Trial · NCT02687542
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 | Change From Baseline in Daily OFF Time at Week 10 | Week 10; Baseline was defined as the average daily OFF time (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit day 0). | Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary). | Hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daily OFF Time | Weeks 3, 5, 10 and 15; Baseline was defined as the average daily OFF time (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit day 0). | Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary). | Hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daily ON Time With Troublesome Dyskinesia | Weeks 3, 5, 10 and 15; Baseline was defined as the average daily ON time with Troublesome Dyskinesia (using 3 Hauser patient diary Days) prior to Day -1 (study derived day and equalled to nominal visit Day 0). | Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary). | Hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daily ON Time Without Troublesome Dyskinesia | Weeks 3, 5, 10 and 15; Baseline was defined as the average daily ON time without Troublesome Dyskinesia (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit Day 0) | Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary). | Hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III | Weeks 1, 2, 3, 4, 5, 10 and 15; Baseline was defined as the Day -1 (study derived day and equalled to nominal visit Day 0) measurement | Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, IV, and Total Score | Weeks 5, 10 and 15; Baseline was defined as the Day -1 (study derived day and equalled to nominal visit Day 0) measurement | Full Analysis Set included all participants randomized who completed at least 1 postdose efficacy measurement(Hauser home diary). | units on a scale | MEAN |
| SECONDARY | Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | Baseline (Day 0) to Week 17 | Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Vital Sign Results Meeting the Criteria for Categorical Summarization | Baseline (Day 0) to Week 17 | Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Electrocardiogram (ECG) Results Meeting the Criteria for Categorical Summarization | Baseline (Day 0) to Week 17 | Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Suicidal Ideation Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) at Post-baseline Visits | Days 0 (Baseline), 7, 14, 21, 28, 35, 70, 77, 84, 91, 105 and 119 | Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified time points. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Total Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS) | Baseline (Day 0) and Weeks 5, 10 and 15 | Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified time points. | units on a scale | MEAN |
| SECONDARY | Total Physician Withdrawal Checklist (PWC-20) on Days 105 and 119, and Change From Day 105 to Day 119 | Days 105 and 119 | Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified time points. | units on a scale | MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths | Day 1 to follow-up (Week 19 visit) | Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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/NCT02687542/outcomes