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Trial record 3 of 6 for:    CK-2127107

A Study to Evaluate Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS) (FORTITUDE-ALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03160898
Recruitment Status : Completed
First Posted : May 19, 2017
Results First Posted : September 11, 2020
Last Update Posted : September 11, 2020
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Cytokinetics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Amyotrophic Lateral Sclerosis
Interventions Drug: Reldesemtiv
Drug: Placebo
Enrollment 458
Recruitment Details Patients with familial or sporadic ALS were enrolled at 65 sites in Australia, Canada, Ireland, Netherlands, Spain, and the United States. The first patient was screened on 16 August 2017 and the last patient completed on 07 March 2019.
Pre-assignment Details Eligible patients were male or female, ≥18 - ≤80 years of age, with familial or sporadic ALS diagnosed for ≤24 months. At screening, patients were to have upright slow vial capacity (SVC) ≥60% of predicted; must have been able to swallow tablets, perform reproducible pulmonary function tests; have normal lab tests; and have a caregiver (if needed).
Arm/Group Title Placebo Reldesemtiv 150 mg Twice Daily Reldesemtiv 300 mg Twice Daily Reldesemtiv 450 mg Twice Daily
Hide Arm/Group Description Patients in this group received placebo twice daily for 12 weeks Patients in this group received 150 mg reldesemtiv twice daily for 12 weeks Patients in this group received 300 mg reldesemtiv twice daily for 12 weeks Patients in this group received 450 mg reldesemtiv twice daily for 12 weeks
Period Title: Overall Study
Started 115 113 [1] 113 117
Completed 95 100 97 98
Not Completed 20 13 16 19
Reason Not Completed
Adverse Event             4             8             7             10
Death             1             0             0             1
Difficulty Traveling to Clinic Visits             3             0             0             1
Lost to Follow-up             1             1             1             2
Physician Decision             1             0             0             1
Progressive Disease             4             1             2             1
Protocol Violation             1             0             2             0
Sponsor Discretion             2             0             0             0
Withdrawal by Subject             1             3             2             1
Other             2             0             2             2
[1]
1 patient withdrew consent before study drug dosing and was therefore excluded from safety analysis
Arm/Group Title Placebo Reldesemtiv 150 mg Twice Daily Reldesemtiv 300 mg Twice Daily Reldesemtiv 450 mg Twice Daily Total
Hide Arm/Group Description Patients in this group received placebo twice daily for 12 weeks Patients in this group received 150 mg reldesemtiv twice daily for 12 weeks Patients in this group received 300 mg reldesemtiv twice daily for 12 weeks Patients in this group received 450 mg reldesemtiv twice daily for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 115 112 113 117 457
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 115 participants 112 participants 113 participants 117 participants 457 participants
59.6  (10.60) 57.1  (10.91) 57.8  (10.17) 60.1  (11.00) 58.7  (10.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants 112 participants 113 participants 117 participants 457 participants
Female
47
  40.9%
41
  36.6%
42
  37.2%
50
  42.7%
180
  39.4%
Male
68
  59.1%
71
  63.4%
71
  62.8%
67
  57.3%
277
  60.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants 112 participants 113 participants 117 participants 457 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   3.5%
2
   1.8%
7
   6.2%
1
   0.9%
14
   3.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.9%
0
   0.0%
0
   0.0%
1
   0.2%
Black or African American
1
   0.9%
3
   2.7%
6
   5.3%
0
   0.0%
10
   2.2%
White
107
  93.0%
103
  92.0%
100
  88.5%
113
  96.6%
423
  92.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   2.6%
3
   2.7%
0
   0.0%
3
   2.6%
9
   2.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 115 participants 112 participants 113 participants 117 participants 457 participants
Canada 24 22 27 27 100
Netherlands 4 2 1 4 11
United States 72 73 71 68 284
Ireland 2 2 0 0 4
Spain 8 9 10 11 38
Australia 5 4 4 7 20
Time since ALS symptom onset  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 115 participants 112 participants 113 participants 117 participants 457 participants
22.13  (12.375) 23.87  (27.503) 22.52  (14.635) 22.69  (18.662) 22.80  (19.080)
Site of symptom onset  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants 112 participants 113 participants 117 participants 457 participants
Upper limb
49
  42.6%
52
  46.4%
56
  49.6%
44
  37.6%
201
  44.0%
Lower limb
44
  38.3%
42
  37.5%
40
  35.4%
43
  36.8%
169
  37.0%
Bulbar
22
  19.1%
18
  16.1%
17
  15.0%
30
  25.6%
87
  19.0%
1.Primary Outcome
Title Change From Baseline to Week 12 in the Percent Predicted Slow Vital Capacity (SVC)
Hide Description 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]).
