Trial · NCT03948178
Effects of Oral Levosimendan on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis (ALS): Open-Label Extension
NCT03948178, Phase 3, Terminated, Orion Corporation, Orion Pharma; results first posted 2023-03-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effects of Oral Levosimendan on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis (ALS): Open-Label Extension. Trials, record NCT03948178. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03948178
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Oral Levosimendan on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis (ALS): Open-Label Extension
- NCT number
- NCT03948178
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 227 participants, actual
- Lead sponsor
- Orion Corporation, Orion Pharma
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- Levosimendan
- First posted
- 2019-05-13
- Last updated
- 2023-03-09
- Results first posted
- 2023-03-09
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse Events Recording | From signing informed consent until 14-25 days after the last study treatment for all patients, an average of 23.5 weeks. | Adverse Events as subject counts and proportions (%) of subject per Adverse Event |
| Primary | Pulse/Heart Rate Assessment | Change in pulse and heart rate(from ECG recording) from Baseline, week 2, week 4, week 6 (pulse rate only), Month 3, Month 6, end of study (subject's last visit, 2-48 weeks after study entry) | Actual values and changes from baseline in supine pre-dose pulse/heart rate were summarised using descriptive statistics . |
| Primary | 12-lead Electrocardiogram Assessments | Baseline, week 2, week 4, month 3, month 6, end-of-study(subject's last visit, 2-48 weeks after study entry) | Summarisation of any abnormal 12-lead ECG findings using descriptive statistics. |
| Secondary | Disease Progression | From Baseline through study completion(subject's last visit, 2-48 weeks after study entry) | Count of study withdrawals due to disease progression |
| Secondary | Supine Slow Vital Capacity (SVC) | The change from Baseline, week 2, week 4, month 3, month 6, end-of-study (subject's last visit, 2-48 weeks after study entry) | Change from baseline in supine and sitting SVC (all devices) through to the end of the study, expressed as a % of predicted normal |
| Secondary | Revised ALS Functional Rating Scale (ALSFRS-R) | Change from Baseline in respiratory function of ALSFRS-R at study completion (subject's last visit, 2-48 weeks after study entry) | ALSFRS-R scale contains 3 parameters related to respiratory function: Severity of dyspnea, occurrence of orthopnea (shortness of breath when in supine position i.e. lying flat), and the use of mechanical ventilation for respiratory in sufficiency. These 3 parameters are combined to create the respiratory domain with a score of 0-12(where 12 is normal function). Although individual items and patients vary, ALSFRS-R typically declines at a relatively constant rate over time. Plotted over time the slope of the line obtained indicates the speed of progression and thus an effective treatment might be expected ro reduce the slope of decline. |
| Secondary | Need for Respiratory Support Device | Time to event at study completion (subject's last visit, 2-48 weeks after study entry) | Time to respiratory device support (non invasive) or death |
| Secondary | Borg Category Ratio 10 Scale (CR 10) | Baseline through study completion (week 2, week 4, month 3, month 6, end of study (subject's last visit, 2-48 weeks after study entry) | Patients rated their perception of the severity of their dyspnea using the Borg Category Ration 10 scale (CR 10). The scale ranges from 0(no dysponea) to 10 (maximal dyspnea). each category is numbered and most but not all have verbal cues. At each assessment the patient scored the category they felt best described their symptoms. The analysis measured change from baseline to the end of the study in both a supine and sitting position where a negative score indicates improvement and a positive score reflects worsening. |
| Secondary | Number of Subjects Requiring Health and Home Care Resource Use | Baseline through study completion (2- 48 weeks after study entry) | The number of study subjects requiring Health and home care resource use was aggregated over the course of the study for each subject and summarised using descriptive statistics. |
| Secondary | Subject's Status for Tracheostomy and Survival | Baseline to end of study (average 2-48 weeks after study entry | Number of patients with the need for tracheostomy or who died whilst on treatment from baseline to the end of the study was summarised using descriptive statistics. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adverse Events Recording | From signing informed consent until 14-25 days after the last study treatment for all patients, an average of 23.5 weeks. | Analysis is reported for the safety population which included all subjects receiving any study treatment. Treatment emergent AEs are defined as any event arising or worsening after the start of study treatment until 25 days after the individual subject's last study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Pulse/Heart Rate Assessment | Change in pulse and heart rate(from ECG recording) from Baseline, week 2, week 4, week 6 (pulse rate only), Month 3, Month 6, end of study (subject's last visit, 2-48 weeks after study entry) | Analysis was performed on the safety population which included all patients who had received at least one dose of study treatment. The change from baseline in pulse and heart rate was measured at week 2, week 4, week 6 (pulse rate only) Month 3, Month 6 and the individual subject 's last visit in the study. The number of subjects analysed at each timepoint differs from the total number of subjects that entered the study as some study subjects did not undergo the assessment at all timepoints. | beats per minute (bpm) | MEAN |
