 6 | 15 |
| Region of Enrollment: United States | participants | 105 | 45 | 150 |
| Region of Enrollment: United Kingdom | participants | 8 | 1 | 9 |
| Region of Enrollment: Spain | participants | 44 | 15 | 59 |
| Region of Enrollment: Canada | participants | 25 | 22 | 47 |
| Region of Enrollment: Austria | participants | 6 | 1 | 7 |
| Region of Enrollment: Netherlands | participants | 8 | 8 | 16 |
| Region of Enrollment: Sweden | participants | 19 | 7 | 26 |
| Region of Enrollment: Belgium | participants | 12 | 10 | 22 |
| Region of Enrollment: Ireland | participants | 3 | 2 | 5 |
| Region of Enrollment: Finland | participants | 10 | 3 | 13 |
6. Primary Endpoint
The registry lists the primary outcome as Supine Slow Vital Capacity (SVC), measured over The change from baseline at 12 weeks.
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage |
| Endpoint classification | Continuous Endpoint |
Slow vital capacity (SVC) is a measure of the volume of air a person can exhale after taking a deep breath. The primary outcome was supine SVC: the measurement was taken lying down. The registry describes the endpoint as change from baseline at 12 weeks, expressed as a percentage of predicted normal. This presentation puts the measured respiratory function in relation to a predicted reference value; the registry does not give further details about how that reference was determined.
Change from baseline focuses the comparison on how the measure changed during the study rather than only on the value at the end of follow-up. The 12-week measurement was the primary endpoint, while treatment was described as continuing for 48 weeks. The endpoint therefore addresses an earlier respiratory-function comparison, not the full duration of treatment or every aspect of disease progression.
The registry reports least-squares means for each group, with 95% confidence intervals, and an ANCOVA comparison. In general, an adjusted comparison can account for specified model terms; the terms used in this ANCOVA are not reported in the registry record. The endpoint is one measure of respiratory function and does not by itself describe patient function, survival, symptoms, or safety.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
For the primary comparison, the estimated mean difference was 0.258 percentage points, with a 95% confidence interval from -2.032 to 2.547 and p = 0.825. The estimate is close to zero, and the interval includes zero. In statistical terms, the reported analysis does not establish a difference between groups on this endpoint at 12 weeks. The interval also describes a range of effects compatible with the data under the model; it does not demonstrate that the groups are equivalent.
The group estimates were -6.731 for levosimendan and -6.988 for placebo, each reported as a least-squares mean change from baseline. Their confidence intervals were -8.29 to -5.171 and -9.052 to -4.925, respectively. These are estimates of change within each group; the between-group comparison is the more direct statistic for the trial question. The overlap between group-specific intervals is not itself a formal test of the treatment contrast.
The confidence interval for the treatment contrast includes effects in either direction. Its interpretation depends on what magnitude of change would be important, and that threshold is not reported in the registry record. The result therefore does not establish a clinically meaningful benefit, harm, or equivalence. The p-value is not the probability that the treatment has no effect; it describes how compatible the observed data are with the tested null model, subject to the analysis assumptions.
The primary analysis is one result at one defined time point. The registry also reports several secondary outcomes across a longer period. Those outcomes address different aspects of function, respiratory events, and related measures, so they do not replace the primary endpoint or provide a single unified estimate of respiratory function. Their interpretation depends on their analysis methods and on how multiple comparisons and missing measurements were handled; those details are not reported in the registry record.
In general, a confidence interval conveys both the direction and precision of an estimate. Here, the interval around the primary contrast spans zero, so the result is compatible with no between-group difference as well as with effects in either direction. No conclusion about the size of an effect that would matter to patients can be made from the registry result alone, because a clinical-importance threshold is not reported.
9. Statistical Methods Explained
What does the primary estimate represent?
The registry reports a least-squares mean change from baseline for each group and an ANCOVA comparison described as a mean difference in final values. A least-squares mean is a model-based group estimate. ANCOVA is a method for comparing an outcome while accounting for specified covariates. Which covariates were included, how baseline values entered the model, and whether any other adjustment terms were used are not reported in the registry record. The estimate of 0.258 is the reported contrast between groups, rather than a separate treatment effect calculated from the two group confidence intervals.
The reported 95% confidence interval extends from -2.032 to 2.547, and the p-value is 0.825. In general, a confidence interval gives a range of values reasonably compatible with the data and the model under repeated use of the same method. It is not a range containing a known fixed proportion of individual outcomes. The interval includes zero, which is the value corresponding to no difference in the contrast. The registry does not report a threshold for clinical importance, so the interval cannot be classified as excluding or including a clinically important effect.
