Trial · NCT00977665
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 48/Termination Visit in the Total Unified Multiple System Atrophy Rating Scale (UMSARS Part I and II) | Day 0 (baseline), Week 48 | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment were included in the principal efficacy analysis, according to the treatment group to which they were originally assigned. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impression Improvement (CGI-I) at Week 48/Termination Visit | Week 48 | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 24 in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score | Day 0 (baseline), Week 24 | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #7 Regarding Ambulation | up to week 48 | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | percentage of participants | NUMBER |
| SECONDARY | Mean Score of the Composite Autonomic Symptom Scale Select (COMPASS_Select Change) at Week 48/Termination Visit | 48 weeks | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 48/Termination Visit in the Multiple System Atrophy (MSA) Health-related Quality of Life (QoL) Scale | Day 0 (baseline), Week 48 | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of Progression in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score From Baseline to Weeks 12-48 | Day 0 (baseline), Weeks 12-48 | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | units on a scale/week | MEAN |
| SECONDARY | Change From Baseline to Week 48 or Termination in UMSARS Subscores for Parts I, II and IV | Day 0 (baseline), Week 48 or termination visit | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 12 in Total UMSARS Score for Symptomatic Effect | Day 0 (baseline), Week 12 | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | units on a scale | MEAN |
| SECONDARY | Estimates for Time to Change in Anti-Parkinsonian or Anti-Orthostatis Hypotension Medications | Day 0 (baseline) to Week 48 or termination visit | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | days | MEDIAN |
| SECONDARY | Change From Baseline to Week 48 or Termination in the Montreal Cognitive Assessment Scale (MoCA) Scale | Day 0 (baseline), Week 48 or termination visit | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #1 (Speech Impairment), Question #2 (Swallowing Impairment) and Question #8 (Falling) | up to week 48 | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Week 48 or Termination in the Beck Depression Inventory Scale (BDI-II) | Day 0 (baseline), Week 48 or termination visit | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Total Number of Falls During the Study | Day 1 up to week 48 | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment, and who maintained diaries. | falls | MEDIAN |
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.
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GET https://conductscience.org/api/trials/v1/NCT00977665/outcomes