Trial · NCT01287221
Study of Rifampicin in Multiple System Atrophy
NCT01287221, Phase 3, Terminated, Phillip Low; results first posted 2014-03-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Rifampicin in Multiple System Atrophy. Trials, record NCT01287221. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01287221
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Rifampicin in Multiple System Atrophy
- NCT number
- NCT01287221
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 100 participants, actual
- Lead sponsor
- Phillip Low
- Conditions
- Multiple System Atrophy
- Interventions
- Rifampicin, placebo
- First posted
- 2011-02-01
- Last updated
- 2014-03-28
- Results first posted
- 2014-03-28
- Limitations and caveats
- The study was terminated early; the Data Safety and Monitoring Board recommended stopping the study after an interim analysis of the primary endpoint revealed that futility criteria were met.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Change From Baseline to 12 Months in the Total Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (Minus Question 11) | baseline, 12 months | UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for Part I could range from 0 (normal) to 48 (extreme dysfunction). Participant-specific rate of change in points per month was estimated using slope estimate from least square regression where for each participant, their UMSARS I scores were plotted over time measured in months. |
| Secondary | Change From Baseline to 12 Months in UMSARS Part I Score (Minus Question 11) | baseline, 12 months | UMSARS is a scale measuring disease progression that comprises 4 parts, only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for Part I could range from 0 (normal) to 48 (extreme dysfunction). |
| Secondary | Change From Baseline to 12 Months in UMSARS Part II | baseline, 12 months | UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part II has 14 items with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for Part II could range from 0 (normal) to 56 (extreme dysfunction). |
| Secondary | Change From Baseline to 12 Months in Total UMSARS (i.e., UMSARS Part I Minus Question 11 + UMSARS Part II) | baseline, 12 months | UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Part II has 14 items with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for total UMSARS Parts I minus Question 11 + Part II could range from 0 (normal) to 104 (extreme dysfunction). |
| Secondary | Rate of Change From Baseline to 12 Months in Total UMSARS (i.e., UMSARS Part I Minus Question 11 + UMSARS Part II) Using Slope Estimate | baseline, 12 months | UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Part II has 14 items with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for total UMSARS Parts I minus Question 11 + Part II could range from 0 (normal) to 104 (extreme dysfunction). Participant-specific rate of change in points per month was estimated using slope estimate from least square regression where for each participant, their total UMSARS scores were plotted over time measured in months. |
| Secondary | Change From Baseline to 12 Months in the COMPASS-Select Scale | baseline, 12 months | The composite autonomic symptoms score (COMPASS) provides a score of autonomic symptom severity with appropriate weighting. In the COMPASS\_select, symptoms are confined to 6 select domains of symptoms. The version of the COMPASS-Select used (06-09-2009 v1) has 46 questions, with multiple parts, scores ranging from "much worse" to "no such symptoms." Scores could range from 0 (no such symptoms) to 85 (much worse). |
| Secondary | Change in the COMPASS-Select-Change Scale From Baseline to 12 Months | baseline, 12 months | The change in COMPASS is a derivative of COMPASS and evaluates the change in symptoms over time on selected domains of symptoms as a function of natural history or intervention therapy. The focus is on 7 selected domains. The version of the COMPASS-Change -Select Scale used (06-09-2009 Ver. 1) has 16 questions, with multiple parts, scores ranging from "much worse" to "no such symptoms." The score could range from 0 (no such symptoms) to 94 (much worse). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Change From Baseline to 12 Months in the Total Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (Minus Question 11) | baseline, 12 months | Analysis was done using intention to treat principles and no imputations were done for any missing values or slope estimates. All randomized participants who took at least two doses of the study drug were included in the principal efficacy analysis. One subject on the Rifampicin arm did not return after the baseline visit. | units on a scale per month | MEAN |
| SECONDARY | Change From Baseline to 12 Months in UMSARS Part I Score (Minus Question 11) | baseline, 12 months | Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 12 Months in UMSARS Part II | baseline, 12 months | Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 12 Months in Total UMSARS (i.e., UMSARS Part I Minus Question 11 + UMSARS Part II) | baseline, 12 months | Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study. | units on a scale | MEAN |
