Trial · NCT03160898
A Study to Evaluate Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS)
NCT03160898, Phase 2, Completed, Cytokinetics; results first posted 2020-09-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS). Trials, record NCT03160898. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03160898
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS)
- NCT number
- NCT03160898
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 458 participants, actual
- Lead sponsor
- Cytokinetics
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- Reldesemtiv, Placebo
- First posted
- 2017-05-19
- Last updated
- 2020-09-11
- Results first posted
- 2020-09-11
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 12 in the Percent Predicted Slow Vital Capacity (SVC) | Baseline to Week 12 | Slow vital capacity was measured using a spirometer (in units of liters). Following 3 to 5 breaths at rest, patients were instructed to take as deep an inspiration as possible followed by a maximum exhalation (blowing out all the air in their lungs). Values obtained were converted to percent predicted values using the Global Lung Initiative equation (ie, the test result as a percent of predicted values for patients of similar demographic and baseline characteristics \[eg, height, age, sex\]). |
| Secondary | Change From Baseline to Week 12 in the ALS Functional Rating Scale - Revised (ALSFRS-R) Total Score | Baseline to Week 12 | The ALSFRS-R is used to measure the progression and severity of disability in patients with ALS. The ALSFRS-R consists of 12 questions, assessing a patient's capability and independence in functional activities relevant to ALS, categorized in the following 4 domains: gross motor tasks, fine motor tasks, bulbar functions, and respiratory function. Each question is scored from 0 (indicating incapable or dependent) to 4 (normal). The total score ranges from 0 to 48. Higher scores reflect more normal function and lower scores reflect more impaired function. |
| Secondary | Slope of Muscle Strength Mega-score From Baseline to Week 12 | Baseline to Week 12 | A hand-held dynamometer, with a scale of 0 to 300 pounds, was used to measure muscle strength and handgrip strength (bilateral). The muscle groups tested were: elbow flexion, wrist extension, first dorsal interosseous, hip flexion, knee extension, and ankle dorsiflexion; all muscle groups were evaluated bilaterally. For each postbaseline assessment of muscle strength, the percent change from baseline was calculated for each muscle group and handgrip strength, using the following equation: (\[postbaseline value - baseline value\] / baseline value) × 100. The muscle-strength mega-score was calculated as the average of the changes (ie, percent change from baseline) observed for each of the muscle groups as well as handgrip strength. For this endpoint, negative values indicate a decline in muscle strength. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 12 in the Percent Predicted Slow Vital Capacity (SVC) | Baseline to Week 12 | The outcome measure was analyzed for the Full Analysis Set, which consisted of all randomized patients who received any amount of study drug and had a baseline and at least 1 postbaseline efficacy assessment during double-blind treatment. | percent predicted | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 12 in the ALS Functional Rating Scale - Revised (ALSFRS-R) Total Score | Baseline to Week 12 | The outcome measure was analyzed for the Full Analysis Set, which consisted of all randomized patients who received any amount of study drug and had a baseline and at least 1 postbaseline efficacy assessment during double-blind treatment. | change in score | LEAST_SQUARES_MEAN |
| SECONDARY | Slope of Muscle Strength Mega-score From Baseline to Week 12 | Baseline to Week 12 | The outcome measure was analyzed for the Full Analysis Set, which consisted of all randomized patients who received any amount of study drug and had a baseline and at least 1 postbaseline efficacy assessment during double-blind treatment. | change in mega-score per day | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 12 in the Percent Predicted Slow Vital Capacity (SVC) | Placebo | -6.46 | Standard Error 0.964 | percent predicted | |
