Trial · NCT01191944
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Unified Parkinsons Disease Rating Scale (UPDRS) Parts II+III Score at Week 18 | Baseline and week 18 | Full analysis set (FAS) with last observation carried forward (LOCF). FAS is defined as all randomised patients which received at least one dose of study drug and provided any post baseline efficacy assessment. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Percentage Off-time During Waking Hours at Week 18 | Baseline and week 18 | FAS (LOCF) reduced to patients with advanced Parkinsons Disease (PD). Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary. | Percentage off-time | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Duration of Off-time During Waking Hours at Week 18 | Baseline and week 18 | FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary. | hours | LEAST_SQUARES_MEAN |
| SECONDARY | Responder in Percentage Off-time During Waking Hours at Week 18 | Baseline and week 18 | FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Percentage On-time Without Dyskinesia at Week 18 | Baseline and week 18 | FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary. | Percentage of on-time | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18 | Baseline and week 18 | FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary. | Percentage of on-time | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Percentage On-time Without or With Non-troublesome Dyskinesia at Week 18 | Baseline and week 18 | FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary. | Percentage of on-time | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18 | Baseline and week 18 | FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary. | Percentage of on-time | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Duration of On-time Without Dyskinesia at Week 18 | Baseline and week 18 | FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary. | hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Duration of On-time With Non-troublesome Dyskinesia at Week 18 | Baseline and week 18 | FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary. | hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Duration of On-time Without or With Non-troublesome Dyskinesia at Week 18 | Baseline and week 18 | FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary. | hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Duration of On-time With Troublesome Dyskinesia at Week 18 | Baseline and week 18 | FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary. | hours | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impression of Improvement (CGI-I) Responder at Week 18 | 18 weeks | FAS (LOCF). Only patients with on-treatment CGI-I evaluation were analyzed. | Participants | NUMBER |
| SECONDARY | Patient Global Impressions of Improvement (PGI-I) Responder at Week 18 | 18 weeks | FAS (LOCF) | Participants | NUMBER |
| SECONDARY | Responder in UPDRS Parts II+III Score at Week 18 | Baseline and week 18 | FAS (LOCF) | Participants | NUMBER |
| SECONDARY | Change From Baseline in UPDRS II Score Separately at Week 18 | Baseline and week 18 | FAS (LOCF) | Units on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at 18 Weeks | Baseline and week 18 | Observed cases (OC). Only patients with ESS assessment at baseline and at 18 weeks were analyzed. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in UPDRS III Score Separately at Week 18 | Baseline and week 18 | FAS (LOCF) | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Levodopa (L-Dopa) Introduction During the Study | 18 weeks | FAS. Only patients without concomitant L-Dopa treatment at baseline. | Participants | NUMBER |
| SECONDARY | Levodopa (L-Dopa) Dose Change During the Study | 18 weeks | FAS. Only patients with concomitant L-Dopa treatment at baseline. | mg | 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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01191944/outcomes