Why distinguish within-group change from the group contrast?
The estimates for levosimendan and placebo describe change in each arm. The trial’s comparative question, however, concerns whether those changes differ between arms. A change within one group can occur for reasons shared by both groups, including the passage of time and study participation. Randomized comparison is intended to separate the treatment-group contrast from such common influences. The reported ANCOVA result is therefore more relevant to the randomized comparison than treating one group’s change as evidence on its own.
In general, adjustment can improve precision or account for baseline imbalance when the model is properly specified. It can also make the result depend on modeling decisions. The registry identifies ANCOVA but does not report enough detail to assess the exact model specification, diagnostic checks, or treatment of departures from model assumptions.
What do the secondary re-calculations add?
Some secondary continuous outcomes include unadjusted re-calculations based on posted summary statistics. These are simple comparisons reconstructed from the reported group estimates and standard errors; they are not substitutes for the sponsor’s model-based analyses. Their intervals and p-values can differ because the re-calculation may not reproduce the original model, covariate adjustment, or handling of incomplete measurements. For the combined assessment of function and survival, the re-calculated contrast is 10.69, with a 95% confidence interval from -23.13 to 44.51 and unadjusted p = 0.536. For the respiratory-function slope outcome, the re-calculated contrast is 0.014, with a 95% confidence interval from -0.038 to 0.066 and unadjusted p = 0.599. These values are exploratory summaries, not a replacement analysis.
The time-to-respiratory-event comparison is reported as a Cox regression hazard ratio. In general, a hazard ratio compares event rates over follow-up as modeled by the method; it is not a direct comparison of median times. The registry reports a hazard ratio of 1.051 with a 95% confidence interval from 0.833 to 1.327 and p = 0.673. The methods and assumptions for the Cox model beyond its identification as regression are not reported in the registry record.
Why does over-dispersion matter?
General statistical explanation: count outcomes can vary more than a simple model assumes. This is called over-dispersion, and ignoring it can make standard errors too small and confidence intervals too narrow. The main posted outcomes are continuous measures and a time-to-event outcome, not a count comparison analyzed with a count model. The registry does not report an over-dispersion analysis, and no such adjustment should be inferred.
What can planning illustrations say?
The planning illustrations use observed effects and assumptions stated in the registry, including a two-sided significance level of 0.05, equal allocation, and a normal approximation. For the time-to-event outcome, the illustrations concern total events; for the other outcomes, they concern participants per arm. These calculations are hypothetical planning aids, not the trial’s sample-size justification and not observed power. The trial’s own design assumptions and sample-size justification are not reported in the registry record. An observed effect can be imprecise or close to zero, so planning around it should not be treated as evidence that the trial had a particular probability of detecting a true effect.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| ANCOVA | Mean Difference (Final Values) 0.258 | -2.032 to 2.547 | 0.825 |
The primary result reported by the registry is the sponsor’s ANCOVA comparison: a mean difference of 0.258, a 95% confidence interval from -2.032 to 2.547, and p = 0.825. The record does not flag a discrepancy for this comparison. The result to interpret for the primary endpoint is therefore the reported ANCOVA analysis, not a reconstructed estimate from separate arm summaries.
For secondary outcomes, the registry includes sponsor analyses and, for some continuous measures, simple unadjusted re-calculations from summary statistics. The combined assessment of function and survival has the same reported point estimate in the sponsor comparison and the re-calculation, but the confidence intervals differ. For the respiratory-function slope, the point estimates are close but not identical, and the intervals and p-values also differ. Such differences are possible because summary-statistic re-calculations do not necessarily reproduce the original model or its handling of data.
The time-to-event result is reported with the same hazard-ratio estimate and interval in the sponsor analysis and the comparison record. No discrepancy is flagged. In general, when a re-calculation differs from the sponsor’s analysis, the sponsor’s own analysis takes precedence for describing the registry result, while the re-calculation remains a limited check based on posted summaries. It should not be interpreted as an independent confirmation.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary endpoint and multiple secondary outcomes. Testing several outcomes can increase the chance of at least one apparently favorable result by chance. In general, multiplicity is addressed through prespecified testing order, adjusted significance thresholds, or other methods suited to the analysis plan. Whether any of these approaches was used is not reported in the registry record. The record also does not report the planned hierarchy of hypotheses or how secondary results were to be interpreted for formal claims.
The primary result is reported with a 95% confidence interval and p-value, but the registry record does not provide the full statistical analysis plan, the prespecified significance level for the primary analysis, or details of any interim analyses. The brief summary says an independent data and safety monitoring board monitored the study; its monitoring procedures and any interim efficacy analyses are not reported in the registry record.
