Trial · NCT03039686
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Baseline for the North Star Ambulatory Assessment (NSAA) Total Score | Baseline | Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in the North Star Ambulatory Assessment (NSAA) Total Score at Week 48 | Baseline, Week 48 | Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment. MMRM analysis included all participants at baseline and the following number of participants by Week 48: Placebo n=30, Low Dose n=29, High Dose n=33. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Baseline Time for 4 Stair Climb | Baseline | Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment. | seconds (secs) | MEAN |
| SECONDARY | Change From Baseline at Week 48 in 4 Stair Climb Velocity (4SCV) | Baseline, Week 48 | Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment. MMRM analysis included all participants at baseline and the following number of participants by Week 48: Placebo n=30, Low Dose n=29, High Dose n=33. | stairs/sec | LEAST_SQUARES_MEAN |
| SECONDARY | Baseline for the Time to Stand From Supine | Baseline | Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment. | secs | MEAN |
| SECONDARY | Change From Baseline at Week 48 in Stand From Supine Velocity | Baseline, Week 48 | Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment. MMRM analysis included all participants at baseline and the following number of participants by Week 48: Placebo n=28, Low Dose n=28, High Dose n=32. | 1/sec | LEAST_SQUARES_MEAN |
| SECONDARY | Baseline Time for 10 Meter Walk/Run | Baseline | Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment. | secs | MEAN |
| SECONDARY | Change From Baseline at Week 48 in 10 M Walk/Run Velocity | Baseline, Week 48 | Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment. MMRM analysis included all participants at baseline and the following number of participants by Week 48: Placebo n=30, Low Dose n=29, High Dose n=31. | m/sec | LEAST_SQUARES_MEAN |
| SECONDARY | Baseline for the Pediatric Outcome Data Collection Instrument (PODCI) Transfer and Basic Mobility Subscale | Baseline | Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment. | score on a scale | MEAN |
| SECONDARY | Change From Baseline at Week 48 in Pediatric Outcome Data Collection Instrument (PODCI) Transfer and Basic Mobility Subscale | Baseline, Week 48 | Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment. MMRM analysis included all participants at baseline and the following number of participants by Week 48: Placebo n=31, Low Dose n=29, High Dose n=34. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 48 in Proximal Lower Extremity Flexor Strength | Baseline, Week 48 | Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment. Number analyzed is the number of participants with data available for analyses at the given timepoint. | kilogram (kg) | MEAN |
| SECONDARY | Baseline for the 6 Minute Walk Distance (6MWD) | Baseline | Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment. | meters (m) | MEAN |
| SECONDARY | Change From Baseline at Week 48 in 6 Minute Walk Distance (6MWD) | Baseline, Week 48 | Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment. MMRM analysis included all participants at baseline and the following number of participants by Week 48: Placebo n=29, Low Dose n=25, High Dose n=31. | meters (m) | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants for Each Clinical Global Impression of Change (CGI-C) Assessment Status at Week 48 | Baseline, Week 48 | Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment. Included in the analysis are only those subjects for whom an efficacy assessment was completed at Week 48. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline at Week 48 in 95th Percentile Stride Velocity | Baseline, Week 48 | Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment. | m/sec | MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) | During DB period (48 weeks) and Whole study (up to approximately 34 months) | Safety population included all enrolled participants who received at least 1 dose of study therapy. Data are presented for the arms in the DB period as well as for all RO7239361-treated participants in the whole study. | participants | NUMBER |
| SECONDARY | Number of Participants With AEs Leading to Discontinuation | During DB period (48 weeks) and Whole study (up to approximately 34 months) | Safety population included all enrolled participants who received at least 1 dose of study therapy. Data are presented for the arms in the DB period as well as for all RO7239361-treated participants in the whole study. | participants | NUMBER |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03039686/outcomes