Trial · NCT01494532
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline (BL) in Total Awake Time Spent Off at Week 4 of Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | The Intent to Treat(ITT) Population included all randomized par who received at least one dose of study medication, had a BL efficacy assessment for the outcome, and at least one respective Post-BL efficacy assessment. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Hours | LEAST_SQUARES_MEAN |
| SECONDARY | Responder Rate Defined as the Percentage of Participants With a 20% Reduction in Baseline (BL) Off Time at Week-4 of Maintenance Period | Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | percentage of participants | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With a >=1 Hour Reduction in Baseline Off Time at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | percentage of participants | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With a >=2 Hours Reduction in Baseline Off Time at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | percentage of participants | LEAST_SQUARES_MEAN |
| SECONDARY | Responder Rate According to the Clinical Global Impression-global Improvement (CGI-I) Scale at Week 4 of the Maintenance Period | Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Absolute Awake Time Spent on Without Troublesome Dyskinesia (TD) at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Absolute Awake Time Spent on at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline for Total Sleep Time During the Night Time Hours of Sleep at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Hours | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Awake Time Spent Off at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Percentage of off time in hours | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Awake Time Spent on Without TD at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Percentage of on time in hours | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Awake Time Spent on at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Percentage of on time in hours | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Sleep Time During the Night Time Hours of Sleep, at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Percentage of total sleep time in hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Percent Awake Time Spent Off at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Percentage of off time in hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Percent Awake Time Spent on Without TD at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Percentage of on time in hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Percent Awake Time Spent on at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Percentage of on time in hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Percent of a 24-hour Day Spent Off at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Percentage of off time in hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Percent of a 24- Hour Day Spent on Without TD at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Percentage of on time in hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Percent of a 24-hour Day Spent on at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Percentage of on time in hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Total Sleep Time During the Night Time Hours of Sleep as a Percentage of a 24-hour Day, at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Percentage of time in hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Unified Parkinson Disease Rating Scale (UPDRS) Motor Score With Participants in an on State, at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Score on scale | LEAST_SQUARES_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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