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Reldesemtiv 150 mg Twice Daily Reldesemtiv 300 mg Twice Daily Reldesemtiv 450 mg Twice Daily Reldesemtiv 300 mg & 450 mg
Hide Arm/Group Description:
Patients in this group received placebo twice daily for 12 weeks
Patients in this group received 150 mg reldesemtiv twice daily for 12 weeks
Patients in this group received 300 mg reldesemtiv twice daily for 12 weeks
Patients in this group received 450 mg reldesemtiv twice daily for 12 weeks
For analysis purposes, the results from the reldesemtiv 300 mg group and the 450 mg group were pooled.
Overall Number of Participants Analyzed 114 112 113 117 230
Least Squares Mean (Standard Error)
Unit of Measure: percent predicted
-6.46  (0.964) -4.97  (0.952) -4.62  (0.963) -4.58  (0.927) -4.60  (0.701)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Reldesemtiv 150 mg Twice Daily, Reldesemtiv 300 mg Twice Daily, Reldesemtiv 450 mg Twice Daily
Comments

The statistical null hypothesis was as follows: there was no assumed dose-response relationship in percent predicted SVC change from baseline to Week 12 among all three active doses and placebo, expressed as:

H0: -5 x µ placebo - 1 x µ 150 mg twice daily + 3 x µ 300 mg twice daily + 3 x µ 450 mg twice daily = 0 where µ was the mean of the efficacy endpoint for the designated group.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1095
Comments [Not Specified]
Method Mixed Models Analysis
Comments Analyzed by an MMRM with contrast (-5, -1, 3, 3) to reflect the assumed relationship for the 4 groups: placebo, 150, 300, and 450 mg twice daily.
Method of Estimation Estimation Parameter least squares mean treatment difference
Estimated Value 1.61
Confidence Interval (2-Sided) 95%
-0.36 to 3.58
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.003
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Reldesemtiv 150 mg Twice Daily
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2501
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 1.49
Confidence Interval (2-Sided) 95%
-1.05 to 4.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.291
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Reldesemtiv 300 mg Twice Daily
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1549
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 1.84
Confidence Interval (2-Sided) 95%
-0.7 to 4.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Reldesemtiv 450 mg Twice Daily
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1417
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 1.88
Confidence Interval (2-Sided) 95%
-0.63 to 4.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.274
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Reldesemtiv 300 mg & 450 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0964
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 1.86
Confidence Interval (2-Sided) 95%
-0.33 to 4.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.115
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to Week 12 in the ALS Functional Rating Scale - Revised (ALSFRS-R) Total Score
Hide Description 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.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Reldesemtiv 150 mg Twice Daily Reldesemtiv 300 mg Twice Daily Reldesemtiv 450 mg Twice Daily Reldesemtiv 300 mg & 450 mg
Hide Arm/Group Description:
Patients in this group received placebo twice daily for 12 weeks
Patients in this group received 150 mg reldesemtiv twice daily for 12 weeks
Patients in this group received 300 mg reldesemtiv twice daily for 12 weeks
Patients in this group received 450 mg reldesemtiv twice daily for 12 weeks
For analysis purposes, the results from the reldesemtiv 300 mg group and the 450 mg group were pooled.
Overall Number of Participants Analyzed 114 112 113 117 230
Least Squares Mean (Standard Error)
Unit of Measure: change in score
-3.53  (0.313) -2.40  (0.311) -2.62  (0.317) -2.94  (0.307) -2.78  (0.228)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Reldesemtiv 150 mg Twice Daily, Reldesemtiv 300 mg Twice Daily, Reldesemtiv 450 mg Twice Daily
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0930
Comments [Not Specified]
Method Mixed Models Analysis
Comments Analyzed by an MMRM with contrast (-5, -1, 3, 3) to reflect the assumed relationship for the 4 groups: placebo, 150, 300, and 450 mg twice daily.
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.56
Confidence Interval (2-Sided) 95%
-0.09 to 1.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.335
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Reldesemtiv 150 mg Twice Daily
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0087
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.29 to 1.97
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.427
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Reldesemtiv 300 mg Twice Daily
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0351
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.06 to 1.75
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Reldesemtiv 450 mg Twice Daily
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1642
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
-0.24 to 1.43
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.425
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Reldesemtiv 300 mg & 450 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0435
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.02 to 1.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.371
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Slope of Muscle Strength Mega-score From Baseline to Week 12
Hide Description 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.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Reldesemtiv 150 mg Twice Daily Reldesemtiv 300 mg Twice Daily Reldesemtiv 450 mg Twice Daily Reldesemtiv 300 mg & 450 mg
Hide Arm/Group Description:
Patients in this group received placebo twice daily for 12 weeks
Patients in this group received 150 mg reldesemtiv twice daily for 12 weeks
Patients in this group received 300 mg reldesemtiv twice daily for 12 weeks
Patients in this group received 450 mg reldesemtiv twice daily for 12 weeks
For analysis purposes, the results from the reldesemtiv 300 mg group and the 450 mg group were pooled.
