Trial · NCT01154166
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Total Awake Time Spent Off at Week 24 Using Last Observation Carried Forward (LOCF) | Baseline and Week 24 (Visit 13) | Intent-to-treat (ITT) Population: all randomized participants who received at least one dose of study medication and for whom at least one post-baseline efficacy assessment was available. In the LOCF dataset, the last available on-therapy observation for a participant is used to estimate missing data points. | hours | MEAN |
| SECONDARY | Mean Change From Baseline (BL) in the Unified Parkinson Disease Rating Scale (UPDRS) Total Motor Score at Week 24 Using LOCF | Baseline and Week 24 (Visit 13) | ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method. | scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in the Percentage of Awake Time Spent Off (ATSO) at Week 24 Using LOCF | Baseline and Week 24 | ITT Population. Data were collected using the LOCF method. | Percentage of time | MEAN |
| SECONDARY | Mean Change From Baseline in Total Awake Time Spent on at Week 24 Using LOCF | Baseline and Week 24 | ITT Population. Data were collected using the LOCF method. | hours | MEAN |
| SECONDARY | Mean Change From Baseline in Total Awake Time on Without Troublesome Dyskinesias (TD) at Week 24 Using LOCF | Baseline and Week 24 | ITT Population. Data were collected using the LOCF method. | hours | MEAN |
| SECONDARY | Mean Change From Baseline in the UPDRS Activities of Daily Living (ADL) Score at Week 24 Using LOCF | Baseline and Week 24 | ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method. | scores on a scale | MEAN |
| SECONDARY | Number of Responders Based on the Clinical Global Impression (CGI) Global Improvement Scale Using LOCF | Week 24 | ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method. | participants | NUMBER |
| SECONDARY | Number of Participants Requiring Reinstatement of L-dopa Following a Dose Reduction Using LOCF | Week 24 | ITT Population. Only those participants who had their dose of L-dopa reduced were included in this analysis. Data were collected using the LOCF method. | participants | NUMBER |
| SECONDARY | Number of Responders to Study Treatment Using LOCF | Baseline to Week 24 | ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method. | participants | NUMBER |
| SECONDARY | Mean Change From Baseline in the Depression Scores on the Hamilton Depression Rating Scale (HAMD-17) Using LOCF | Baseline and Week 24 | ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method. | scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline (BL) in the Parkinson's Disease Sleep Scale (PDSS) Total Score Using LOCF | Baseline and Week 24 | ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method. | scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in the Parkinson's Disease Quality of Life Scores (PDQ39) Using LOCF | Baseline and Week 24 | ITT Population. Only those participants contributing data at the indicated time points for the indicated domain were analyzed. Data were collected using the LOCF method. | scores on a scale | MEAN |
| SECONDARY | Time to Reinstatement of L-dopa Following a Reduction in Dose Using LOCF | Baseline to Week 24 | ITT Population. Only those participants who had their dose of L-dopa reduced were included in this analysis. Data were collected using the LOCF method. | days | 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.
For software
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GET https://conductscience.org/api/trials/v1/NCT01154166/outcomes