Trial · NCT01709149
Study of Safety, Tolerability & Efficacy of CK-2017357 in Amyotrophic Lateral Sclerosis (ALS)
NCT01709149, Phase 2, Completed, Cytokinetics; results first posted 2020-03-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Safety, Tolerability & Efficacy of CK-2017357 in Amyotrophic Lateral Sclerosis (ALS). Trials, record NCT01709149. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01709149
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Safety, Tolerability & Efficacy of CK-2017357 in Amyotrophic Lateral Sclerosis (ALS)
- NCT number
- NCT01709149
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 711 participants, actual
- Lead sponsor
- Cytokinetics
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- CK-2017357, Placebo tablets, Riluzole
- First posted
- 2012-10-18
- Last updated
- 2020-03-31
- Results first posted
- 2020-03-31
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Change From Baseline in ALS Functional Rating Scale-Revised (ALSFRS-R) Total Score to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment | Baseline, 8 weeks, 12 weeks | The ALSFRS-R is used to measure the progression and severity of disease; it consists of 12 questions, assessing a patient's capability and independence in functional activities relevant to ALS, categorized in 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, with higher scores reflecting more normal function and lower scores reflecting more impaired function. |
| Secondary | Change From Baseline in Maximum Voluntary Ventilation (MVV) to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment | Baseline, 8 weeks, 12 weeks | MVV was measured as the volume (in liters) of air that could be exhaled during 12 seconds of rapid deep breathing; for analysis purposes, the measured volume was extrapolated to 1 minute (to give units of L/min). |
| Secondary | Change From Baseline in Sniff Nasal Inspiratory Pressure (SNIP) to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment | Baseline, 8 weeks, 12 weeks | SNIP was measured at functional residual capacity, the bottom of the tidal breathing cycle, through 1 plugged nostril while the other remained open. Inspiratory pressure is a negative number where a larger negative number represents . . . A forceful, maximal inspiratory sniff was performed and a peak pressure value reported. The best result (ie, the highest number) from 5 tests was recorded as the SNIP. |
| Secondary | Change From Baseline in Slow Vital Capacity (SVC) to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment | Baseline, 8 weeks, 12 weeks | SVC was measured using a spirometer (in units of liters). Following 3 to 5 breaths at rest, the 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 % predicted values (ie, the test result as a percent of predicted values for the patients of similar demographic and baseline characteristics \[eg, height, age, sex\]). |
| Secondary | Change From Baseline in Maximum Handgrip Strength in the Weaker Hand to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment | Baseline, 8 weeks, 12 weeks | Maximum handgrip strength was measured using an electronic hand dynamometer; patients were asked to squeeze the device with the maximum possible force. |
| Secondary | Change From Baseline in Handgrip Fatigability (at 60% of Target in the Weaker Hand) to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment | Baseline, 8 weeks, 12 weeks | Handgrip fatigability was measured immediately following determination of maximum handgrip strength (via an electronic hand dynamometer). Once maximum handgrip strength was achieved, the force of the grip was timed for 2 minutes or until the grip strength had dropped to 60% of the maximum, whichever came first. |
| Secondary | Change From Baseline in Muscle Strength Mega-Score Based on Percent Change in Muscle Strength Measurements to the Average at the End of Weeks 8 and 12 of Double-blind Treatment | Baseline, 8 weeks, 12 weeks | A hand-held dynamometer (HHD), 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 (bilateral), wrist extension (bilateral), knee extension (bilateral), and ankle dorsiflexion (bilateral). For each assessment time point, the percent change from baseline was calculated for each muscle group and handgrip strength. The muscle strength mega-score was calculated as the average of the changes (ie, percent change from baseline) observed for each muscle groups as well as handgrip strength. For this endpoint, negative values indicate a decline in muscle strength. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Change From Baseline in ALS Functional Rating Scale-Revised (ALSFRS-R) Total Score to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment | Baseline, 8 weeks, 12 weeks | Modified Full Analysis Set | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Maximum Voluntary Ventilation (MVV) to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment | Baseline, 8 weeks, 12 weeks | Modified Full Analysis Set | L/min | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Sniff Nasal Inspiratory Pressure (SNIP) to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment | Baseline, 8 weeks, 12 weeks | Modified Full Analysis Set | cm H2O | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Slow Vital Capacity (SVC) to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment | Baseline, 8 weeks, 12 weeks | Modified Full Analysis Set | % predicted | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Maximum