Trial · NCT01929317
Outcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at Week 12 in the CR High-dose Group | Baseline and Week 12 | Full Analysis Set 1 (FAS1) Population: all participants excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product. | Scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits | Baseline, Weeks, 2, 4, 6, 8 and 12 | Full Analysis Set 1 (FAS1) Population: all participants excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product. | Scores on a scale | MEAN |
| SECONDARY | Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase | Baseline, Weeks, 2, 4, 6, 8 and 12 | FAS1 Population | Participants | NUMBER |
| SECONDARY | Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase | Baseline, Weeks, 2, 4, 6, 8 and 12 | FAS1 Population | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase | Baseline, Weeks, 2, 4, 6, 8 and 12 | FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 population. | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase | Baseline, Weeks, 2, 4, 6, 8 and 12 | FAS1 Population | Scores on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase | Baseline, Weeks, 2, 4, 6, 8 and 12 | FAS1 Population. Only those participants available at the specified time points were analyzed. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase | Baseline, Weeks, 2, 4, 6, 8 and 12 | FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 population. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase | Baseline, Weeks, 2, 4, 6, 8 and 12 | FAS1 Population | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase | Baseline, Weeks, 2, 4, 6, 8 and 12 | FAS1 Population. Only those participants available at the specified time points were analyzed. | Percent change | MEAN |
| SECONDARY | Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase | Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52 | FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population. | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase | Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52 | FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population. | Scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase | Baseline (Week 13), Weeks 17, 21, 25, 37, 49, 52 | FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population. | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase | Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52 | FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population. | Scores on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase | Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52 | FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase | Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52 | FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase | Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52 | FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase | Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52 | FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population. | Percent change | MEAN |
| SECONDARY | Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct | Baseline, Weeks, 2, 4, 6, 8 and 12 | FAS1 Population. Only those participants available at the specified time points were analyzed. | hours | MEAN |
| SECONDARY | Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct | Baseline, Weeks, 2, 4, 6, 8 and 12 | FAS1 Population. Only those participants available at the specified time points were analyzed. | percentage of awake time spent off | MEAN |
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.
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