Missing data can affect estimates if participants do not complete visits or measurements. The registry does not report the amount or pattern of missing primary-outcome data, the reasons for missingness, or the methods used to address it. The analysis population and the rule for including participants in each efficacy analysis are also not reported in the registry record. The outcome-specific arm counts should therefore be read as reported counts, not assumed to identify a particular analysis population.
In general, conclusions can depend on whether missing outcomes are handled by a model, imputation, or another method, and on assumptions about why data are missing. Without those details, the robustness of the primary and secondary estimates to incomplete follow-up cannot be assessed from the registry record. The record does not report sensitivity analyses designed to test alternative assumptions about missing data.
The registry describes treatment for 48 weeks and a primary endpoint at 12 weeks, but does not give the detailed endpoint-specific analysis rules or the planned handling of protocol deviations. These omissions limit assessment of how closely the posted analyses follow the original plan and how the reported populations relate to all randomized participants.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Levosimendan | 89 | 326 | 27.3% |
| Placebo for Levosimendan | 45 | 166 | 27.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Levosimendan | 27 of 326 |
| Placebo for Levosimendan | 17 of 166 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 4% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Levosimendan | 312 of 326 |
| Placebo for Levosimendan | 157 of 166 |
Most frequent serious adverse event terms
| Event term | Organ system | Levosimendan | Placebo for Levosimendan |
|---|---|---|---|
| Pneumonia | Infections and infestations | 12 of 326 | 7 of 166 |
| Fall | Injury, poisoning and procedural complications | 13 of 326 | 6 of 166 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 13 of 326 | 5 of 166 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 9 of 326 | 4 of 166 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 7 of 326 | 3 of 166 |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | 8 of 326 | 2 of 166 |
| Amyotrophic lateral sclerosis | Nervous system disorders | 4 of 326 | 3 of 166 |
| Urinary tract infection | Infections and infestations | 1 of 326 | 5 of 166 |
| Chest pain | General disorders | 4 of 326 | 1 of 166 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 2 of 326 | 2 of 166 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Levosimendan | Placebo for Levosimendan |
|---|---|---|---|
| Headache | Nervous system disorders | 101 of 326 | 36 of 166 |
| Fall | Injury, poisoning and procedural complications | 86 of 326 | 45 of 166 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 54 of 326 | 30 of 166 |
| Nasopharyngitis | Infections and infestations | 52 of 326 | 26 of 166 |
| Dysphagia | Gastrointestinal disorders | 47 of 326 | 27 of 166 |
| Heart rate increased | Investigations | 64 of 326 | 5 of 166 |
| Constipation | Gastrointestinal disorders | 38 of 326 | 21 of 166 |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 31 of 326 | 18 of 166 |
| Nausea | Gastrointestinal disorders | 29 of 326 | 15 of 166 |
| Urinary tract infection | Infections and infestations | 25 of 326 | 17 of 166 |
Serious events with the highest arm-level rate: pneumonia (4.2%), fall (4.0%), respiratory failure (4.0%), urinary tract infection (3.0%), pulmonary embolism (2.8%).
The registry reports serious adverse events for 89 of 326 participants at risk in the levosimendan group and 45 of 166 participants at risk in the placebo group. It also reports other adverse events for 312 of 326 and 157 of 166 participants at risk, respectively. These are counts within the recorded safety groups; they should not be confused with the arm counts attached to the primary efficacy outcome.
Deaths are reported as 27 in the levosimendan group and 17 in the placebo group. The registry figures do not establish whether an event was caused by study treatment. A causal safety comparison would require details about event definitions, follow-up, exposure, ascertainment, and the analysis approach; those details are not reported in the registry record.
The registry lists serious-event terms with percentages, including pneumonia, fall, respiratory failure, urinary tract infection, pulmonary embolism, and pneumonia aspiration. The denominator and the specific basis for those percentages are not reported in the registry record, so they should not be treated as arm-specific rates. Counts and listed terms describe reported events; they do not by themselves establish comparative risk or causation.
13. What the Result Does, and Does Not, Mean
The primary result describes a comparison of change in supine SVC at 12 weeks between randomized groups. The estimated difference is close to zero, and its 95% confidence interval includes zero. The reported p-value does not provide evidence of a statistically established group difference under the reported ANCOVA analysis. That is a statement about the evidence from this endpoint and analysis, not proof that the treatments have exactly the same effect.
