Trial · NCT01602549
Outcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose-normalized Levodopa (L-DOPA) Area Under the Plasma Concentration-time Curve From Zero to 4 Hours AUC(0-4) at Baseline | Baseline | Pharmacodynamic (PD)/Efficacy Population: participants receiving \>=1 dose placebo/GSK962040 50 mg. Only those participants available at the specified time point were analyzed. | Nanograms*hour/milliliter/milligram | GEOMETRIC_MEAN |
| PRIMARY | Dose-normalized L-DOPA AUC(0-4) at Day 1 and Day 8 | Day 1 and Day 8 | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Nanograms*hour/milliliter/milligram | LEAST_SQUARES_MEAN |
| PRIMARY | Dose-normalized L-DOPA Maximum Observed Concentration (Cmax) at Baseline | Baseline | PD/Efficacy Population. Only those participants available at the specified time point were analyzed. | Nanograms/milliliter/milligram | GEOMETRIC_MEAN |
| PRIMARY | Dose-normalized L-DOPA Cmax at Day 1 and Day 8 | Day 1 and Day 8 | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Nanograms/milliliter/milligram | LEAST_SQUARES_MEAN |
| PRIMARY | L-DOPA Time of Occurrence of Cmax (Tmax) at Baseline, Day 1,and Day 8 | Baseline, Day 1, and Day 8 | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Hours | MEDIAN |
| PRIMARY | L-DOPA Terminal Phase Half-life (t1/2) at Baseline, Day 1, and Day 8 | Baseline, Day 1, and Day 8 | |||
| SECONDARY | Gastric Half Emptying Time (GE t1/2) at Baseline (BL), Day 1, and Day 8 | Baseline, Day 1, and Day 8 | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Minutes | MEAN |
| SECONDARY | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Baseline, Day 1, and Day 8 at pre-levodopa dose | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Scores on a scale | MEAN |
| SECONDARY | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Scores at Baseline, Day 1, and Day 8 (Pre-dose; 120, 180, and 240 Minutes Post-dose) | Baseline, Day 1, and Day 8 at pre-dose and 120, 180, and 240 minutes (min) post-dose (PD); Follow-up visit (up to Day 25) | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Scores on a scale | MEAN |
| SECONDARY | Period Mean Amount of Hours Spent ON, ON Without Dyskinesia, ON With Non-troublesome Dyskinesia, ON With Troublesome Dyskinesia, and OFF at Baseline and During the Treatment Period (Days 1-8), Week 1 of Follow-up, and Week 2 of Follow-up | Baseline, Days 1-8, Week 1 of Follow-up (Days 6 and 7 of Follow-up; up to Day 16), and Week 2 of Follow-up (Days 13 and 14 of Follow-up; up to Day 23) | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | hours | MEAN |
| SECONDARY | Number of Times a Participant Could Alternatively Tap Two Counter Keys 30 Centimeters Apart in 1 Minute (Min) at Baseline, Day1, Day 8, and Follow-up | Baseline, Day 1, and Day 8 at pre-dose and 0, 30, 60, 90, 120, 180, and 240 minutes post-dose; Follow-up visit (up to Day 25) | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Finger taps per minute | MEAN |
| SECONDARY | Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Baseline and Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Milligrams | MEAN |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8 | Baseline, Day 1, and Day 8 | All Subjects Population (ASP): all participants who received \>=1 dose of study medication. Participants with available data (n=X, X in category titles) were analyzed. | Millimeters of mercury | MEAN |
| SECONDARY | Change From Baseline in Heart Rate at Day 1 and Day 8 | Baseline, Day 1, and Day 8 | ASP. Participants with available data (n=X, X in category titles) were analyzed. | Beats per minute | MEAN |
| SECONDARY | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 1 and Day 8 | ASP. Participants with available data (n=X, X in category titles) were analyzed. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Albumin (ALB) and Total Protein (TP) at Day 4 and Day 8 | Baseline, Day 4, and Day 8 | ASP. Participants with available data (n=X, X in category titles) were analyzed. | Grams per liter | MEAN |
| SECONDARY | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) at Day 4 and Day 8 | Baseline, Day 4, and Day 8 | ASP. Participants with available data (n=X, X in category titles) were analyzed. | International units per liter | MEAN |
| SECONDARY | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content (CO2)/Bicarbonate (BC), Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN), and Uric Acid (UA) at Day 4 and Day 8 | Baseline, Day 4, and Day 8 | ASP. Participants with available data (n=X, X in category titles) were analyzed. | Millimoles per liter | MEAN |
| SECONDARY | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Baseline, Day 4, and Day 8 | ASP. Participants with available data (n=X, X in category titles) were analyzed. | Giga (10^9) cells per liter | MEAN |
| SECONDARY | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Day 4 and Day 8 | Baseline, Day 4, and Day 8 | ASP. Participants with available data (n=X, X in category titles) were analyzed. | Grams per liter | 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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