| SECONDARY | Rate of Change From Baseline to 12 Months in Total UMSARS (i.e., UMSARS Part I Minus Question 11 + UMSARS Part II) Using Slope Estimate | baseline, 12 months | Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study. | units on a scale per month | MEAN |
| SECONDARY | Change From Baseline to 12 Months in the COMPASS-Select Scale | baseline, 12 months | Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study. | units on a scale | MEAN |
| SECONDARY | Change in the COMPASS-Select-Change Scale From Baseline to 12 Months | baseline, 12 months | Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Change From Baseline to 12 Months in the Total Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (Minus Question 11) | Rifampicin | 0.5 | Standard Deviation 0.7 | units on a scale per month | |
| Rate of Change From Baseline to 12 Months in the Total Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (Minus Question 11) | Placebo | 0.5 | Standard Deviation 0.5 | units on a scale per month | |
| Change From Baseline to 12 Months in UMSARS Part I Score (Minus Question 11) | Rifampicin | 6.2 | Standard Deviation 5.6 | units on a scale | |
| Change From Baseline to 12 Months in UMSARS Part I Score (Minus Question 11) | Placebo | 5.6 | Standard Deviation 5.0 | units on a scale | |
| Change From Baseline to 12 Months in UMSARS Part II | Rifampicin | 7.0 | Standard Deviation 6.3 | units on a scale | |
| Change From Baseline to 12 Months in UMSARS Part II | Placebo | 5.4 | Standard Deviation 6.6 | units on a scale | |
| Change From Baseline to 12 Months in Total UMSARS (i.e., UMSARS Part I Minus Question 11 + UMSARS Part II) | Rifampicin | 12.9 | Standard Deviation 10.6 | units on a scale | |
| Change From Baseline to 12 Months in Total UMSARS (i.e., UMSARS Part I Minus Question 11 + UMSARS Part II) | Placebo | 10.8 | Standard Deviation 10.7 | units on a scale | |
| Rate of Change From Baseline to 12 Months in Total UMSARS (i.e., UMSARS Part I Minus Question 11 + UMSARS Part II) Using Slope Estimate | Rifampicin | 1.1 | Standard Deviation 1.0 | units on a scale per month | |
| Rate of Change From Baseline to 12 Months in Total UMSARS (i.e., UMSARS Part I Minus Question 11 + UMSARS Part II) Using Slope Estimate | Placebo | 1.2 | Standard Deviation 1.2 | units on a scale per month |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rifampicin | 50 | |
| Overall Study | STARTED | Placebo | 50 | |
| Overall Study | Completed 3 Months Follow-up | Rifampicin | 49 | |
| Overall Study | Completed 3 Months Follow-up | Placebo | 50 | |
| Overall Study | Completed 6 Months Follow-up | Rifampicin | 47 | |
| Overall Study | Completed 6 Months Follow-up | Placebo | 43 | |
| Overall Study | Completed 9 Months Follow-up | Rifampicin | 42 | |
| Overall Study | Completed 9 Months Follow-up | Placebo | 40 | |
| Overall Study | Completed 12 Months Follow-up | Rifampicin | 40 | |
| Overall Study | Completed 12 Months Follow-up | Placebo | 39 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events178
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Speech impairment | General disorders | Rifampicin | 0 | 50 | 0 |
| other | Speech impairment | General disorders | Placebo | 1 | 50 | 1 |
| other | Prolonged QTc Interval | Cardiac disorders | Rifampicin | 0 | 50 | 0 |
| other | Prolonged QTc Interval | Cardiac disorders | Placebo | 1 | 50 | 1 |
| other | Leukocytes | Immune system disorders | Rifampicin | 1 | 50 | 1 |
| other | Leukocytes | Immune system disorders | Placebo | 0 | 50 | 0 |
| other | Nausea | Gastrointestinal disorders | Rifampicin | 6 | 50 | 6 |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 50 | 1 |
| other | Neutrophils/granulocytes | Immune system disorders | Rifampicin | 1 | 50 | 1 |
| other | Neutrophils/granulocytes | Immune system disorders | Placebo | 0 | 50 | 0 |
1 to 10 of 178Source ClinicalTrials.gov
See all 178 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rifampicin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Rifampicin | 31 | 50 |
| Total, other adverse events | Placebo | 26 | 50 |
| Total, serious adverse events | Rifampicin | 3 | 50 |
| Total, serious adverse events | Placebo | 12 | 50 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24507091 | RESULT |
Source PubMed
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U54NS065736 | Autonomic Rare Diseases Clinical Research Consortium | BIAGGIONI, ITALO | VANDERBILT UNIVERSITY MEDICAL CENTER | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2009 to 2018 | NIH RePORTER |
| P01NS044233 | Pathogenesis and Diagnosis of Multiple System Atrophy (P01) | LOW, PHILLIP A | MAYO CLINIC ROCHESTER | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2003 to 2014 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Rifampicin vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01287221
GET https://conductscience.org/api/trials/v1/NCT01287221/events?page=2