Nor does the result establish that any possible difference is clinically unimportant. The registry record does not report a threshold for a meaningful SVC change, and the confidence interval spans values on both sides of zero. The result therefore does not demonstrate equivalence or exclude all potentially important effects. Such claims require an appropriate design and prespecified margins, which are not reported in the registry record.
The primary result also does not answer every question about function, survival, respiratory events, symptoms, or safety. Those outcomes were assessed separately, with different scales and time frames. Their interpretation depends on their own models, missing-data handling, and multiplicity procedures, details that are not fully reported in the registry record.
In general, randomized comparisons are intended to estimate differences between assigned groups, while the observed results remain subject to sampling variability and analysis assumptions. The registry’s posted estimates are not individual predictions and do not establish what will happen to any particular person. They should be read as trial-level statistical evidence, with the uncertainty and reporting limitations.
The data also do not establish that levosimendan works or does not work overall. They show the reported estimates for a specified primary respiratory-function endpoint and selected secondary and safety outcomes. Broader conclusions would require a complete assessment of the trial protocol, analysis plan, full results, and relevant clinical context; several of those details are not reported in the registry record.
14. Why This Trial Matters Statistically
This trial illustrates why the treatment contrast, rather than the within-group changes alone, is central to interpreting a randomized study. Both arms had reported changes in supine SVC, but the primary question is whether the groups differed. The ANCOVA contrast directly addresses that question and is accompanied by an interval that conveys uncertainty.
It also illustrates the distinction between a result that is not statistically established and proof of no effect. The confidence interval crosses zero, while the registry does not report a clinical-importance threshold. A reader can therefore understand the statistical uncertainty without treating a non-significant result as evidence of equivalence.
The trial’s multiple secondary measures show why outcome selection and multiplicity matter. Function, respiratory events, and other measures may each provide useful context, but they are not interchangeable. Without a reported testing hierarchy or multiplicity procedure, isolated secondary findings would require particular caution.
Finally, the registry allows a comparison between sponsor analyses and limited summary-statistic re-calculations. Those re-calculations can help readers see how much conclusions depend on model-based methods, but they cannot reproduce all aspects of the sponsor’s analysis. Missing-data methods, analysis populations, and detailed model specifications are not reported in the registry record. Those gaps matter because statistical estimates are shaped not only by observed values but also by how the analysis is defined.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record does not report the eligibility criteria or baseline characteristics needed to assess how closely the enrolled population represents any broader population. It also does not provide the full protocol or statistical analysis plan, so the prespecification of analysis choices and outcomes cannot be evaluated from the record alone.
For the primary ANCOVA, the registry does not identify the covariates, model diagnostics, or exact analysis population. It does not report the extent or pattern of missing primary measurements, the method used to address missingness, or sensitivity analyses. These omissions limit assessment of the assumptions behind the estimate and its robustness to incomplete data.
The record lists several secondary outcomes but does not report whether multiplicity was controlled, how secondary hypotheses were ordered, or whether interim analyses were performed. The brief summary notes oversight by an independent data and safety monitoring board, but does not describe its procedures. This restricts interpretation of secondary p-values and the trial’s monitoring history.
The safety results are presented as counts and selected event terms, but the registry record does not provide full event-level descriptions, exposure-adjusted analyses, or enough detail to assess causality. The denominators for the listed serious-event percentages are not reported in the registry record. The counts should therefore be read descriptively rather than as a complete comparative safety analysis.
Lastly, the primary endpoint concerns supine SVC at 12 weeks, whereas treatment duration was 48 weeks and other outcomes addressed later follow-up or different domains. The primary result alone cannot characterize all longer-term outcomes. The registry record also does not report a threshold defining a clinically important SVC difference, limiting the clinical interpretation of the confidence interval.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS — NCT03505021.
- Registry record last updated 2022-05-11; status last verified 2022-04.
- Results first posted 2021-08-31.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
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19. Record Summary
The registry describes a completed phase 3 randomized parallel-group trial of oral levosimendan versus placebo in amyotrophic lateral sclerosis. Enrollment was 496, with treatment described as lasting 48 weeks and allocation described as 2:1. The primary endpoint was change from baseline in supine SVC, expressed as a percentage of predicted normal, at 12 weeks.
The reported ANCOVA comparison estimated a mean difference of 0.258, with a 95% confidence interval from -2.032 to 2.547 and p = 0.825. The interval includes zero, and the registry does not report a clinical-importance threshold. Secondary outcomes cover function, respiratory events, and related measures; serious adverse event counts are also recorded.
Important details about the analysis plan, missing-data handling, analysis populations, and multiplicity procedures are not reported in the registry record. Those limits should inform interpretation of both the primary result and the broader set of posted outcomes.