| Change From Baseline to Week 12 in the Percent Predicted Slow Vital Capacity (SVC) | Reldesemtiv 150 mg Twice Daily | -4.97 | Standard Error 0.952 | percent predicted | |
| Change From Baseline to Week 12 in the Percent Predicted Slow Vital Capacity (SVC) | Reldesemtiv 300 mg Twice Daily | -4.62 | Standard Error 0.963 | percent predicted | |
| Change From Baseline to Week 12 in the Percent Predicted Slow Vital Capacity (SVC) | Reldesemtiv 450 mg Twice Daily | -4.58 | Standard Error 0.927 | percent predicted | |
| Change From Baseline to Week 12 in the Percent Predicted Slow Vital Capacity (SVC) | Reldesemtiv 300 mg & 450 mg | -4.60 | Standard Error 0.701 | percent predicted | |
| Change From Baseline to Week 12 in the ALS Functional Rating Scale - Revised (ALSFRS-R) Total Score | Placebo | -3.53 | Standard Error 0.313 | change in score | |
| Change From Baseline to Week 12 in the ALS Functional Rating Scale - Revised (ALSFRS-R) Total Score | Reldesemtiv 150 mg Twice Daily | -2.40 | Standard Error 0.311 | change in score | |
| Change From Baseline to Week 12 in the ALS Functional Rating Scale - Revised (ALSFRS-R) Total Score | Reldesemtiv 300 mg Twice Daily | -2.62 | Standard Error 0.317 | change in score | |
| Change From Baseline to Week 12 in the ALS Functional Rating Scale - Revised (ALSFRS-R) Total Score | Reldesemtiv 450 mg Twice Daily | -2.94 | Standard Error 0.307 | change in score | |
| Change From Baseline to Week 12 in the ALS Functional Rating Scale - Revised (ALSFRS-R) Total Score | Reldesemtiv 300 mg & 450 mg | -2.78 | Standard Error 0.228 | change in score |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 115 | |
| Overall Study | STARTED | Reldesemtiv 150 mg Twice Daily | 113 | |
| Overall Study | STARTED | Reldesemtiv 300 mg Twice Daily | 113 | |
| Overall Study | STARTED | Reldesemtiv 450 mg Twice Daily | 117 | |
| Overall Study | COMPLETED | Placebo | 95 | |
| Overall Study | COMPLETED | Reldesemtiv 150 mg Twice Daily | 100 | |
| Overall Study | COMPLETED | Reldesemtiv 300 mg Twice Daily | 97 | |
| Overall Study | COMPLETED | Reldesemtiv 450 mg Twice Daily | 98 | |
| Overall Study | NOT COMPLETED | Placebo | 20 | |
| Overall Study | NOT COMPLETED | Reldesemtiv 150 mg Twice Daily | 13 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events232
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 | Nausea | Gastrointestinal disorders | Placebo | 14 | 115 | 16 |
| other | Nausea | Gastrointestinal disorders | Reldesemtiv 150 mg Twice Daily | 10 | 112 | 13 |
| other | Nausea | Gastrointestinal disorders | Reldesemtiv 300 mg Twice Daily | 13 | 113 | 14 |
| other | Nausea | Gastrointestinal disorders | Reldesemtiv 450 mg Twice Daily | 22 | 117 | 23 |
| other | Constipation | Gastrointestinal disorders | Placebo | 5 | 115 | 5 |
| other | Constipation | Gastrointestinal disorders | Reldesemtiv 150 mg Twice Daily | 7 | 112 | 8 |
| other | Constipation | Gastrointestinal disorders | Reldesemtiv 300 mg Twice Daily | 13 | 113 | 15 |
| other | Constipation | Gastrointestinal disorders | Reldesemtiv 450 mg Twice Daily | 10 | 117 | 10 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 8 | 115 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | Reldesemtiv 150 mg Twice Daily | 12 | 112 | 15 |
1 to 10 of 232Source ClinicalTrials.gov
See all 232 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 2 | 115 |
| Total, all-cause mortality | Reldesemtiv 150 mg Twice Daily | 0 | 112 |
| Total, all-cause mortality | Reldesemtiv 300 mg Twice Daily | 0 | 113 |
| Total, all-cause mortality | Reldesemtiv 450 mg Twice Daily | 1 | 117 |
| Total, other adverse events | Placebo | 95 | 115 |
| Total, other adverse events | Reldesemtiv 150 mg Twice Daily | 99 | 112 |
| Total, other adverse events | Reldesemtiv 300 mg Twice Daily | 97 | 113 |
| Total, other adverse events | Reldesemtiv 450 mg Twice Daily | 107 | 117 |
| Total, serious adverse events | Placebo | 10 | 115 |
| Total, serious adverse events | Reldesemtiv 150 mg Twice Daily | 8 | 112 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers6
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/NCT03160898
GET https://conductscience.org/api/trials/v1/NCT03160898/events?page=2