Registered outcomes12

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

1 to 12 of 12

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.
Secondary	Reldesemtiv Maximum Observed Plasma Concentration (Cmax)	End of 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
Secondary	Reldesemtiv Area Under the Plasma Concentration-time Curve From 0 to 12 Hours (AUC0-12)	End of 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

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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