Trial · NCT01646255
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. A negative mean indicates a reduction of the time off during the conduct of the study |
| Secondary | Percentage of Responders From Baseline to the End of the Doubleblind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | A Responder is defined as a subject with an ≥ 30 % decrease in absolute time spent 'off' |
| Secondary | Percent Change in Absolute Time Spent "Off" From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. Absolute time "off" is defined as the mean number of hours marked "off" during a 24-hour period from all valid daily diary cards. |
| Secondary | Percent Change in Relative Time Spent "Off" From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. Relative time spent "off" will be calculated in two stages. Each valid daily diary will have an associated relative time "off" calculated as relative time "off" for day = 100\*\[total absolute time "off" for day/ absolute time awake for day\]. Relative time spent "off" is then calculated by averaging the daily relative time "off" for the valid days of that visit. |
| Secondary | Change in Absolute Time Spent "on" From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'. Absolute time "on" is defined as the mean number of hours marked "on" during a 24-hour period from all valid daily diary cards. |
| Secondary | Change in Relative Time Spent "on" From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was "off" when taking his/her L-dopa, he/she recorded the exact time their status changed to "on". Relative time spent "on" will be calculated in two stages. Each valid daily diary will have an associated relative time "on" calculated as relative time "on" for day = 100\*\[total absolute time "on" for day/ absolute time awake for day\]. Relative time spent "on" is then calculated by averaging the daily relative time "on" for the valid days of that visit. |
| Secondary | Percent Change in Absolute Time Spent "on" From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'. Note for percent change calculations: when absolute time at Baseline was 0 hours, the absolute Baseline value was assumed to be 1 minute for calculation purposes. |
| Secondary | Percent Change in Relative Time Spent "on" From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was "off" when taking his/her L-dopa, he/she recorded the exact time their status changed to "on". Note for percent change calculations: when relative time at Baseline was 0%, the relative Baseline value was assumed to be 0.1 for calculation purposes. Relative time spent "on" will be calculated in two stages. Each valid daily diary will have an associated relative time "on" calculated as relative time "on" for day = 100\*\[total absolute time "on" for day/ absolute time awake for day\]. Relative time spent "on" is then calculated by averaging the daily relative time "on" for the valid days of that visit. |
| Secondary | Change in the Number of "Off" Periods From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. |
| Secondary | Change in Status of the Subject (on) After Wake-up With Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'. The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the "on with troublesome dyskinesia" state is presented below. |
| Secondary | Change in Status of the Subject (on) After Wake-up Without Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'. The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the "on without troublesome dyskinesia" state is presented below. |
| Secondary | Change in Status of the Subject (Off) After Wake-up From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the "off" state is presented below. |
| Secondary | Change in Unified Parkinson's Disease Rating Scale (UPDRS Part III Motor Examination) During "on" Periods From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | The UPDRS Part III (motor subscale) assessment consists of 27 questions, measured on a 5-Point scale (0 to 4). The sum score is calculated as sum of these 27 individual questions. This score ranges from 0 to 108, higher scores denote greater disability. A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'. |
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
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GET https://conductscience.org/api/trials/v1/NCT01646255/registered