Trial · NCT00256204
A Randomized Placebo Controlled Study to Show That Rasagiline May Slow Disease Progression for Parkinson's Disease
NCT00256204, Phase 3, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2011-06-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomized Placebo Controlled Study to Show That Rasagiline May Slow Disease Progression for Parkinson's Disease. Trials, record NCT00256204. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00256204
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Placebo Controlled Study to Show That Rasagiline May Slow Disease Progression for Parkinson's Disease
- NCT number
- NCT00256204
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,174 participants, actual
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Conditions
- Parkinson's Disease
- Interventions
- Rasagiline Mesylate, Rasagiline Mesylate, Placebo
- First posted
- 2005-11-21
- Last updated
- 2012-01-12
- Results first posted
- 2011-06-21
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline | 12w, 24w, 36w, 42w, 48w, 54w, 60w, 66w, 72w | The primary efficacy endpoint was defined as the change in Total UPDRS from Baseline. Subjects were assessed according to the United Parkinson's Disease Rating Scale (UPDRS,(version 3;) Parts I and II are historical data and are designed to rate mentation, behavior and mood; Part III is done as a motor examination at the time of a visit. The UPDRS measures patient status on a scale 0, which is normal or none, to 4, which is severe or the worst scenario. |
| Secondary | Change in Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to Last Observed Value in the Placebo Phase | 36 weeks | Subjects were assessed according to the United Parkinson's Disease Rating Scale UPDRS,(version 3;) Parts I and II are historical data and are designed to rate mentation, behavior and mood; Part III is done as a motor examination at the time of a visit. The UPDRS measures patient status on a scale 0, which is normal or none, to 4, which is severe or the worst scenario. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline | 12w, 24w, 36w, 42w, 48w, 54w, 60w, 66w, 72w | Scores on a scale | MEAN | |
| SECONDARY | Change in Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to Last Observed Value in the Placebo Phase | 36 weeks | Scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline | 1mg Delayed Start | Week 12 | 0.9 | Standard Deviation 4.9 | Scores on a scale |
| Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline | 1mg Early Start | Week 12 | -1.2 | Standard Deviation 5.6 | Scores on a scale |
| Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline | 2mg Early Start | Week 12 | -0.7 | Standard Deviation 4.8 | Scores on a scale |
| Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline | 2mg Delayed Start | Week 12 | 0.7 | Standard Deviation 5.6 | Scores on a scale |
| Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline | 1mg Delayed Start | Week 24 | 3.0 | Standard Deviation 6.5 | Scores on a scale |
| Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline | 1mg Early Start | Week 24 | -1.1 | Standard Deviation 5.6 | Scores on a scale |
| Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline | 2mg Early Start | Week 24 | -0.5 | Standard Deviation 5.6 | Scores on a scale |
| Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline | 2mg Delayed Start | Week 24 | 2.2 | Standard Deviation 6.5 | Scores on a scale |
| Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline | 1mg Delayed Start | Week 36 | 3.7 | Standard Deviation 7.2 | Scores on a scale |
| Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline | 1mg Early Start | Week 36 | 0.6 | Standard Deviation 5.9 | Scores on a scale |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1mg Delayed Start | 298 | |
| Overall Study | STARTED | 1mg Early Start | 288 | |
| Overall Study | STARTED | 2mg Delayed Start | 295 | |
| Overall Study | STARTED | 2mg Early Start | 293 | |
| Overall Study | COMPLETED | 1mg Delayed Start | 231 | |
| Overall Study | COMPLETED | 1mg Early Start | 238 | |
| Overall Study | COMPLETED | 2mg Delayed Start | 241 | |
| Overall Study | COMPLETED | 2mg Early Start | 244 | |
| Overall Study | NOT COMPLETED | 1mg Delayed Start | 67 | |
| Overall Study | NOT COMPLETED | 1mg Early Start | 50 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events357
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 | Back Pain | Musculoskeletal and connective tissue disorders | Placebo Combined Group | 32 | 593 | 34 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | 1mg Active Treatment | 14 | 288 | 14 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | 2mg Active Treatment | 15 | 293 | 15 |
| other | Headache | Nervous system disorders | Placebo Combined Group | 37 | 593 | 39 |
| other | Headache | Nervous system disorders | 1mg Active Treatment | 14 | 288 | 15 |
| other | Headache | Nervous system disorders | 2mg Active Treatment | 15 | 293 | 15 |
| other | Fatigue | General disorders | Placebo Combined Group | 17 | 593 | 18 |
| other | Fatigue | General disorders | 1mg Active Treatment | 17 | 288 | 18 |
| other | Fatigue | General disorders | 2mg Active Treatment | 10 | 293 | 10 |
| serious | Coronary Artery Disease | Cardiac disorders | Placebo Combined Group | 1 | 593 | 1 |
1 to 10 of 357Source ClinicalTrials.gov
See all 357 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Combined Group | ||
| Total, all-cause mortality | 1mg Active Treatment | ||
| Total, all-cause mortality | 2mg Active Treatment | ||
| Total, other adverse events | Placebo Combined Group | 82 | 593 |
| Total, other adverse events | 1mg Active Treatment | 40 | 288 |
| Total, other adverse events | 2mg Active Treatment | 34 | 293 |
| Total, serious adverse events | Placebo Combined Group | 22 | 593 |
| Total, serious adverse events | 1mg Active Treatment | 37 | 288 |
| Total, serious adverse events | 2mg Active Treatment | 44 | 293 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00256204
GET https://conductscience.org/api/trials/v1/NCT00256204/results?page=2