Trial Outcomes & Findings for A Study of CK-2127107 in Patients With Spinal Muscular Atrophy (NCT NCT02644668)

Last Updated: 2020-08-31

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

70 participants

Primary outcome timeframe

baseline and 8 weeks

Results posted on

2020-08-31

Participant Flow

Patients with SMA were enrolled at 18 sites in Canada and the United States. The first patient was enrolled on 14 January 2016 and the last patient completed on 31 May 2018.

Eligible patients were male or female, ≥12 y of age and had a genetically confirmed diagnosis of SMA. Ambulatory patients were able to walk ≥50 m in 6 min; and non-ambulatory patients were able to tolerate upright sitting with support for 3 h. Patients had an FVC \>20% predicted, an HFMS-E score ≥10 and ≤54, and elbow and knee flexion ≤90 degrees.

Participant milestones

Participant milestones
Measure	Placebo Patients randomized to this treatment arm received a placebo suspension twice daily for 8 weeks. Placebo: Granules for oral suspension (placebo)	Reldesemtiv 150 mg Twice Daily Patient randomized to this treatment arm received reldesemtiv suspension at a dose of 150 mg, twice daily for 8 weeks. Reldesemtiv 150 mg: Granules for oral suspension, 18.7% reldesemtiv	Reldesemtiv 450 mg Twice Daily Patients randomized to this treatment arm received reldesemtiv suspension at a dose of 450 mg, twice daily for 8 weeks. Reldesemtiv 450 mg: Granules for oral suspension, 56.0% reldesemtiv
Overall Study STARTED	26	24	20
Overall Study COMPLETED	24	24	17
Overall Study NOT COMPLETED	2	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Patients randomized to this treatment arm received a placebo suspension twice daily for 8 weeks. Placebo: Granules for oral suspension (placebo)	Reldesemtiv 450 mg Twice Daily Patients randomized to this treatment arm received reldesemtiv suspension at a dose of 450 mg, twice daily for 8 weeks. Reldesemtiv 450 mg: Granules for oral suspension, 56.0% reldesemtiv
Overall Study Adverse Event	2	1
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=26 Participants Patients randomized to this treatment arm received a placebo suspension twice daily for 8 weeks.	Reldesemtiv 150 mg Twice Daily n=24 Participants Patient randomized to this treatment arm received reldesemtiv suspension at a dose of 150 mg, twice daily for 8 weeks.	Reldesemtiv 450 mg Twice Daily n=20 Participants Patients randomized to this treatment arm received reldesemtiv suspension at a dose of 450 mg, twice daily for 8 weeks.	Total n=70 Participants Total of all reporting groups
Age, Continuous	28.5 years STANDARD_DEVIATION 16.03 • n=5 Participants	27.8 years STANDARD_DEVIATION 11.96 • n=7 Participants	32.6 years STANDARD_DEVIATION 17.92 • n=5 Participants	29.4 years STANDARD_DEVIATION 15.27 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	29 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	14 Participants n=7 Participants	12 Participants n=5 Participants	41 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	23 Participants n=7 Participants	18 Participants n=5 Participants	63 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Time since SMA symptom onset	302.5 months STANDARD_DEVIATION 170.11 • n=5 Participants	246.8 months STANDARD_DEVIATION 105.93 • n=7 Participants	299.8 months STANDARD_DEVIATION 174.32 • n=5 Participants	282.6 months STANDARD_DEVIATION 152.56 • n=4 Participants
Time since genetically confirmed diagnosis	139.2 months STANDARD_DEVIATION 75.09 • n=5 Participants	138.8 months STANDARD_DEVIATION 81.45 • n=7 Participants	101.4 months STANDARD_DEVIATION 82.27 • n=5 Participants	128.2 months STANDARD_DEVIATION 80.06 • n=4 Participants

PRIMARY outcome

Timeframe: baseline and 8 weeks

Population: The analysis population includes patients who received at least 1 dose of reldesemtiv and had results from the relevant outcome measure at Week 8.

