Trial · NCT01929317
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 31 of 31
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Change From Baseline in Actual Hours of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct | Baseline, Weeks, 2, 4, 6, 8 and 12 | "On" state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Change from Baseline in awake time spent "On"(actual hours) is calculated as awake time spent "On" (hours) at the indicated visit minus awake time spent "On" (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. |
| Secondary | Change From Baseline in Actual Hours of Awake Time Spent "On"Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct | Baseline, Weeks, 2, 4, 6, 8 and 12 | "On" state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Change from Baseline in awake time spent "On" without troublesome dyskinesias (actual hours) is calculated as \[awake time spent "On" minus awake time spent "On" with troublesome dyskinesias\] (hours) at visit minus \[awake time spent "On" minus awake time spent "On" with troublesome dyskinesias\] (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. |
| Secondary | Number of Participants With an Improvement (Responder) in the Clinical Global Impression (CGI) Global Improvement Scale at Week 12 | Week 12 | The CGI global improvement scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Scores on the scale range from 1 to 7 (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse). Participants with a CGI global improvement score of \<=2 (representing much improved or very much improved) were considered to be moderate improvement (responder). The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data. |
| Secondary | Number of Participants Remaining in the Study | From the start of the study medication (Week 0) until Week 52 | |
| Secondary | Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase. | Baseline (Week 13), Weeks 17, 21, 25, 37, 49, 52 | The Japanese UPDRS assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Number of participants achieving a 30% or greater and 20% or greater reduction from Baseline in UPDRS total part III score at Weeks 17, 21, 25, 37, 49 and 52,are presented using OC data. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The OC (observed Case) dataset was defined as the dataset consisting of observed data without any missing data imputation. |
| Secondary | Change From Baseline in the Actual Hours of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase | Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52 | "Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Change from Baseline was calculated by subtracting the Baseline value (actual hours of awake time spent "off") from the week 17, 21, 25, 37, 49 and 52 value (proportion of awake time spent "off"). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline.The analyses for long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data |
| Secondary | Change From Baseline in the Percentage of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase | Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52 | "Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Percentage of awake time spent "off" is defined as sum of two days off time (hours) divided by sum of two days awake time (hours) and multiplied by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent "off") from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent "off"). Baseline is defined as the value at Week 13, If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data. |
| Secondary | Change From Baseline in Actual Hours of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase | Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52 | "On" state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Change from Baseline in awake time spent "On"(actual hours) is calculated as awake time spent "On" (hours) at the week 17, 21, 25, 37, 49 and 52 value minus awake time spent "On" (hours) at Baseline. Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. The OC (observed Case) dataset was defined as the dataset consisting of observed data without any missing data imputation. |
| Secondary | Change From Baseline in Actual Hours of Awake Time Spent "On" Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase | Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52 | "On" state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their "on " periods and asleep in diary cards every day. Change from Baseline in awake time spent "On" without troublesome dyskinesias (actual hours) is calculated as \[awake time spent "On" minus awake time spent "On" with troublesome dyskinesias\] (hours) at visit minus \[awake time spent "On" minus awake time spent "On" with troublesome dyskinesias\] (hours) at Baseline. Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data |
| Secondary | Change From Baseline in Percentage of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase | Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52 | "On" state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their "on " periods and asleep in diary cards every day. Percentage of awake time spent "on" is defined as sum of two days on time (hours) divided by sum of two days awake time (hours) and multiplified by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent "on") from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent "on"). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing the first observed value post week 13 was used as a Baseline.The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data. |
| Secondary | Change From Baseline in Percentage of Awake Time Spent "On" Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase | Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52 | "On" state is defined as the state at which PD symptoms are well controlled by the drug. Par. were asked to record the duration of their "on " periods and asleep in diary cards every day. Percentage of awake time spent "On" without troublesome dyskinesias is defined as sum of two days on time without troublesome dyskinesias \["On" time minus "On" time with troublesome dyskinesias\] (hours) divided by sum of two days awake time (hours) and multiplified by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent "On" without troublesome dyskinesias) from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent "On" without troublesome dyskinesias). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing the first observed value post week 13 was used as a Baseline.The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data. |
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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