Trial · NCT04944784
A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)
NCT04944784, Phase 3, Terminated, Cytokinetics; results first posted 2024-12-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS). Trials, record NCT04944784. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04944784
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)
- NCT number
- NCT04944784
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 489 participants, actual
- Lead sponsor
- Cytokinetics
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- Reldesemtiv, Placebo
- First posted
- 2021-06-30
- Last updated
- 2024-12-05
- Other registries' IDs
- eudract:2020-004040-29
- Results first posted
- 2024-12-05
- Limitations and caveats
- The Data Monitoring Committee reviewed unblinded data at the second planned interim analysis and recommended discontinuation of the clinical trial due to futility.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effect of Reldesemtiv Versus Placebo on Functional Outcomes in Amyotrophic Lateral Sclerosis (ALS) | Baseline to Week 24 | Change from baseline to Week 24 in Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total score using MMRM without multiple imputation; rating scale 0 to 48; higher scores indicate better functional status |
| Secondary | Effect of Reldesemtiv Versus Placebo on Combined Functional and Survival Outcomes in Amyotrophic Lateral Sclerosis (ALS) | Baseline to Week 24 | Composite Assessment of Function and Survival (CAFS) compares ranked outcomes based on change from baseline in ALS Functional Rating Scale-Revised (ALSFRS-R) score (0-48; higher scores indicate better function), time in months to dependence on assisted ventilation (DOAV) and time in months to death. Deceased participants are ranked by time-to-death; earliest deaths ranked the lowest. DOAV survivors are ranked more favorably than those who have died but lower than those alive and not DOAV. Non-DOAV survivors are ranked based on change in ALSFRS-R (largest decline in ALSFRS-R ranked lower than less decline or improvement in ALSFRS-R). Unitless ranked scores range from 1-482 (Full Analysis Set) with larger rank scores associated with a better outcome. Ranks were analyzed using stratified Wilcoxon test comparing the ranked scores between reldesemtiv and placebo, adjusting for baseline riluzole and edaravone use. The win probability and the ratio (reldesemtiv vs placebo) are presented. |
| Secondary | Effect of Reldesemtiv Versus Placebo on Ventilatory Function | Baseline to Week 24 | Change from baseline in percent predicted forced vital capacity (FVC) using an in-clinic spirometer; a negative number for change from baseline indicates respiratory function decline relative to baseline |
| Secondary | Effect of Reldesemtiv Versus Placebo on Quality of Life | Baseline to Week 24 | Change from baseline in ALSAQ-40 total score. ALSAQ-40 = Amyotrophic Lateral Sclerosis Assessment Questionnaire; summary scores range from 0 (best health status) to 100 (worst health status); ALSAQ-40 total score is calculated as the sum of the summary scores from the 5 domains; lower score corresponds to better health-related quality of life. |
| Secondary | Effect of Reldesemtiv Versus Placebo on Handgrip Strength | Baseline to Week 24 | Change from baseline in maximum handgrip strength (average of both hands) measured bilaterally by an electronic hand dynamometer |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Effect of Reldesemtiv Versus Placebo on Functional Outcomes in Amyotrophic Lateral Sclerosis (ALS) | Baseline to Week 24 | Full Analysis Set | score on a scale | MEAN |
| SECONDARY | Effect of Reldesemtiv Versus Placebo on Combined Functional and Survival Outcomes in Amyotrophic Lateral Sclerosis (ALS) | Baseline to Week 24 | Full Analysis Set | unitless | MEDIAN |
| SECONDARY | Effect of Reldesemtiv Versus Placebo on Ventilatory Function | Baseline to Week 24 | Full Analysis Set | percent predicted | MEAN |
| SECONDARY | Effect of Reldesemtiv Versus Placebo on Quality of Life | Baseline to Week 24 | Full Analysis Set | score on a scale | MEAN |
| SECONDARY | Effect of Reldesemtiv Versus Placebo on Handgrip Strength | Baseline to Week 24 | Full Analysis Set | pounds | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Effect of Reldesemtiv Versus Placebo on Functional Outcomes in Amyotrophic Lateral Sclerosis (ALS) | Reldesemtiv Group, Double-Blind Period | -5.57 | Standard Deviation 5.307 | score on a scale | |
| Effect of Reldesemtiv Versus Placebo on Functional Outcomes in Amyotrophic Lateral Sclerosis (ALS) | Placebo Group, Double-Blind Period | -4.76 | Standard Deviation 4.420 | score on a scale | |