Overall Number of Participants Analyzed 114 112 113 117 230
Least Squares Mean (Standard Error)
Unit of Measure: change in mega-score per day
-0.1444  (0.02492) -0.1198  (0.02463) -0.1299  (0.02474) -0.0956  (0.02421) -0.1127  (0.01731)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Reldesemtiv 150 mg Twice Daily, Reldesemtiv 300 mg Twice Daily, Reldesemtiv 450 mg Twice Daily
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3134
Comments [Not Specified]
Method Mixed Models Analysis
Comments Analyzed by an MMRM with contrast (-5, -1, 3, 3) to reflect the assumed relationship for the 4 groups: placebo, 150, 300, and 450 mg twice daily.
Method of Estimation Estimation Parameter Slope difference
Estimated Value 0.0276
Confidence Interval (2-Sided) 95%
-0.0261 to 0.0813
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02734
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Reldesemtiv 150 mg Twice Daily
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4824
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.0246
Confidence Interval (2-Sided) 95%
-0.0442 to 0.0935
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Reldesemtiv 300 mg Twice Daily
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6787
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.0146
Confidence Interval (2-Sided) 95%
-0.0544 to 0.0835
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Reldesemtiv 450 mg Twice Daily
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1604
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.0488
Confidence Interval (2-Sided) 95%
-0.0194 to 0.1171
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Reldesemtiv 300 mg & 450 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2966
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.0317
Confidence Interval (2-Sided) 95%
-0.0279 to 0.0913
Estimation Comments [Not Specified]
Time Frame Adverse events (AEs) were collected from administration of the first dose of study drug through 4 weeks after the last dose of study drug.
Adverse Event Reporting Description

An AE was treatment-emergent if it started or worsened (eg, increased in severity) during or after the first dose of study drug.

AEs and SAEs were summarized for the Safety Analysis Set, which consisted of all randomized patients who received at least 1 dose or portion of a dose of study drug.

 
Arm/Group Title Placebo Reldesemtiv 150 mg Twice Daily Reldesemtiv 300 mg Twice Daily Reldesemtiv 450 mg Twice Daily
Hide Arm/Group Description Patients in this group received placebo twice daily for 12 weeks Patients in this group received 150 mg reldesemtiv twice daily for 12 weeks Patients in this group received 300 mg reldesemtiv twice daily for 12 weeks Patients in this group received 450 mg reldesemtiv twice daily for 12 weeks
All-Cause Mortality
Placebo Reldesemtiv 150 mg Twice Daily Reldesemtiv 300 mg Twice Daily Reldesemtiv 450 mg Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/115 (1.74%)      0/112 (0.00%)      0/113 (0.00%)      1/117 (0.85%)    
Hide Serious Adverse Events
Placebo Reldesemtiv 150 mg Twice Daily Reldesemtiv 300 mg Twice Daily Reldesemtiv 450 mg Twice Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/115 (8.70%)      8/112 (7.14%)      8/113 (7.08%)      8/117 (6.84%)    
Cardiac disorders         
Cardiac failure  1  0/115 (0.00%)  0 0/112 (0.00%)  0 1/113 (0.88%)  1 0/117 (0.00%)  0
