Trial · NCT00977665
Clinical Trial to Assess Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients With Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)
NCT00977665, Phase 2, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2015-02-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Trial to Assess Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients With Multiple System Atrophy of the Parkinsonian Subtype (MSA-P). Trials, record NCT00977665. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00977665
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial to Assess Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients With Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)
- NCT number
- NCT00977665
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 174 participants, actual
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Conditions
- Multiple System Atrophy
- Interventions
- rasagiline mesylate, placebo
- First posted
- 2009-09-16
- Last updated
- 2015-02-26
- Other registries' IDs
- eudract:2009-014644-11
- Results first posted
- 2015-02-26
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | This outcome represents the sum of 2 UMSARS sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement. In the case that 6 items or more (out of 26) were missing at a certain visit, the UMSARS score for that visit was assigned a missing value. |
| Secondary | Clinical Global Impression Improvement (CGI-I) at Week 48/Termination Visit | Week 48 | Outcome measures the investigator's clinical impression of the participants' improvement at Week 48 as compared to Week 12. CGI scale range from 1-7, with 1=very much improved, 4= no change, and 7=very much worse. In order to maintain the overall (hypotheses about primary and key secondary endpoints) type I error at the 0.05 level an hierarchy will be employed as follows: If the primary endpoint will be found to be significant at a significance level of 0.05 then the first key secondary endpoint will be tested, if this endpoint will be found to be significant in a significance level of 0.05 then the second key secondary endpoint will be tested and so on. The 'key' secondary endpoints are outcomes 2-6. |
| Secondary | Change From Baseline to Week 24 in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score | Day 0 (baseline), Week 24 | The UMSARS is composed of 2 sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement. In the case that 6 items or more (out of 26) were missing at a certain visit, the UMSARS score for that visit was assigned a missing value. |
| 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 | UMSARS' Question #7 concerns the participant's ability to walk, rated on a scale of 0=normal to 4=cannot walk at all even with assistance. This endpoint counts participants rated a 3 or worse. Rating 3 = Severely impaired; assistance and/or walking aid needed occasionally. |
| Secondary | Mean Score of the Composite Autonomic Symptom Scale Select (COMPASS_Select Change) at Week 48/Termination Visit | 48 weeks | COMPASS\_Select change is comprised of 5 of the 11 domains in the COMPASS scale: Orthostatic Intolerance, Bladder Disorder, Sweating, Vasomotor, and Sleep Disorder COMPASS\_Select change has a range of -150 to 150, with -150 indicating symptoms are much better and 150 indicating symptoms are much worse. |
| 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 | The Multiple System Atrophy Quality of Life questionnaire (MSA-QoL) is a self-reported questionnaire focusing on MSA-specific symptoms and has a scale ranging from 0 - 160, with 0= 'no problem' and 160= "extreme problem". |
| 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 | The UMSARS is composed of 2 sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. The rate of progression of atrophy is represented by the slope of change from baseline scores for visits between Weeks 12 and 48. |
| 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 | UMSARS Part I is an historical review and scores symptoms of neurological and autonomic dysfunction with 12 items rated on a scale of 0 (normal) to 4 (extreme dysfunction). The full scale for Part 1 is therefore 0 (normal) to 48 (extreme dysfunction). Part II is a motor examination and has 14 items also rated on a scale of 0 to 4 for a full scale of 0 (normal) to 56 (extreme dysfunction). Part IV is a global disability scale with rates the extent of disease from 1 (normal) to 5 (severe disease). |