Handgrip Strength in the Weaker Hand to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment | Baseline, 8 weeks, 12 weeks | pounds | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline in Handgrip Fatigability (at 60% of Target in the Weaker Hand) to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment | Baseline, 8 weeks, 12 weeks | Modified Full Analysis Set | seconds | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Muscle Strength Mega-Score Based on Percent Change in Muscle Strength Measurements to the Average at the End of Weeks 8 and 12 of Double-blind Treatment | Baseline, 8 weeks, 12 weeks | percent change | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Change From Baseline in ALS Functional Rating Scale-Revised (ALSFRS-R) Total Score to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment | Placebo | -2.40 | Standard Error 0.246 | units on a scale | |
| The Change From Baseline in ALS Functional Rating Scale-Revised (ALSFRS-R) Total Score to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment | Tirasemtiv | -2.98 | Standard Error 0.277 | units on a scale | |
| Change From Baseline in Maximum Voluntary Ventilation (MVV) to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment | Placebo | -4.27 | Standard Error 1.332 | L/min | |
| Change From Baseline in Maximum Voluntary Ventilation (MVV) to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment | Tirasemtiv | -3.79 | Standard Error 1.497 | L/min | |
| Change From Baseline in Sniff Nasal Inspiratory Pressure (SNIP) to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment | Placebo | -0.89 | Standard Error 1.103 | cm H2O | |
| Change From Baseline in Sniff Nasal Inspiratory Pressure (SNIP) to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment | Tirasemtiv | -4.29 | Standard Error 1.243 | cm H2O | |
| Change From Baseline in Slow Vital Capacity (SVC) to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment | Placebo | -7.24 | Standard Error 0.691 | % predicted | |
| Change From Baseline in Slow Vital Capacity (SVC) to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment | Tirasemtiv | -2.98 | Standard Error 0.780 | % predicted | |
| Change From Baseline in Maximum Handgrip Strength in the Weaker Hand to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment | Placebo | -3.54 | Standard Error 0.640 | pounds | |
| Change From Baseline in Maximum Handgrip Strength in the Weaker Hand to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment | Tirasemtiv | -2.78 | Standard Error 0.714 | pounds |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-label Lead-in Phase | STARTED | Open-label lead-in Treatment: Tirasemtiv | 711 | |
| Open-label Lead-in Phase | STARTED | Double-blind Treatment: Placebo | 0 | |
| Open-label Lead-in Phase | STARTED | Double-blind Treatment: Tirasemtiv | 0 | |
| Open-label Lead-in Phase | COMPLETED | Open-label lead-in Treatment: Tirasemtiv | 596 | |
| Open-label Lead-in Phase | COMPLETED | Double-blind Treatment: Placebo | 0 | |
| Open-label Lead-in Phase | COMPLETED | Double-blind Treatment: Tirasemtiv | 0 | |
| Open-label Lead-in Phase | NOT COMPLETED | Open-label lead-in Treatment: Tirasemtiv | 115 | |
| Open-label Lead-in Phase | NOT COMPLETED | Double-blind Treatment: Placebo | 0 | |
| Open-label Lead-in Phase | NOT COMPLETED | Double-blind Treatment: Tirasemtiv | 0 | |
| Double-blind, Placebo-controlled Phase | STARTED | Open-label lead-in Treatment: Tirasemtiv | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events219
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 | Dizziness | Nervous system disorders | Open-label lead-in Treatment: Tirasemtiv | 291 | 711 | |
| other | Dizziness | Nervous system disorders | Double-blind Treatment: Placebo | 58 | 295 | |
| other | Dizziness | Nervous system disorders | Double-blind Treatment: Tirasemtiv | 153 | 301 | |
| other | Fatigue | General disorders | Open-label lead-in Treatment: Tirasemtiv | 111 | 711 | |
| other | Fatigue | General disorders | Double-blind Treatment: Placebo | 42 | 295 | |
| other | Fatigue | General disorders | Double-blind Treatment: Tirasemtiv | 100 | 301 | |
| other | Nausea | Gastrointestinal disorders | Open-label lead-in Treatment: Tirasemtiv | 77 | 711 | |
| other | Nausea | Gastrointestinal disorders | Double-blind Treatment: Placebo | 23 | 295 | |
| other | Nausea | Gastrointestinal disorders | Double-blind Treatment: Tirasemtiv | 66 | 301 | |
| other | Headache | Nervous system disorders | Open-label lead-in Treatment: Tirasemtiv | 30 | 711 |
1 to 10 of 219Source ClinicalTrials.gov
See all 219 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open-label lead-in Treatment: Tirasemtiv | 2 | 711 |
| Total, all-cause mortality | Double-blind Treatment: Placebo | 3 | 295 |
| Total, all-cause mortality | Double-blind Treatment: Tirasemtiv | 2 | 301 |
| Total, other adverse events | Open-label lead-in Treatment: Tirasemtiv | 525 | 711 |
| Total, other adverse events | Double-blind Treatment: Placebo | 258 | 295 |
| Total, other adverse events | Double-blind Treatment: Tirasemtiv | 291 | 301 |
| Total, serious adverse events | Open-label lead-in Treatment: Tirasemtiv | 13 | 711 |
| Total, serious adverse events | Double-blind Treatment: Placebo | 16 | 295 |
| Total, serious adverse events | Double-blind Treatment: Tirasemtiv | 27 | 301 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01709149
GET https://conductscience.org/api/trials/v1/NCT01709149/events?page=2