Palpitations  1  0/115 (0.00%)  0 0/112 (0.00%)  0 1/113 (0.88%)  1 0/117 (0.00%)  0
Acute myocardial infarction  1  1/115 (0.87%)  1 0/112 (0.00%)  0 0/113 (0.00%)  0 0/117 (0.00%)  0
Gastrointestinal disorders         
Dysphagia  1  0/115 (0.00%)  0 2/112 (1.79%)  2 0/113 (0.00%)  0 0/117 (0.00%)  0
Oesophagitis  1  0/115 (0.00%)  0 1/112 (0.89%)  1 0/113 (0.00%)  0 0/117 (0.00%)  0
Rectal prolapse  1  1/115 (0.87%)  1 0/112 (0.00%)  0 0/113 (0.00%)  0 0/117 (0.00%)  0
General disorders         
Pain  1  0/115 (0.00%)  0 1/112 (0.89%)  1 0/113 (0.00%)  0 0/117 (0.00%)  0
Hepatobiliary disorders         
Hepatotoxicity  1  0/115 (0.00%)  0 0/112 (0.00%)  0 1/113 (0.88%)  1 1/117 (0.85%)  1
Infections and infestations         
Urinary tract infection  1  1/115 (0.87%)  1 1/112 (0.89%)  1 1/113 (0.88%)  1 0/117 (0.00%)  0
Appendicitis  1  0/115 (0.00%)  0 1/112 (0.89%)  1 0/113 (0.00%)  0 0/117 (0.00%)  0
Device related sepsis  1  0/115 (0.00%)  0 0/112 (0.00%)  0 1/113 (0.88%)  1 0/117 (0.00%)  0
Parainfluenzae virus infection  1  0/115 (0.00%)  0 0/112 (0.00%)  0 1/113 (0.88%)  1 0/117 (0.00%)  0
Pneumonia  1  1/115 (0.87%)  1 0/112 (0.00%)  0 0/113 (0.00%)  0 0/117 (0.00%)  0
Urosepsis  1  1/115 (0.87%)  1 0/112 (0.00%)  0 0/113 (0.00%)  0 0/117 (0.00%)  0
Injury, poisoning and procedural complications         
Head injury  1  0/115 (0.00%)  0 0/112 (0.00%)  0 0/113 (0.00%)  0 1/117 (0.85%)  1
Joint dislocation  1  0/115 (0.00%)  0 1/112 (0.89%)  1 0/113 (0.00%)  0 0/117 (0.00%)  0
Traumatic fracture  1  0/115 (0.00%)  0 0/112 (0.00%)  0 1/113 (0.88%)  1 0/117 (0.00%)  0
Investigations         
Alanine aminotransferase increased  1  0/115 (0.00%)  0 0/112 (0.00%)  0 0/113 (0.00%)  0 2/117 (1.71%)  2
Aspartate aminotransferase increased  1  0/115 (0.00%)  0 0/112 (0.00%)  0 0/113 (0.00%)  0 1/117 (0.85%)  1
Blood creatine phosphokinase increased  1  0/115 (0.00%)  0 0/112 (0.00%)  0 0/113 (0.00%)  0 1/117 (0.85%)  1
Glomerular filtration rate decreased  1  0/115 (0.00%)  0 0/112 (0.00%)  0 0/113 (0.00%)  0 1/117 (0.85%)  1
Weight decreased  1  1/115 (0.87%)  1 1/112 (0.89%)  1 0/113 (0.00%)  0 0/117 (0.00%)  0
Nervous system disorders         
Amyotrophic lateral sclerosis  1  0/115 (0.00%)  0 0/112 (0.00%)  0 0/113 (0.00%)  0 1/117 (0.85%)  1
Dizziness  1  0/115 (0.00%)  0 0/112 (0.00%)  0 1/113 (0.88%)  2 0/117 (0.00%)  0
Muscle contractions involuntary  1  0/115 (0.00%)  0 1/112 (0.89%)  1 0/113 (0.00%)  0 0/117 (0.00%)  0
Transient ischaemic attack  1  0/115 (0.00%)  0 0/112 (0.00%)  0 0/113 (0.00%)  0 1/117 (0.85%)  1
Renal and urinary disorders         
Urinary retention  1  0/115 (0.00%)  0 0/112 (0.00%)  0 1/113 (0.88%)  1 0/117 (0.00%)  0
Reproductive system and breast disorders         
Prostatomegaly  1  0/115 (0.00%)  0 0/112 (0.00%)  0 0/113 (0.00%)  0 1/117 (0.85%)  1
Haemorrhagic ovarian cyst  1  1/115 (0.87%)  1 0/112 (0.00%)  0 0/113 (0.00%)  0 0/117 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  0/115 (0.00%)  0 1/112 (0.89%)  1 1/113 (0.88%)  1 1/117 (0.85%)  1
Respiratory distress  1  0/115 (0.00%)  0 0/112 (0.00%)  0 1/113 (0.88%)  1 0/117 (0.00%)  0
Pneumonia aspiration  1  2/115 (1.74%)  2 0/112 (0.00%)  0 0/113 (0.00%)  0 0/117 (0.00%)  0
Pulmonary embolism  1  2/115 (1.74%)  2 0/112 (0.00%)  0 0/113 (0.00%)  0 0/117 (0.00%)  0
Vascular disorders         
Jugular vein thrombosis  1  1/115 (0.87%)  1 0/112 (0.00%)  0 0/113 (0.00%)  0 0/117 (0.00%)  0