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Patients randomized to this treatment arm received a placebo suspension twice daily for 8 weeks.	Reldesemtiv 150 mg Twice Daily n=24 Participants Patient randomized to this treatment arm received reldesemtiv suspension at a dose of 150 mg, twice daily for 8 weeks.	Reldesemtiv 450 mg Twice Daily n=18 Participants Patients randomized to this treatment arm received reldesemtiv suspension at a dose of 450 mg, twice daily for 8 weeks.
Change From Baseline to Week 8 in Forced Vital Capacity (FVC)	-0.02 liters Standard Error 0.042	-0.03 liters Standard Error 0.043	-0.07 liters Standard Error 0.050

PRIMARY outcome

Timeframe: baseline and 8 weeks

Population: The analysis population includes patients who received at least 1 dose of reldesemtiv and had results from the relevant outcome measure at Week 8.

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.

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Patients randomized to this treatment arm received a placebo suspension twice daily for 8 weeks.	Reldesemtiv 150 mg Twice Daily n=24 Participants Patient randomized to this treatment arm received reldesemtiv suspension at a dose of 150 mg, twice daily for 8 weeks.	Reldesemtiv 450 mg Twice Daily n=18 Participants Patients randomized to this treatment arm received reldesemtiv suspension at a dose of 450 mg, twice daily for 8 weeks.
Change From Baseline to Week 8 in Maximum Inspiratory Pressure (MIP)	-2.62 cm H2O Standard Error 3.317	-5.56 cm H2O Standard Error 3.401	-1.63 cm H2O Standard Error 3.901

PRIMARY outcome

Timeframe: baseline and 8 weeks

Population: The analysis population includes patients who received at least 1 dose of reldesemtiv and had results from the relevant outcome measure at Week 8.

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.

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Patients randomized to this treatment arm received a placebo suspension twice daily for 8 weeks.	Reldesemtiv 150 mg Twice Daily n=24 Participants Patient randomized to this treatment arm received reldesemtiv suspension at a dose of 150 mg, twice daily for 8 weeks.	Reldesemtiv 450 mg Twice Daily n=18 Participants Patients randomized to this treatment arm received reldesemtiv suspension at a dose of 450 mg, twice daily for 8 weeks.
Change From Baseline to Week 8 in Maximum Expiratory Pressure (MEP)	-4.22 cm H2O Standard Error 3.843	7.47 cm H2O Standard Error 3.941	8.93 cm H2O Standard Error 4.517

PRIMARY outcome

Timeframe: baseline and 8 weeks

Population: The analysis population includes patients who received at least 1 dose of reldesemtiv and had results from the relevant outcome measure at Week 8.

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).

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Patients randomized to this treatment arm received a placebo suspension twice daily for 8 weeks.	Reldesemtiv 150 mg Twice Daily n=24 Participants Patient randomized to this treatment arm received reldesemtiv suspension at a dose of 150 mg, twice daily for 8 weeks.	Reldesemtiv 450 mg Twice Daily n=18 Participants Patients randomized to this treatment arm received reldesemtiv suspension at a dose of 450 mg, twice daily for 8 weeks.
Muscle Strength Mega-Score at Week 8	14.34 percent change Standard Error 5.298	9.76 percent change Standard Error 5.393	-0.88 percent change Standard Error 6.247

PRIMARY outcome

Timeframe: baseline and 8 weeks

Population: The analysis population includes patients who received at least 1 dose of reldesemtiv and had results from the relevant outcome measure at Week 8.

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.

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Patients randomized to this treatment arm received a placebo suspension twice daily for 8 weeks.	Reldesemtiv 150 mg Twice Daily n=22 Participants Patient randomized to this treatment arm received reldesemtiv suspension at a dose of 150 mg, twice daily for 8 weeks.	Reldesemtiv 450 mg Twice Daily n=18 Participants Patients randomized to this treatment arm received reldesemtiv suspension at a dose of 450 mg, twice daily for 8 weeks.
Change From Baseline to Week 8 in the Hammersmith Functional Motor Scale-Expanded (HFMS-E)	1.40 score on a scale Standard Error 0.637	1.02 score on a scale Standard Error 0.675	0.39 score on a scale Standard Error 0.748

PRIMARY outcome

Timeframe: baseline and 8 weeks

Population: The analysis population includes patients who received at least 1 dose of reldesemtiv and had results from the relevant outcome measure at Week 8.

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.

