Trial · NCT01628926
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Unified Parkinson's Disease Rating Score (UPDRS) Part 3 Sum Score | baseline, 16 weeks after dosing | Full analysis set (FAS), last observation carried forward (LOCF) | Scores on a scale | MEAN |
| SECONDARY | UPDRS Part 3 Sum Score | baseline, 8 and 10 weeks after dosing | FAS, LOCF | Scores on a scale | MEAN |
| SECONDARY | UPDRS Part 2 Sum Score | Baseline, 16 weeks after dosing | FAS, LOCF | Scores on a scale | MEAN |
| SECONDARY | Off Time | Baseline, 16 weeks after dosing | FAS subjects with measurable off time data at baseline, LOCF | Hours/day | MEAN |
| SECONDARY | Parkinson's Disease Sleep Scale-2 (PDSS-2) | Baseline, 16 weeks after dosing | FAS, LOCF | Scores on a scale | MEAN |
| SECONDARY | On Time | Baseline, 16 weeks after dosing | FAS, LOCF | Hours/day | MEAN |
| SECONDARY | On Time Without Dyskinesia Disturbing Daily Activities | Baseline, 16 weeks after dosing | FAS, LOCF Evaluation for this outcome measure was not possible, because only 22.6% (37/164), 12.7% (21/165), and 6.0% (5/83) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had dyskinesia disturbing daily activities on either day from baseline until the end of titration/maintenance. | Hours/day | MEAN |
| SECONDARY | On Time With Dyskinesia Disturbing Daily Activities | Baseline, 16 weeks after dosing | FAS, LOCF Evaluation for this outcome measure was not possible, because only 22.6% (37/164), 12.7% (21/165), and 6.0% (5/83) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had dyskinesia disturbing daily activities on either day from baseline until the end of titration/maintenance period. | Hours | MEAN |
| SECONDARY | Effective Rate in UPDRS Part 3 Sum Score | Baseline, 16 weeks after dosing | FAS, LOCF | Percentage of participants | NUMBER |
| SECONDARY | Effective Rate in UPDRS Part 2 Sum Score | Baseline, 16 weeks after dosing | FAS, LOCF | Percentage of participants | NUMBER |
| SECONDARY | Effective Rate in Off Time | Baseline, 16 weeks after dosing | FAS subjects with measurable off time data at baseline, LOCF | Percentage of participants | NUMBER |
| SECONDARY | Clinical Global Impression (CGI) | Baseline, 16 weeks after dosing | FAS, LOCF | Percentage of Participants | NUMBER |
| SECONDARY | Dystonia (at an Early Hour) | Baseline, 16 weeks after dosing | FAS, LOCF Evaluation for this outcome measure was not possible, because 87.1% (142/163), 88.5% (146/165), and 91.4% (74/81) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had no dystonia in the day time at baseline. | Percentage of participants | NUMBER |
| SECONDARY | Dystonia (in the Daytime) | Baseline, 16 weeks after dosing | Appropriate interpretation for this outcome measure was not possible, because 87.1% (142/163), 88.5% (146/165), and 91.4% (74/81) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had no dystonia in the day time at baseline. | Percentage of Participants | NUMBER |
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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