Trial · NCT03505021

Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS

NCT03505021, Phase 3, Completed, Orion Corporation, Orion Pharma; results first posted 2021-08-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS. Trials, record NCT03505021. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03505021

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS
NCT number: NCT03505021
Status: Completed
Phases: Phase 3
Enrollment: 496 participants, actual
Lead sponsor: Orion Corporation, Orion Pharma
Conditions: Amyotrophic Lateral Sclerosis
Interventions: Levosimendan, Placebo for levosimendan
First posted: 2018-04-20
Last updated: 2022-05-11
Results first posted: 2021-08-31

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Supine Slow Vital Capacity (SVC)	The change from baseline at 12 weeks	Change from baseline to 12 weeks, expressed as % of predicted normal.
Secondary	Combined Assessment of Function and Survival Through 48 Weeks	Mean rank at 48 weeks	Scale: The ALS Functional Rating Scale - Revised. This scale includes 12 items. Each item was scored from 0 to 4. Total score is the sum of the scores of all 12 items. Each subject is ranked according to time-to-death (earlier deaths ranked lower than later deaths). Subjects who survive are ranked more favorably than subjects who died. Among the survivors, subjects are ranked according to change in ALSFRS-R (greater worsening of ALSFRS-R is ranked lower than after deaths). Subjects who survive are ranked more favorably than subjects who died. Among the survivors, subjects are ranked according to change in ALSFRS-R (greater worsening of ALSFRS-R is ranked lower than less worsening or an improvement in ALSFRS-R). The ranked scores range from 001 to 496 (the number of participants assessed for the Outcome Measure) with larger rank score numbers associated with a better outcome.
Secondary	Time to Respiratory Event Through 48 Weeks	Time to event through 48 weeks	ALSFRS-R scale contains 3 items that relate to respiratory function: severity of dyspnoea, occurrence of orthopnoea (shortness of breath when lying flat) and the use of mechanical ventilation for respiratory insufficiency. A reduction in any one of these items was considered a respiratory event. Not all patients receive ventilatory support, despite respiratory insufficiency: meeting "protocolised" criteria for NIV relates to patients without NIV whose slow vital capacity declined to a level that would ordinarily trigger such treatment.
Secondary	Change From the Baseline in Clinical Global Impression CGI at 48 Weeks	The change from baseline at 48 weeks	Visual Analogue Scale 0-100 millimeters, rated by study subjects. Score 0 indicates that the subject is completely well without any disability and score 100 indicates the worst possible severity of the condition.
Secondary	Change From Baseline in Respiratory Function of ALSFRS-R at 48 Weeks	Slope of decline at 48 weeks	ALSFRS-R scale contains 3 items that relate to respiratory function: severity of dyspnoea, occurrence of orthopnoea (shortness of breath when lying flat) and the use of mechanical ventilation for respiratory insufficiency. These are added together to created the respiratory domain with a score range 0-12 (where 12 represents 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 to reduce the slope of decline.
Secondary	Supine Borg Category Ratio 10 Scale at 12 Weeks	Change from baseline at 12 weeks	Patients rated their perception of the severity of their dysnoea using the Borg scale. The scale ranges from 0 (no dyspnoea) to 10 (maximal). Each category is numbered and most (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 at 12 weeks, where a negative score indicates improvement and a positive score reflects worsening.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Supine Slow Vital Capacity (SVC)	The change from baseline at 12 weeks	percentage	LEAST_SQUARES_MEAN
SECONDARY	Combined Assessment of Function and Survival Through 48 Weeks	Mean rank at 48 weeks	Scores on a rank scale	LEAST_SQUARES_MEAN
SECONDARY	Time to Respiratory Event Through 48 Weeks	Time to event through 48 weeks	Days	MEDIAN
SECONDARY	Change From the Baseline in Clinical Global Impression CGI at 48 Weeks	The change from baseline at 48 weeks	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Respiratory Function of ALSFRS-R at 48 Weeks	Slope of decline at 48 weeks	Score on a scale/month	LEAST_SQUARES_MEAN
SECONDARY	Supine Borg Category Ratio 10 Scale at 12 Weeks	Change from baseline at 12 weeks	score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Supine Slow Vital Capacity (SVC)	Levosimendan	-6.731	95% Confidence Interval -8.290 to -5.171	percentage
Supine Slow Vital Capacity (SVC)	Placebo for Levosimendan	-6.988	95% Confidence Interval -9.052 to -4.925	percentage
Combined Assessment of Function and Survival Through 48 Weeks	Levosimendan	239.85	Standard Error 10.98	Scores on a rank scale
Combined Assessment of Function and Survival Through 48 Weeks	Placebo for Levosimendan	229.16	Standard Error 13.31	Scores on a rank scale
Time to Respiratory Event Through 48 Weeks	Levosimendan	90	95% Confidence Interval 82 to 144	Days
Time to Respiratory Event Through 48 Weeks	Placebo for Levosimendan	126	95% Confidence Interval 82 to 169	Days
Change From the Baseline in Clinical Global Impression CGI at 48 Weeks	Levosimendan	17.048	95% Confidence Interval 14.111 to 19.984	units on a scale
Change From the Baseline in Clinical Global Impression CGI at 48 Weeks	Placebo for Levosimendan	13.285	95% Confidence Interval 9.252 to 17.318	units on a scale
Change From Baseline in Respiratory Function of ALSFRS-R at 48 Weeks	Levosimendan	-0.191	Standard Error 0.015	Score on a scale/month
Change From Baseline in Respiratory Function of ALSFRS-R at 48 Weeks	Placebo for Levosimendan	-0.205	Standard Error 0.022	Score on a scale/month

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Levosimendan	329
Overall Study	STARTED	Placebo for Levosimendan	167
Overall Study	COMPLETED	Levosimendan	217
Overall Study	COMPLETED	Placebo for Levosimendan	112
Overall Study	NOT COMPLETED	Levosimendan	112
Overall Study	NOT COMPLETED	Placebo for Levosimendan	55

Source ClinicalTrials.gov

Adverse events328

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	Palpitations	Cardiac disorders	Levosimendan	17	326	23
other	Palpitations	Cardiac disorders	Placebo for Levosimendan	4	166	4
other	Sinus tachycardia	Cardiac disorders	Levosimendan	13	326	14
other	Sinus tachycardia	Cardiac disorders	Placebo for Levosimendan	0	166	0
other	Tachycardia	Cardiac disorders	Levosimendan	32	326	41
other	Tachycardia	Cardiac disorders	Placebo for Levosimendan	8	166	11
other	Abdominal pain	Gastrointestinal disorders	Levosimendan	12	326	13
other	Abdominal pain	Gastrointestinal disorders	Placebo for Levosimendan	2	166	2
other	Constipation	Gastrointestinal disorders	Levosimendan	38	326	41
other	Constipation	Gastrointestinal disorders	Placebo for Levosimendan	21	166	22

1 to 10 of 328Source ClinicalTrials.gov

See all 328 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Levosimendan	27	326
Total, all-cause mortality	Placebo for Levosimendan	17	166
Total, other adverse events	Levosimendan	312	326
Total, other adverse events	Placebo for Levosimendan	157	166
Total, serious adverse events	Levosimendan	89	326
Total, serious adverse events	Placebo for Levosimendan	45	166

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Levosimendan vs Placebo for Levosimendan: deaths from any cause	Trial comparisons
Levosimendan vs Placebo for Levosimendan: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03505021

GET https://conductscience.org/api/trials/v1/NCT03505021/events?page=2

API reference For AI assistants