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Patients randomized to this treatment arm received a placebo suspension twice daily for 8 weeks.	Reldesemtiv 150 mg Twice Daily n=24 Participants Patient randomized to this treatment arm received reldesemtiv suspension at a dose of 150 mg, twice daily for 8 weeks.	Reldesemtiv 450 mg Twice Daily n=18 Participants Patients randomized to this treatment arm received reldesemtiv suspension at a dose of 450 mg, twice daily for 8 weeks.
Change From Baseline to Week 8 in Revised Upper Limb Module (RULM)	0.54 score on a scale Standard Error 0.397	1.15 score on a scale Standard Error 0.406	0.43 score on a scale Standard Error 0.468

PRIMARY outcome

Timeframe: baseline and 8 weeks

Population: This test was evaluated in ambulatory patients only.

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.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Patients randomized to this treatment arm received a placebo suspension twice daily for 8 weeks.	Reldesemtiv 150 mg Twice Daily n=10 Participants Patient randomized to this treatment arm received reldesemtiv suspension at a dose of 150 mg, twice daily for 8 weeks.	Reldesemtiv 450 mg Twice Daily n=4 Participants Patients randomized to this treatment arm received reldesemtiv suspension at a dose of 450 mg, twice daily for 8 weeks.
Change From Baseline to Week 8 in the TUG Test	0.24 seconds Standard Error 1.837	-0.54 seconds Standard Error 1.708	-2.87 seconds Standard Error 2.675

PRIMARY outcome

Timeframe: baseline and 8 weeks

Population: This test was evaluated in ambulatory patients only.

The 6MWT measured the distance (in meters) a patient walked in 6 minutes.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Patients randomized to this treatment arm received a placebo suspension twice daily for 8 weeks.	Reldesemtiv 150 mg Twice Daily n=12 Participants Patient randomized to this treatment arm received reldesemtiv suspension at a dose of 150 mg, twice daily for 8 weeks.	Reldesemtiv 450 mg Twice Daily n=6 Participants Patients randomized to this treatment arm received reldesemtiv suspension at a dose of 450 mg, twice daily for 8 weeks.
Change From Baseline to Week 8 in the 6MWT	1.39 meters Standard Error 7.692	9.11 meters Standard Error 6.826	26.28 meters Standard Error 9.641

PRIMARY outcome

Timeframe: 8 weeks

Population: The analysis population includes patients who received at least 1 dose of reldesemtiv and had results from the relevant outcome measure at Week 8.

Patients assessed whether they felt the same, better, or worse than prior to dosing on Day 1.

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Patients randomized to this treatment arm received a placebo suspension twice daily for 8 weeks.	Reldesemtiv 150 mg Twice Daily n=24 Participants Patient randomized to this treatment arm received reldesemtiv suspension at a dose of 150 mg, twice daily for 8 weeks.	Reldesemtiv 450 mg Twice Daily n=18 Participants Patients randomized to this treatment arm received reldesemtiv suspension at a dose of 450 mg, twice daily for 8 weeks.
Patient Global Assessment at the End of Week 8 Better than pre-dose	12 Participants	7 Participants	7 Participants
Patient Global Assessment at the End of Week 8 Same as pre-dose	13 Participants	15 Participants	11 Participants
Patient Global Assessment at the End of Week 8 Worse than pre-dose	0 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: The analysis population includes patients who received at least 1 dose of reldesemtiv and had results from the relevant outcome measure at Week 8.

The Investigator assessed whether patient appeared the same, better, or worse than prior to dosing on Day 1.

Outcome measures

Outcome measures
Measure	Placebo n=24 Participants Patients randomized to this treatment arm received a placebo suspension twice daily for 8 weeks.	Reldesemtiv 150 mg Twice Daily n=24 Participants Patient randomized to this treatment arm received reldesemtiv suspension at a dose of 150 mg, twice daily for 8 weeks.	Reldesemtiv 450 mg Twice Daily n=17 Participants Patients randomized to this treatment arm received reldesemtiv suspension at a dose of 450 mg, twice daily for 8 weeks.
Investigator Global Assessment at the End of Week 8 Better than pre-dose	6 Participants	7 Participants	6 Participants
Investigator Global Assessment at the End of Week 8 Same as pre-dose	18 Participants	17 Participants	11 Participants
Investigator Global Assessment at the End of Week 8 Worse than pre-dose	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: End of Week 8

Population: The analysis population includes all patients who had an evaluable reldesemtiv Cmax value at Week 8.

