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Trial · NCT02851797

Results by group86

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

OutcomeGroupCategoryValueSpreadUnits
Mean Change From Baseline in 4 Standard Stairs (4SC) Climb After 18 Months of TreatmentGivinostat1.27Standard Error 0.040seconds
Mean Change From Baseline in 4 Standard Stairs (4SC) Climb After 18 Months of TreatmentPlacebo1.48Standard Error 0.058seconds
Mean Change From Baseline in Time to Rise From Floor After 18 Months of TreatmentGivinostat9.3395% Confidence Interval 5.821 to 12.838seconds
Mean Change From Baseline in Time to Rise From Floor After 18 Months of TreatmentPlacebo12.6195% Confidence Interval 7.491 to 17.724seconds
Mean Change From Baseline in the Six-minute Walking Test (6MWT) After 18 Months of TreatmentGivinostat-38.4395% Confidence Interval -50.704 to -26.153meters
Mean Change From Baseline in the Six-minute Walking Test (6MWT) After 18 Months of TreatmentPlacebo-48.3895% Confidence Interval -66.288 to -30.482meters
Mean Change From Baseline in Total North Star Ambulatory Assessment (NSAA) Score After 18 Months of TreatmentGivinostat-2.6695% Confidence Interval -3.563 to -1.759score on a scale
Mean Change From Baseline in Total North Star Ambulatory Assessment (NSAA) Score After 18 Months of TreatmentPlacebo-4.5895% Confidence Interval -5.891 to -3.260score on a scale
Cumulative Loss of Function on the NSAAGivinostat3.4295% Confidence Interval 2.692 to 4.334cumulative number of failures
Cumulative Loss of Function on the NSAAPlacebo5.5695% Confidence Interval 4.002 to 7.715cumulative number of failures
Mean Change From Baseline of Muscle Strength Normalized OvertimeGivinostatOverall knee extension-0.3295% Confidence Interval -0.441 to -0.197Newtons/kg
Mean Change From Baseline of Muscle Strength Normalized OvertimePlaceboOverall knee extension-0.5095% Confidence Interval -0.681 to -0.328Newtons/kg
Mean Change From Baseline of Muscle Strength Normalized OvertimeGivinostatOverall elbow flexion-0.1095% Confidence Interval -0.174 to -0.031Newtons/kg
Mean Change From Baseline of Muscle Strength Normalized OvertimePlaceboOverall elbow flexion-0.1995% Confidence Interval -0.292 to -0.085Newtons/kg
Mean Change From Baseline in Vastus Lateralis Muscle Fat Fraction (VL MFF) at 18 MonthsGivinostat7.6395% Confidence Interval 6.098 to 9.172percentage of fat
Mean Change From Baseline in Vastus Lateralis Muscle Fat Fraction (VL MFF) at 18 MonthsPlacebo10.5695% Confidence Interval 8.331 to 12.783percentage of fat
Number of Subjects Experiencing Treatment-emergent AEs (TEAEs), Serious AEs (SAEs), Mild TEAE Moderate TEAE, Severe TEAEGivinostatSubjects with TEAE112Participants
Number of Subjects Experiencing Treatment-emergent AEs (TEAEs), Serious AEs (SAEs), Mild TEAE Moderate TEAE, Severe TEAEPlaceboSubjects with TEAE57Participants
Number of Subjects Experiencing Treatment-emergent AEs (TEAEs), Serious AEs (SAEs), Mild TEAE Moderate TEAE, Severe TEAEGivinostatSubjects with serious AE8Participants
Number of Subjects Experiencing Treatment-emergent AEs (TEAEs), Serious AEs (SAEs), Mild TEAE Moderate TEAE, Severe TEAEPlaceboSubjects with serious AE2Participants

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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