Trial · NCT03238235
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline to Visit 11 in Total Fibrosis (%) on Log Scale, Comparing the Histology of Muscle Biopsies | after 12 months of treatment (at Visit 11) | Intent-To-Treat Analysis (ITT) Set: all patients assigned treatment by randomization who received at least one dose of study medication. According to the intent to treat principle, patients were analyzed according to the treatment assigned. Efficacy analyses were performed on the ITT set. | log[percentage of total fibrosis] | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Visit 11 in the Percentage of Fat Fraction of Vastus Lateralis and Soleus | after 12 months of treatment (at Visit 11) | Intent-To-Treat Analysis (ITT) Set: all patients assigned treatment by randomization who received at least one dose of study medication. According to the intent to treat principle, patients were analyzed according to the treatment assigned. Efficacy analyses were performed on the ITT set. | log[percentage of fat in muscle] | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Visit 11 in the Percentage of Fat Fraction of Lower Limb Muscles | after 12 months of treatment (at Visit 11) | Intent-To-Treat Analysis (ITT) Set: all patients assigned treatment by randomization who received at least one dose of study medication. According to the intent to treat principle, patients were analyzed according to the treatment assigned. Efficacy analyses were performed on the ITT set. | percentage of fat in muscle | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Visit 11 in Cross-sectional Area (CSA), in cm2 of Lower Limb Muscles | after 12 months of treatment (Visit 11) | Intent-To-Treat Analysis (ITT) Set: all patients assigned treatment by randomization who received at least one dose of study medication. According to the intent to treat principle, patients were analyzed according to the treatment assigned. Efficacy analyses were performed on the ITT set. | centimeters^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Visit 11 in Contractile Area of Lower Limb Muscles (MRI) | after 12 months of treatment | Intent-To-Treat Analysis (ITT) Set: all patients assigned treatment by randomization who received at least one dose of study medication. According to the intent to treat principle, patients were analyzed according to the treatment assigned. Efficacy analyses were performed on the ITT set. | centimeters^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Visit 11 in Biopsy Histology Parameters: CSA by Type (I or II Fibers), Total CSA | After 12 months of treatment (Visit 11) | Intent-To-Treat Analysis (ITT) Set: all patients assigned treatment by randomization who received at least one dose of study medication. According to the intent to treat principle, patients were analyzed according to the treatment assigned. Efficacy analyses were performed on the ITT set. | micrometers^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Visit 11 in Percentage for the Following Histology Parameters: Fibers With Nuclear Centralizations (%), Total Number of Fibers (%), Regenerative Fibers (%). | after 12 months of treatment (Visit 11) | Intent-To-Treat Analysis (ITT) Set: all patients assigned treatment by randomization who received at least one dose of study medication. According to the intent to treat principle, patients were analyzed according to the treatment assigned. | percentage of fibers | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Visit 11 in Percentage for the Biopsy Histology Parameter MFA(%) | after 12 months of treatment (Visit 11) | Intent-To-Treat Analysis (ITT) Set: all patients assigned treatment by randomization who received at least one dose of study medication. According to the intent to treat principle, patients were analyzed according to the treatment assigned. Efficacy analyses were performed on the ITT set. | percentage of muscle fiber area | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Visit 11 in Percentage for the Biopsy Histology Parameters Adipose Tissue (%) | after 12 months of treatment (Visit 11) | Intent-To-Treat Analysis (ITT) Set: all patients assigned treatment by randomization who received at least one dose of study medication. According to the intent to treat principle, patients were analyzed according to the treatment assigned. Efficacy analyses were performed on the ITT set. | percentage of total tissue | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Visit 11 in Other Histological Structures | after 12 months of treatment (Visit 11) | Intent-To-Treat Analysis (ITT) Set: all patients assigned treatment by randomization who received at least one dose of study medication. According to the intent to treat principle, patients were analyzed according to the treatment assigned. Efficacy analyses were performed on the ITT set. | percentage of total tissue | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Visit 11 in Motor Function Measurement (MFM, Expressed as Log Least Square Mean) | after 12 months of treatment (Visit 11) | Intent-To-Treat Analysis (ITT) Set: all patients assigned treatment by randomization who received at least one dose of study medication. According to the intent to treat principle, patients were analyzed according to the treatment assigned. Efficacy analyses were performed on the ITT set. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Visit 11 in Time Function Test (TFT): Time to Walk/Run 10 Meters | after 12 months of treatment (Visit 11) | Intent-To-Treat Analysis (ITT) Set: all patients assigned treatment by randomization who received at least one dose of study medication. According to the intent to treat principle, patients were analyzed according to the treatment assigned. Efficacy analyses were performed on the ITT set. | sec | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Visit 11 in Time Function Test (TFT) Via Time to Climb 4 Standard Steps | after 12 months of treatment (Visit 11) | Intent-To-Treat Analysis (ITT) Set: all patients assigned treatment by randomization who received at least one dose of study medication. According to the intent to treat principle, patients were analyzed according to the treatment assigned. Efficacy analyses were performed on the ITT set. Please consider the data are showed in Log Least Square Mean | sec | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Visit 11 in Time Function Test Via Time to Rise From Floor | after 12 months of treatment (Visit 11) | Intent-To-Treat Analysis (ITT) Set: all patients assigned treatment by randomization who received at least one dose of study medication. According to the intent to treat principle, patients were analyzed according to the treatment assigned. Efficacy analyses were performed on the ITT set. | sec | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Visit 11 in Distance Performed Via 6-minute Walk/Run Test (6MWT, Expressed as Log Least Square Mean) | after 12 months of treatment (Visit 11) | Intent-To-Treat Analysis (ITT) Set: all patients assigned treatment by randomization who received at least one dose of study medication. According to the intent to treat principle, patients were analyzed according to the treatment assigned. Efficacy analyses were performed on the ITT set. | log [meters] | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients With < 10% Worsening in 6MWT After 12 Months of Treatment. | after 12 months of treatment (Visit 11) | Intent-To-Treat Analysis (ITT) Set: all patients assigned treatment by randomization who received at least one dose of study medication. According to the intent to treat principle, patients were analyzed according to the treatment assigned. Patients with missing data such that \<10% worsening cannot be determined are included in the analysis as having worsened | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Count of Participant Who Lose Ambulation During the Study (From Baseline to Month 12) | from baseline to the end of month 12 | Intent-To-Treat Analysis (ITT) Set: all patients assigned treatment by randomization who received at least one dose of study medication. According to the intent to treat principle, patients were analyzed according to the treatment assigned. Efficacy analyses were performed on the ITT set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Who Fell During the 6MWT | after 12 months of treatment (Visit 11) | Intent-To-Treat Analysis (ITT) Set: all patients assigned treatment by randomization who received at least one dose of study medication. According to the intent to treat principle, patients were analyzed according to the treatment assigned. Efficacy analyses were performed on the ITT set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline to Visit 11 in Muscle Strength Evaluated by Knee Extension, Elbow Flexion | after 12 months of treatment (Visit 11) | Intent-To-Treat Analysis (ITT) Set: all patients assigned treatment by randomization who received at least one dose of study medication. According to the intent to treat principle, patients were analyzed according to the treatment assigned. Efficacy analyses were performed on the ITT set. | Newton | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Changes From Baseline to Visit 11 in Quality of Life (QoL, Assessed by the 36-item Short Form Survey [SF36]) | after 12 months of treatment (Visit 11) | Intent-To-Treat Analysis (ITT) Set: all patients assigned treatment by randomization who received at least one dose of study medication. According to the intent to treat principle, patients were analyzed according to the treatment assigned. Efficacy analyses were performed on the ITT set. | units on a scale | MEAN |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT03238235/outcomes