Determined by evaluation of reldesemtiv plasma concentrations from blood samples collected prior to dosing and at 1, 3, and 6 hours following dosing

Outcome measures

Outcome measures
Measure	Placebo n=23 Participants Patients randomized to this treatment arm received a placebo suspension twice daily for 8 weeks.	Reldesemtiv 150 mg Twice Daily n=15 Participants Patient randomized to this treatment arm received reldesemtiv suspension at a dose of 150 mg, twice daily for 8 weeks.	Reldesemtiv 450 mg Twice Daily Patients randomized to this treatment arm received reldesemtiv suspension at a dose of 450 mg, twice daily for 8 weeks.
Reldesemtiv Maximum Observed Plasma Concentration (Cmax)	1.40 microgram/milliliter Geometric Coefficient of Variation 43.18	3.34 microgram/milliliter Geometric Coefficient of Variation 48.77	—

SECONDARY outcome

Timeframe: End of Week 8

Population: The analysis population includes patients who had an evaluable reldesemtiv AUC0-12 value at Week 8.

Determined by evaluation of reldesemtiv plasma concentrations from blood samples collected prior to dosing and at 1, 3, and 6 hours following dosing

Outcome measures

Outcome measures
Measure	Placebo n=23 Participants Patients randomized to this treatment arm received a placebo suspension twice daily for 8 weeks.	Reldesemtiv 150 mg Twice Daily n=15 Participants Patient randomized to this treatment arm received reldesemtiv suspension at a dose of 150 mg, twice daily for 8 weeks.	Reldesemtiv 450 mg Twice Daily Patients randomized to this treatment arm received reldesemtiv suspension at a dose of 450 mg, twice daily for 8 weeks.
Reldesemtiv Area Under the Plasma Concentration-time Curve From 0 to 12 Hours (AUC0-12)	9.0 hour x microgram/milliliter Geometric Coefficient of Variation 49.38	25.0 hour x microgram/milliliter Geometric Coefficient of Variation 52.19	—

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Reldesemtiv 150 mg Twice Daily

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Reldesemtiv 450 mg Twice Daily

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=26 participants at risk Patients randomized to this treatment arm received a placebo suspension twice daily for 8 weeks.	Reldesemtiv 150 mg Twice Daily n=24 participants at risk Patient randomized to this treatment arm received reldesemtiv suspension at a dose of 150 mg, twice daily for 8 weeks.	Reldesemtiv 450 mg Twice Daily n=20 participants at risk Patients randomized to this treatment arm received reldesemtiv suspension at a dose of 450 mg, twice daily for 8 weeks.
Cardiac disorders Myocarditis	0.00% 0/26 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).	4.2% 1/24 • Number of events 1 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).	0.00% 0/20 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).
General disorders Facial pain	0.00% 0/26 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).	4.2% 1/24 • Number of events 1 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).	0.00% 0/20 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).
Infections and infestations Gastroenteritis Escherichia coli	0.00% 0/26 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).	4.2% 1/24 • Number of events 1 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).	0.00% 0/20 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).
Infections and infestations Gastroenteritis salmonella	0.00% 0/26 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).	4.2% 1/24 • Number of events 1 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).	0.00% 0/20 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).
Injury, poisoning and procedural complications Traumatic fracture	0.00% 0/26 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).	0.00% 0/24 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).	5.0% 1/20 • Number of events 1 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).
Nervous system disorders Hypoaesthesia	0.00% 0/26 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).	4.2% 1/24 • Number of events 1 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).	0.00% 0/20 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).
Investigations Blood creatine phosphokinase increased	0.00% 0/26 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).	0.00% 0/24 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).	5.0% 1/20 • Number of events 1 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).
Investigations Aspartate aminotransferase increased	0.00% 0/26 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).	0.00% 0/24 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).	5.0% 1/20 • Number of events 1 • Adverse events (AEs) were collected over approximately 12 weeks: from administration of the first dose of study drug through the treatment period [8 weeks] and through the follow-up period [4 weeks after the last dose of study drug]).

Other adverse events

Additional Information

MD Cytokinetics

Cytokinetics, Inc.

Phone: 650-624-2929

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place