| PRIMARY | 12-lead Electrocardiogram Assessments | Baseline, week 2, week 4, month 3, month 6, end-of-study(subject's last visit, 2-48 weeks after study entry) | Analysis of patients in the safety population defined as all patients who had received at least one dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Progression | From Baseline through study completion(subject's last visit, 2-48 weeks after study entry) | Number of study withdrawals due to disease progression were collected for all subjects entered into the study. The study sponsor terminated the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Supine Slow Vital Capacity (SVC) | The change from Baseline, week 2, week 4, month 3, month 6, end-of-study (subject's last visit, 2-48 weeks after study entry) | Analysis was performed on the safety population which included all patients who had received at least one dose of study treatment. The change from baseline in pulse and heart rate was measured at week 2, week 4, week 6 (pulse rate only) Month 3, Month 6 and the individual subject 's last visit in the study. The number of subjects analysed at each timepoint differs from the total number of subjects that entered the study as some study subjects did not undergo the assessment at all timepoints. | % of predicted normal | MEAN |
| SECONDARY | Revised ALS Functional Rating Scale (ALSFRS-R) | Change from Baseline in respiratory function of ALSFRS-R at study completion (subject's last visit, 2-48 weeks after study entry) | Analysis was performed on the safety population which included all patients who had received at least one dose of study treatment. The change from baseline in pulse and heart rate was measured at week 2, week 4, week 6 (pulse rate only) Month 3, Month 6 and the individual subject 's last visit in the study. The number of subjects analysed at each timepoint differs from the total number of subjects that entered the study as some study subjects did not undergo the assessment at all timepoints. | Score on a scale | MEAN |
| SECONDARY | Need for Respiratory Support Device | Time to event at study completion (subject's last visit, 2-48 weeks after study entry) | Analyses were performed in the safety population in which all subjects received at least one dose of study treatment | days | MEAN |
| SECONDARY | Borg Category Ratio 10 Scale (CR 10) | Baseline through study completion (week 2, week 4, month 3, month 6, end of study (subject's last visit, 2-48 weeks after study entry) | Analysis was performed on the safety population which included all patients who had received at least one dose of study treatment. The change from baseline in pulse and heart rate was measured at week 2, week 4, week 6 (pulse rate only) Month 3, Month 6 and the individual subject 's last visit in the study. The number of subjects analysed at each timepoint differs from the total number of subjects that entered the study as some study subjects did not undergo the assessment at all timepoints. | units on a scale | MEAN |
| SECONDARY | Number of Subjects Requiring Health and Home Care Resource Use | Baseline through study completion (2- 48 weeks after study entry) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Subject's Status for Tracheostomy and Survival | Baseline to end of study (average 2-48 weeks after study entry | Analysis was performed on the safety population which includes all subjects receiving at least one dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group55
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adverse Events Recording | Levosimendan | 161 | Participants | ||
| Pulse/Heart Rate Assessment | Levosimendan | Change in pulse rate at week 2 | 7.0 | Standard Deviation 8.8 | beats per minute (bpm) |
| Pulse/Heart Rate Assessment | Levosimendan | Change in pulse rate at 4 weeks | 10.0 | Standard Deviation 10.4 | beats per minute (bpm) |
| Pulse/Heart Rate Assessment | Levosimendan | Change in pulse rate at week 6 | 8.5 | Standard Deviation 12.0 | beats per minute (bpm) |
| Pulse/Heart Rate Assessment | Levosimendan | chnage in pulse rate at Month 3 | 10.4 | Standard Deviation 10.6 | beats per minute (bpm) |
| Pulse/Heart Rate Assessment | Levosimendan | Change in pulse rate at month 6 | 12.8 | Standard Deviation 10.6 | beats per minute (bpm) |
| Pulse/Heart Rate Assessment | Levosimendan | Change in pulse rate at end-of-study | 3.5 | Standard Deviation 12.6 | beats per minute (bpm) |
| Pulse/Heart Rate Assessment | Levosimendan | Change in Heart rate at week 2 | 9.1 | Standard Deviation 10.1 | beats per minute (bpm) |
| Pulse/Heart Rate Assessment | Levosimendan | Change in Heart rate at week 4 | 12.8 | Standard Deviation 9.4 | beats per minute (bpm) |
| Pulse/Heart Rate Assessment | Levosimendan | Change in heart rate at Month 3 | 12.6 | Standard Deviation 9.3 | beats per minute (bpm) |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Levosimendan | 227 | |
| Overall Study | COMPLETED | Levosimendan | 0 | |
| Overall Study | NOT COMPLETED | Levosimendan | 227 |
Source ClinicalTrials.gov
Adverse events64
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fall | Injury, poisoning and procedural complications | Levosimendan | 25 | 227 | 42 |
| other | Headache | Nervous system disorders | Levosimendan | 20 | 227 | 28 |
| other | Tachycardia | Cardiac disorders | Levosimendan | 18 | 227 | 20 |
| other | Dysponea | Respiratory, thoracic and mediastinal disorders | Levosimendan | 14 | 227 | 15 |
| other | Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Levosimendan | 13 | 227 | 13 |
| other | Heart Rate Increased | Investigations | Levosimendan | 12 | 227 | 12 |
| other | Dysphagia | Gastrointestinal disorders | Levosimendan | 11 | 227 | 11 |
| other | Constipation | Gastrointestinal disorders | Levosimendan | 10 | 227 | 11 |
| other | Nasopharyngitis | Infections and infestations | Levosimendan | 10 | 227 | 11 |
| other | Diarrhoea | Gastrointestinal disorders | Levosimendan | 9 | 227 | 9 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Levosimendan | 19 | 227 |
| Total, other adverse events | Levosimendan | 215 | 227 |
| Total, serious adverse events | Levosimendan | 44 | 227 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34536404 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03948178
GET https://conductscience.org/api/trials/v1/NCT03948178/results?page=2