Trial · NCT01602549
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-normalized Levodopa (L-DOPA) Area Under the Plasma Concentration-time Curve From Zero to 4 Hours AUC(0-4) at Baseline | Baseline | Dose-normalized L-DOPA AUC(0-4) was derived from L-DOPA plasma concentration-time data. AUC is a measure of levodopa exposure. |
| Primary | Dose-normalized L-DOPA AUC(0-4) at Day 1 and Day 8 | Day 1 and Day 8 | Dose-normalized L-DOPA AUC(0-4) was derived from L-DOPA plasma concentration-time data. The adjusted means and ratios (GSK962040 50 mg: Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa pharmacokinetic (PK) parameter, and Baseline gastric emptying half-time as fixed effects, and participant as a random effect. AUC is a measure of levodopa exposure |
| Primary | Dose-normalized L-DOPA Maximum Observed Concentration (Cmax) at Baseline | Baseline | Dose-normalized L-DOPA Cmax was derived from L-DOPA plasma concentration-time data. |
| Primary | Dose-normalized L-DOPA Cmax at Day 1 and Day 8 | Day 1 and Day 8 | Dose-normalized L-DOPA Cmax was derived from L-DOPA plasma concentration-time data. The adjusted means and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter, and Baseline gastric emptying half-time as fixed effects, and participant as a random effect. |
| Primary | L-DOPA Time of Occurrence of Cmax (Tmax) at Baseline, Day 1,and Day 8 | Baseline, Day 1, and Day 8 | L-DOPA Tmax was derived from L-DOPA plasma concentration-time data. |
| Primary | L-DOPA Terminal Phase Half-life (t1/2) at Baseline, Day 1, and Day 8 | Baseline, Day 1, and Day 8 | L-DOPA t1/2 was derived from L-DOPA plasma concentration-time data. This endpoint was not assessed because there were insufficient L-DOPA data/profiles to calculate this parameter. |
| Secondary | Gastric Half Emptying Time (GE t1/2) at Baseline (BL), Day 1, and Day 8 | Baseline, Day 1, and Day 8 | Gastric half emptying time is the time taken for half the contents of the stomach to empty. Gastric emptying was measured using the 13C-oral breath test, which is a tracer method that utilizes 13C, a non-radioactive isotope. Basal breath samples were obtained after an overnight fast or otherwise after 4 hours of fasting following a light meal. On Day 1 and Day 8, participants were then dosed with GSK962040 and additional breath test samples were taken prior to administration of a 13C-labelled test meal. The test meal was consumed approximately 80 minutes later. After consumption of the test meal, breath samples were collected at pre-specified time points over an approximately 4 hour period following the test meal. For the duration of the breath test, no food or drink were allowed. The 13C breath content was determined by isotope ratio mass spectrometry. GE t1/2 was determined by using the cumulative percentage of the administered dose of 13C excreted in breath over 4 hours. |
| 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 | The MDS-UPDRS is used to assess the status of Parkinson's Disease. It has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination), and Part IV (motor complications). Each part is made up of several questions, with each question given a score ranging from 0 (normal) to 4 (severe). Part I and Part II consist of 13 items each, and have a score ranging between 0 (normal) and 52 (severe). Part III consists of 33 items, and has a score ranging between 0 (normal) and 132 (severe). Part IV consists of 6 items, and has a score ranging between 0 (normal) and 24 (severe). The total score is the summed score of all four parts and ranges between 0 (normal) and 260 (severe). A higher score indicates more severe symptoms. |
| 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) | The MDS-UPDRS is used to assess the status of Parkinson's Disease. It has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination), and Part IV (motor complications). Each part is made up of several questions, with each question given a score ranging from 0 (normal) to 4 (severe). Part I and Part II consist of 13 items each, and have a score ranging between 0 (normal) and 52 (severe). Part III consists of 33 items, and has a score ranging between 0 (normal) and 132 (severe). Part IV consists of 6 items, and has a score ranging between 0 (normal) and 24 (severe). The total score is the summed score of all four parts and ranges between 0 (normal) and 260 (severe). A higher score indicates more severe symptoms. |
| 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) | Participants were provided with the "ON/OFF" diary to capture details of the amount of awake time spent on/off of PD symptoms, and were asked to complete the diary daily. Participants checked the box most appropriate for their dominant motor state in the preceding 30-minute period. The catergories included: "ON" (including "ON without dyskinesia" and "ON with non-troublesome dyskinesia"), "ON" with troublesome dyskinesia (TD), and "OFF." For Baseline, data were collected for 2 days prior to Day 1, and the mean value of the 2 days was used. |
| 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) | Participants were asked to alternatively tap two keys 30 centimeters apart in 1 minute in two trials with the most affected hand or the dominant hand in symmetric disease. The finger tapping was scored manually by the study staff. The finger-tapping assessment was repeated at eight separate time points (pre-dose, 0 min, 30 min, 60 min, 90 min, 120 min, 180 min, and 240 min post-dose) at each visit (Baseline, Day 1, and Day 8). At each time point, the mean of the two assessments was calculated. |
| 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 | Various formulations of L-DOPA were utilized by participants for the treatment of Parkinson's Disease. The total daily L-DOPA equivalent dose was calculated as the sum of all L-DOPA equivalent doses for each L-DOPA-containing drug taken on the same day. |
| 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 | Blood pressure measurements were taken at pre-dose and at 0 min (completion of meal) on Day 1 and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value. |
| Secondary | Change From Baseline in Heart Rate at Day 1 and Day 8 | Baseline, Day 1, and Day 8 | Heart rate measurements were taken at pre-dose and 0 min (completion of meal) on Day 1 and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value. |
| Secondary | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 1 and Day 8 | ECG measurements were taken at pre-dose and 0 min (completion of meal) on Day 1 and Day 8. The Baseline value was the Day 1 pre-dose value. ECG findings were categorized as normal, abnormal - not clinically significant, and abnormal - clinically significant (CS), based on interpretation by the site. |
| Secondary | Change From Baseline in Albumin (ALB) and Total Protein (TP) at Day 4 and Day 8 | Baseline, Day 4, and Day 8 | ALB and TP measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value. |
| 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 | ALP, ALT, AST, and GGT measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value. |
| 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 | Calcium, chloride, CO2/BC, glucose, potassium, sodium, urea/BUN, and UA measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value. |
| 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 | Basophils, eosinophils, lymphocytes, monocytes, total ANC, and PC measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value. |
| Secondary | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Day 4 and Day 8 | Baseline, Day 4, and Day 8 | Hemoglobin and MCHC measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value. |
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/NCT01602549/registered