Trial · NCT02644668

A Study of CK-2127107 in Patients With Spinal Muscular Atrophy

NCT02644668, Phase 2, Completed, Cytokinetics; results first posted 2020-08-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of CK-2127107 in Patients With Spinal Muscular Atrophy. Trials, record NCT02644668. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02644668

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Trial

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

Title: A Study of CK-2127107 in Patients With Spinal Muscular Atrophy
NCT number: NCT02644668
Status: Completed
Phases: Phase 2
Enrollment: 70 participants, actual
Lead sponsor: Cytokinetics
Conditions: Spinal Muscular Atrophy
Interventions: Placebo, Reldesemtiv 150 mg, Reldesemtiv 450 mg
First posted: 2016-01-01
Last updated: 2020-08-31
Results first posted: 2020-08-31

Source ClinicalTrials.gov

Registered outcomes12

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

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 8 in Forced Vital Capacity (FVC)	baseline and 8 weeks	FVC was measured using a calibrated spirometer (in units of liters). Patients were instructed to take as deep an inspiration as possible followed by a maximum exhalation (blowing out all the air in their lungs).
Primary	Change From Baseline to Week 8 in Maximum Inspiratory Pressure (MIP)	baseline and 8 weeks	MIP was measured (in units of cm H20) using a calibrated spirometer with an inspiratory pressure valve attached. For the test, patients were asked to inhale as forcefully as possible, to their maximum pressure.
Primary	Change From Baseline to Week 8 in Maximum Expiratory Pressure (MEP)	baseline and 8 weeks	MEP was measured (in units of cm H20) using a calibrated spirometer with an exspiratory pressure valve attached. For the test, patients were asked to maximally inhale then perform a forced exhalation with as forcefully as possible.
Primary	Muscle Strength Mega-Score at Week 8	baseline and 8 weeks	Muscle strength of 3 muscle groups (elbow flexion, knee extension, and shoulder abduction) were measured bilaterally using a hand-held dynamometer. Muscle strength was measured twice for each body location; if the variability between the 2 measures was \> 15%, a third measure was obtained. The maximum muscle strength of the 2 measurements was identified and transformed as a percent change from baseline using the equation: (\[postbaseline value - baseline value\] / baseline value) × 100. The mega-score was a composite score that averaged strength across the 3 muscle groups. It was calculated as the mean of the non-missing transformed muscle strength scores among the 3 muscle groups each measure bilaterally (totaling 6 body locations).
Primary	Change From Baseline to Week 8 in the Hammersmith Functional Motor Scale-Expanded (HFMS-E)	baseline and 8 weeks	The HFMS-E evaluated the level of independent mobility and motor skills through assessment of 33 test-items, each scored from 0 (worse) to 2 (better). The total score was calculated as the sum of the scores among the 33 test items, and has a range from 0 to 66.
Primary	Change From Baseline to Week 8 in Revised Upper Limb Module (RULM)	baseline and 8 weeks	The RULM assessed motor function in the upper limbs (specifically shoulder, elbow, wrist, and hand function) that related to activities of everyday life. The RULM consisted of 20 items, 1 of which was scored on a 7-point scale (from 0 to 6), 18 were scored on a 3-point scale (from 0 to 2), and 1 was scored on a 2-point scale (0 or 1). The total score was the sum of each response and could range from a minimum of 0 to a maximum of 43 points. Higher scores reflected better motor function.
Primary	Change From Baseline to Week 8 in the TUG Test	baseline and 8 weeks	The TUG test measured the time (in seconds) it took for a patient to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down.
Primary	Change From Baseline to Week 8 in the 6MWT	baseline and 8 weeks	The 6MWT measured the distance (in meters) a patient walked in 6 minutes.
Primary	Patient Global Assessment at the End of Week 8	8 weeks	Patients assessed whether they felt the same, better, or worse than prior to dosing on Day 1.
Primary	Investigator Global Assessment at the End of Week 8	8 weeks	The Investigator assessed whether patient appeared the same, better, or worse than prior to dosing on Day 1.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

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 8 in Forced Vital Capacity (FVC)	baseline and 8 weeks	The analysis population includes patients who received at least 1 dose of reldesemtiv and had results from the relevant outcome measure at Week 8.	liters	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline to Week 8 in Maximum Inspiratory Pressure (MIP)	baseline and 8 weeks	The analysis population includes patients who received at least 1 dose of reldesemtiv and had results from the relevant outcome measure at Week 8.	cm H2O	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline to Week 8 in Maximum Expiratory Pressure (MEP)	baseline and 8 weeks	The analysis population includes patients who received at least 1 dose of reldesemtiv and had results from the relevant outcome measure at Week 8.	cm H2O	LEAST_SQUARES_MEAN
PRIMARY	Muscle Strength Mega-Score at Week 8	baseline and 8 weeks	The analysis population includes patients who received at least 1 dose of reldesemtiv and had results from the relevant outcome measure at Week 8.	percent change	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline to Week 8 in the Hammersmith Functional Motor Scale-Expanded (HFMS-E)	baseline and 8 weeks	The analysis population includes patients who received at least 1 dose of reldesemtiv and had results from the relevant outcome measure at Week 8.	score on a scale	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline to Week 8 in Revised Upper Limb Module (RULM)	baseline and 8 weeks	The analysis population includes patients who received at least 1 dose of reldesemtiv and had results from the relevant outcome measure at Week 8.	score on a scale	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline to Week 8 in the TUG Test	baseline and 8 weeks	This test was evaluated in ambulatory patients only.	seconds	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline to Week 8 in the 6MWT	baseline and 8 weeks	This test was evaluated in ambulatory patients only.	meters	LEAST_SQUARES_MEAN
PRIMARY	Patient Global Assessment at the End of Week 8	8 weeks	The analysis population includes patients who received at least 1 dose of reldesemtiv and had results from the relevant outcome measure at Week 8.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Investigator Global Assessment at the End of Week 8	8 weeks	The analysis population includes patients who received at least 1 dose of reldesemtiv and had results from the relevant outcome measure at Week 8.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group46