| Effect of Reldesemtiv Versus Placebo on Combined Functional and Survival Outcomes in Amyotrophic Lateral Sclerosis (ALS) | Reldesemtiv Group, Double-Blind Period | 232.5 | 95% Confidence Interval 211.0 to 257.0 | unitless | |
| Effect of Reldesemtiv Versus Placebo on Combined Functional and Survival Outcomes in Amyotrophic Lateral Sclerosis (ALS) | Placebo Group, Double-Blind Period | 264.0 | 95% Confidence Interval 209.0 to 291.0 | unitless | |
| Effect of Reldesemtiv Versus Placebo on Ventilatory Function | Reldesemtiv Group, Double-Blind Period | -10.562 | Standard Deviation 12.8178 | percent predicted | |
| Effect of Reldesemtiv Versus Placebo on Ventilatory Function | Placebo Group, Double-Blind Period | -9.677 | Standard Deviation 13.1073 | percent predicted | |
| Effect of Reldesemtiv Versus Placebo on Quality of Life | Reldesemtiv Group, Double-Blind Period | 11.426 | Standard Deviation 12.2102 | score on a scale | |
| Effect of Reldesemtiv Versus Placebo on Quality of Life | Placebo Group, Double-Blind Period | 9.766 | Standard Deviation 11.3662 | score on a scale | |
| Effect of Reldesemtiv Versus Placebo on Handgrip Strength | Reldesemtiv Group, Double-Blind Period | -10.134 | Standard Deviation 9.6821 | pounds | |
| Effect of Reldesemtiv Versus Placebo on Handgrip Strength | Placebo Group, Double-Blind Period | -7.370 | Standard Deviation 9.7733 | pounds |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Period | STARTED | Reldesemtiv Group, Double-Blind Period | 325 | |
| Double-blind Period | STARTED | Placebo Group, Double-Blind Period | 161 | |
| Double-blind Period | STARTED | Delayed Start Group, Active Drug Period | 0 | |
| Double-blind Period | STARTED | Early Start Group, Active Drug Period | 0 | |
| Double-blind Period | COMPLETED | Reldesemtiv Group, Double-Blind Period | 180 | |
| Double-blind Period | COMPLETED | Placebo Group, Double-Blind Period | 96 | |
| Double-blind Period | COMPLETED | Delayed Start Group, Active Drug Period | 0 | |
| Double-blind Period | COMPLETED | Early Start Group, Active Drug Period | 0 | |
| Double-blind Period | NOT COMPLETED | Reldesemtiv Group, Double-Blind Period | 145 | |
| Double-blind Period | NOT COMPLETED | Placebo Group, Double-Blind Period | 65 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events380
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 | COVID-19 | Infections and infestations | Reldesemtiv Group, Double-Blind Period | 30 | 325 | 30 |
| other | COVID-19 | Infections and infestations | Placebo Group, Double-Blind Period | 13 | 161 | 13 |
| other | COVID-19 | Infections and infestations | Delayed Start Group, Active Drug Period | 8 | 96 | 8 |
| other | COVID-19 | Infections and infestations | Early Start Group, Active Drug Period | 12 | 180 | 12 |
| other | urinary tract infection | Infections and infestations | Reldesemtiv Group, Double-Blind Period | 20 | 325 | 20 |
| other | urinary tract infection | Infections and infestations | Placebo Group, Double-Blind Period | 9 | 161 | 9 |
| other | urinary tract infection | Infections and infestations | Delayed Start Group, Active Drug Period | 6 | 96 | 6 |
| other | urinary tract infection | Infections and infestations | Early Start Group, Active Drug Period | 13 | 180 | 13 |
| other | nasopharyngitis | Infections and infestations | Reldesemtiv Group, Double-Blind Period | 17 | 325 | 17 |
| other | nasopharyngitis | Infections and infestations | Placebo Group, Double-Blind Period | 6 | 161 | 6 |
1 to 10 of 380Source ClinicalTrials.gov
See all 380 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Reldesemtiv Group, Double-Blind Period | 9 | 325 |
| Total, all-cause mortality | Placebo Group, Double-Blind Period | 6 | 161 |
| Total, all-cause mortality | Delayed Start Group, Active Drug Period | 5 | 96 |
| Total, all-cause mortality | Early Start Group, Active Drug Period | 8 | 180 |
| Total, other adverse events | Reldesemtiv Group, Double-Blind Period | 258 | 325 |
| Total, other adverse events | Placebo Group, Double-Blind Period | 125 | 161 |
| Total, other adverse events | Delayed Start Group, Active Drug Period | 65 | 96 |
| Total, other adverse events | Early Start Group, Active Drug Period | 122 | 180 |
| Total, serious adverse events | Reldesemtiv Group, Double-Blind Period | 41 | 325 |
| Total, serious adverse events | Placebo Group, Double-Blind Period | 25 | 161 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
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/NCT04944784
GET https://conductscience.org/api/trials/v1/NCT04944784/flow?page=2