Subclavian vein thrombosis  1  1/115 (0.87%)  1 0/112 (0.00%)  0 0/113 (0.00%)  0 0/117 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Reldesemtiv 150 mg Twice Daily Reldesemtiv 300 mg Twice Daily Reldesemtiv 450 mg Twice Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   95/115 (82.61%)      99/112 (88.39%)      97/113 (85.84%)      107/117 (91.45%)    
Gastrointestinal disorders         
Nausea  1  14/115 (12.17%)  16 10/112 (8.93%)  13 13/113 (11.50%)  14 22/117 (18.80%)  23
Constipation  1  5/115 (4.35%)  5 7/112 (6.25%)  8 13/113 (11.50%)  15 10/117 (8.55%)  10
Diarrhoea  1  8/115 (6.96%)  8 12/112 (10.71%)  15 6/113 (5.31%)  6 4/117 (3.42%)  4
Dry mouth  1  2/115 (1.74%)  2 2/112 (1.79%)  2 6/113 (5.31%)  6 1/117 (0.85%)  1
General disorders         
Fatigue  1  12/115 (10.43%)  14 14/112 (12.50%)  14 19/113 (16.81%)  20 20/117 (17.09%)  24
Infections and infestations         
Viral upper respiratory tract infection  1  9/115 (7.83%)  9 6/112 (5.36%)  6 10/113 (8.85%)  10 9/117 (7.69%)  9
Urinary tract infection  1  8/115 (6.96%)  9 3/112 (2.68%)  5 5/113 (4.42%)  5 5/117 (4.27%)  7
Upper respiratory tract infection  1  3/115 (2.61%)  4 7/112 (6.25%)  7 1/113 (0.88%)  1 1/117 (0.85%)  1
Injury, poisoning and procedural complications         
Contusion  1  15/115 (13.04%)  28 8/112 (7.14%)  15 14/113 (12.39%)  15 17/117 (14.53%)  26
Post-traumatic pain  1  2/115 (1.74%)  2 6/112 (5.36%)  8 8/113 (7.08%)  11 6/117 (5.13%)  6
Skin abrasion  1  5/115 (4.35%)  7 8/112 (7.14%)  10 3/113 (2.65%)  4 5/117 (4.27%)  7
Investigations         
Cystatin C increased  1  2/115 (1.74%)  2 7/112 (6.25%)  7 9/113 (7.96%)  9 20/117 (17.09%)  22
Glomerular filtration rate decreased  1  1/115 (0.87%)  1 6/112 (5.36%)  6 6/113 (5.31%)  6 10/117 (8.55%)  11
Alanine aminotransferase increased  1  1/115 (0.87%)  1 2/112 (1.79%)  2 5/113 (4.42%)  6 11/117 (9.40%)  14
Aspartate aminotransferase increased  1  1/115 (0.87%)  1 2/112 (1.79%)  2 3/113 (2.65%)  3 9/117 (7.69%)  11
Metabolism and nutrition disorders         
Decreased appetite  1  4/115 (3.48%)  4 3/112 (2.68%)  3 7/113 (6.19%)  7 7/117 (5.98%)  8
Dehydration  1  0/115 (0.00%)  0 1/112 (0.89%)  1 6/113 (5.31%)  6 6/117 (5.13%)  7
Musculoskeletal and connective tissue disorders         
Arthralgia  1  2/115 (1.74%)  2 8/112 (7.14%)  9 4/113 (3.54%)  5 8/117 (6.84%)  10
Pain in extremity  1  5/115 (4.35%)  6 1/112 (0.89%)  1 3/113 (2.65%)  3 6/117 (5.13%)  7
Muscle spasms  1  1/115 (0.87%)  1 6/112 (5.36%)  7 2/113 (1.77%)  2 1/117 (0.85%)  1
Nervous system disorders         
Headache  1  15/115 (13.04%)  18 16/112 (14.29%)  18 16/113 (14.16%)  19 12/117 (10.26%)  13
Dizziness  1  11/115 (9.57%)  13 8/112 (7.14%)  12 11/113 (9.73%)  13 7/117 (5.98%)  7
Skin and subcutaneous tissue disorders         
Pruritus  1  2/115 (1.74%)  4 1/112 (0.89%)  1 2/113 (1.77%)  3 6/117 (5.13%)  6
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: MD Cytokinetics
Organization: Cytokinetics, Inc.
Phone: 650-624-2929
EMail: medicalaffairs@cytokinetics.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Cytokinetics
ClinicalTrials.gov Identifier: NCT03160898    
Other Study ID Numbers: CY 5022
First Submitted: May 12, 2017
First Posted: May 19, 2017
Results First Submitted: August 5, 2020
Results First Posted: September 11, 2020
Last Update Posted: September 11, 2020