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

Outcome	Group	Value	Spread	Units
Change From Baseline to Week 8 in Forced Vital Capacity (FVC)	Placebo	-0.02	Standard Error 0.042	liters
Change From Baseline to Week 8 in Forced Vital Capacity (FVC)	Reldesemtiv 150 mg Twice Daily	-0.03	Standard Error 0.043	liters
Change From Baseline to Week 8 in Forced Vital Capacity (FVC)	Reldesemtiv 450 mg Twice Daily	-0.07	Standard Error 0.050	liters
Change From Baseline to Week 8 in Maximum Inspiratory Pressure (MIP)	Placebo	-2.62	Standard Error 3.317	cm H2O
Change From Baseline to Week 8 in Maximum Inspiratory Pressure (MIP)	Reldesemtiv 150 mg Twice Daily	-5.56	Standard Error 3.401	cm H2O
Change From Baseline to Week 8 in Maximum Inspiratory Pressure (MIP)	Reldesemtiv 450 mg Twice Daily	-1.63	Standard Error 3.901	cm H2O
Change From Baseline to Week 8 in Maximum Expiratory Pressure (MEP)	Placebo	-4.22	Standard Error 3.843	cm H2O
Change From Baseline to Week 8 in Maximum Expiratory Pressure (MEP)	Reldesemtiv 150 mg Twice Daily	7.47	Standard Error 3.941	cm H2O
Change From Baseline to Week 8 in Maximum Expiratory Pressure (MEP)	Reldesemtiv 450 mg Twice Daily	8.93	Standard Error 4.517	cm H2O
Muscle Strength Mega-Score at Week 8	Placebo	14.34	Standard Error 5.298	percent change

1 to 10 of 46Source ClinicalTrials.gov

See all 46 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	26
Overall Study	STARTED	Reldesemtiv 150 mg Twice Daily	24
Overall Study	STARTED	Reldesemtiv 450 mg Twice Daily	20
Overall Study	COMPLETED	Placebo	24
Overall Study	COMPLETED	Reldesemtiv 150 mg Twice Daily	24
Overall Study	COMPLETED	Reldesemtiv 450 mg Twice Daily	17
Overall Study	NOT COMPLETED	Placebo	2
Overall Study	NOT COMPLETED	Reldesemtiv 150 mg Twice Daily	0
Overall Study	NOT COMPLETED	Reldesemtiv 450 mg Twice Daily	3

Source ClinicalTrials.gov

Adverse events141

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	Headache	Nervous system disorders	Placebo	5	26	5
other	Headache	Nervous system disorders	Reldesemtiv 150 mg Twice Daily	6	24	6
other	Headache	Nervous system disorders	Reldesemtiv 450 mg Twice Daily	5	20	7
other	Constipation	Gastrointestinal disorders	Placebo	0	26	0
other	Constipation	Gastrointestinal disorders	Reldesemtiv 150 mg Twice Daily	3	24	3
other	Constipation	Gastrointestinal disorders	Reldesemtiv 450 mg Twice Daily	2	20	2
other	Nausea	Gastrointestinal disorders	Placebo	5	26	5
other	Nausea	Gastrointestinal disorders	Reldesemtiv 150 mg Twice Daily	3	24	4
other	Nausea	Gastrointestinal disorders	Reldesemtiv 450 mg Twice Daily	2	20	2
other	Diarrhoea	Gastrointestinal disorders	Placebo	2	26	2

1 to 10 of 141Source ClinicalTrials.gov

See all 141 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	26
Total, all-cause mortality	Reldesemtiv 150 mg Twice Daily	0	24
Total, all-cause mortality	Reldesemtiv 450 mg Twice Daily	0	20
Total, other adverse events	Placebo	24	26
Total, other adverse events	Reldesemtiv 150 mg Twice Daily	20	24
Total, other adverse events	Reldesemtiv 450 mg Twice Daily	17	20
Total, serious adverse events	Placebo	0	26
Total, serious adverse events	Reldesemtiv 150 mg Twice Daily	2	24
Total, serious adverse events	Reldesemtiv 450 mg Twice Daily	2	20

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.

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.

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