| Secondary | Change From Baseline to Week 12 in Total UMSARS Score for Symptomatic Effect | Day 0 (baseline), Week 12 | This outcome represents the sum of 2 UMSARS sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement. |
| Secondary | Estimates for Time to Change in Anti-Parkinsonian or Anti-Orthostatis Hypotension Medications | Day 0 (baseline) to Week 48 or termination visit | Change in anti-parkinsonian or anti-orthostatic hypotension medication is defined by at least one of the following events: 1. An addition of a new anti-parkinsonian or anti-orthostatic hypotension medication during study. 2. Dose modification of anti-parkinsonian or anti-orthostatic hypotension concomitant medications reflecting disease progression. The event of interest, determined on a by patient basis, therefore, is the earliest event of the two events defined above. Otherwise, patient is right censored according to his/her study termination date. Since less than 25% of participants had an event, median estimatation for time to change in medications is not possible. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 48/Termination Visit in the Total Unified Multiple System Atrophy Rating Scale (UMSARS Part I and II) | Rasagiline Mesylate | 7.2 | Standard Error 1.186 | units on a scale | |
| Change From Baseline to Week 48/Termination Visit in the Total Unified Multiple System Atrophy Rating Scale (UMSARS Part I and II) | Placebo | 7.8 | Standard Error 1.091 | units on a scale | |
| Clinical Global Impression Improvement (CGI-I) at Week 48/Termination Visit | Rasagiline Mesylate | 4.9 | Standard Error 0.152 | units on a scale | |
| Clinical Global Impression Improvement (CGI-I) at Week 48/Termination Visit | Placebo | 4.8 | Standard Error 0.139 | units on a scale | |
| Change From Baseline to Week 24 in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score | Rasagiline Mesylate | 3.8 | Standard Error 0.811 | units on a scale | |
| Change From Baseline to Week 24 in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score | Placebo | 3.0 | Standard Error 0.760 | units on a scale | |
| Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #7 Regarding Ambulation | Rasagiline Mesylate | 46.4 | percentage of participants | ||
| Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #7 Regarding Ambulation | Placebo | 52.2 | percentage of participants | ||
| Mean Score of the Composite Autonomic Symptom Scale Select (COMPASS_Select Change) at Week 48/Termination Visit | Rasagiline Mesylate | 34.1 | Standard Error 4.342 | units on a scale | |
| Mean Score of the Composite Autonomic Symptom Scale Select (COMPASS_Select Change) at Week 48/Termination Visit | Placebo | 42.7 | Standard Error 4.025 | units on a scale |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rasagiline Mesylate | 84 | |
| Overall Study | STARTED | Placebo | 90 | |
| Overall Study | COMPLETED | Rasagiline Mesylate | 63 | |
| Overall Study | COMPLETED | Placebo | 75 | |
| Overall Study | NOT COMPLETED | Rasagiline Mesylate | 21 | |
| Overall Study | NOT COMPLETED | Placebo | 15 |
Source ClinicalTrials.gov
Adverse events168
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 | CONSTIPATION | Gastrointestinal disorders | Placebo | 5 | 90 | 6 |
| other | CONSTIPATION | Gastrointestinal disorders | Rasagiline Mesylate | 5 | 84 | 5 |
| other | OEDEMA PERIPHERAL | General disorders | Placebo | 6 | 90 | 6 |
| other | OEDEMA PERIPHERAL | General disorders | Rasagiline Mesylate | 9 | 84 | 9 |
| other | NASOPHARYNGITIS | Infections and infestations | Placebo | 6 | 90 | 6 |
| other | NASOPHARYNGITIS | Infections and infestations | Rasagiline Mesylate | 4 | 84 | 4 |
| other | URINARY TRACT INFECTION | Infections and infestations | Placebo | 12 | 90 | 22 |
| other | URINARY TRACT INFECTION | Infections and infestations | Rasagiline Mesylate | 6 | 84 | 14 |
| other | FALL | Injury, poisoning and procedural complications | Placebo | 9 | 90 | 12 |
| other | FALL | Injury, poisoning and procedural complications | Rasagiline Mesylate | 5 | 84 | 6 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Rasagiline Mesylate | ||
| Total, other adverse events | Placebo | 45 | 90 |
| Total, other adverse events | Rasagiline Mesylate | 41 | 84 |
| Total, serious adverse events | Placebo | 23 | 90 |
| Total, serious adverse events | Rasagiline Mesylate | 29 | 84 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25498732 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Rasagiline Mesylate 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/NCT00977665
GET https://conductscience.org/api/trials/v1/NCT00977665/results?page=2