ropinirole and Parkinson Disease

ropinirole has been researched along with Parkinson Disease in 260 studies

Parkinson Disease: A progressive, degenerative neurologic disease characterized by a TREMOR that is maximal at rest, retropulsion (i.e. a tendency to fall backwards), rigidity, stooped posture, slowness of voluntary movements, and a masklike facial expression. Pathologic features include loss of melanin containing neurons in the substantia nigra and other pigmented nuclei of the brainstem. LEWY BODIES are present in the substantia nigra and locus coeruleus but may also be found in a related condition (LEWY BODY DISEASE, DIFFUSE) characterized by dementia in combination with varying degrees of parkinsonism. (Adams et al., Principles of Neurology, 6th ed, p1059, pp1067-75)

Research

Studies (260)

Authors

Clinical Trials (22)

Trial Overview

Trial Outcomes

Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at Week 12 in the CR High-dose Group

The Japanese Unified Parkinson's Disease Rating Scale (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. Baseline is defined as the value evaluated at Week 0. Mean change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline. The analyses for the Dose Increase Effect Verification Phase was performed using the last observation carried forward (LOCF) data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase. (NCT01929317)
Timeframe: Baseline and Week 12

Number of Participants Remaining in the Study

(NCT01929317)
Timeframe: From the start of the study medication (Week 0) until Week 52

Number of Participants With an Improvement (Responder) in the Clinical Global Impression (CGI) Global Improvement Scale at 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. (NCT01929317)
Timeframe: Week 12

"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"

"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." (NCT01929317)
Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

"Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct"

"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." (NCT01929317)
Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

"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"

"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" (NCT01929317)
Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

"Change From Baseline in Actual Hours of Awake Time Spent OnWithout Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct"

"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." (NCT01929317)
Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

"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"

"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." (NCT01929317)
Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

"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"

"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." (NCT01929317)
Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

"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"

"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" (NCT01929317)
Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

"Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct"

"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 in awake time spent Off(actual hours) is calculated as awake time spent Off (hours) at the indicated visit minus awake time spent Off (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." (NCT01929317)
Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

"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"

"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." (NCT01929317)
Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

"Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct"

"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 the post Baseline value (percentage of awake time spent off). 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." (NCT01929317)
Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase

The Japanese UPDRS assesses the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the 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 the planned visit. (NCT01929317)
Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase

The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms.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 analyses performed using the OC data. In the OC data, no imputation was carried for any missing data. Full Analysis Set 2 (FAS2) Population comprised of all participants in the FAS1 and shifted to Long-term Phase, excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product. (NCT01929317)
Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase

"The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluated activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the 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. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations." (NCT01929317)
Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase

"The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value at Week 13. If the value at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations." (NCT01929317)
Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase

"The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for No and 1 for Yes. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the 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." (NCT01929317)
Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase

"The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for No and 1 for Yes. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms.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 analyses performed using the OC data. In the OC data, no imputation was carried for any missing data." (NCT01929317)
Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits

The Japanese Unified Parkinson's Disease Rating Scale (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. Baseline is defined as the value evaluated at Week 0. Mean change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline. The analyses for the Dose Increase Effect Verification Phase was performed using the last observation carried forward (LOCF) data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase. (NCT01929317)
Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase

The Japanese UPDRS assesses the status of PD participants objectively. Part 3 evaluates motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. 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 analyses performed using the OC data. In the OC data, no imputation was carried for any missing data. (NCT01929317)
Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49, 52

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.

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. (NCT01929317)
Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49, 52

Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase

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 2, 4, 6, 8, and 12 are presented using LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase. (NCT01929317)
Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase

The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated 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. (NCT01929317)
Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase

The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. 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 analyses performed using the OC data. In the OC data, no imputation was carried for any missing data. (NCT01929317)
Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase

"The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. 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. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations." (NCT01929317)
Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase

"The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value at Week 13. If the value at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations." (NCT01929317)
Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase

The Japanese UPDRS assessed the status of PD participants objectively. Part 3 evaluated motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated 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. (NCT01929317)
Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase

The Japanese UPDRS assessed the status of PD participants objectively. Part 3 evaluated motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. 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 analyses performed using the OC data. In the OC data, no imputation was carried for any missing data. (NCT01929317)
Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase

"The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for No and 1 for Yes. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated 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." (NCT01929317)
Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase

"The Japanese UPDRS assesses the status of PD participants objectively. Part 4 evaluates complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for No and 1 for Yes. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. 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 analyses performed using the OC data. In the OC data, no imputation was carried for any missing data." (NCT01929317)
Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

Adverse Events

Patients who have adverse events (NCT00986245)
Timeframe: After 8 weeks in each arm or at last visit for early completion

Compliance

Compliances after 8 weeks in each arm or at last visit for early completion. Compliance was calcuated by the percentage of used medication. (NCT00986245)
Timeframe: 8 weeks for each arm or at last visit

Early Morning Off Symptoms

"Sleep questionnaire 3 for early morning off symptoms Visual analogue scale: 0~10 Higher values represent worse early morning off symptoms." (NCT00986245)
Timeframe: 8 weeks for each arm or at last visit

Epworth Sleep Scale

"Epworth sleep scale after 8 weeks in each arm or at last visit for early completion.~Range: 0~24 Higher values represent worse daytime-sleepiness." (NCT00986245)
Timeframe: 8 weeks in each arm or at last visit for early completion

Hoehn and Yahr Stage

Hoehn and Yahr(HY) stage for parkinsonism after 8 weeks in each arm or at last visit for early completion Range: 0~5 Higher values represent more severe parkinsonism (NCT00986245)
Timeframe: 8 weeks for each arm or at last visit

Nocturnal Off-symptoms

"Sleep questionnaire 2 for Nocturnal off-symptoms Visual analogue scale: 0~10 Higher values represent worse nocturnal off-symptoms." (NCT00986245)
Timeframe: 8 weeks for each arm or at last visit

Overall Quality of Sleep

"Sleep questionnaire 1 for Overall quality of sleep Visual analogue scale: 0~10 Higher values represent worse overall sleep quality." (NCT00986245)
Timeframe: 8 weeks for each arm or at last visit

Patient Preference

Patient preference between once-daily and twice-daily regimen (NCT00986245)
Timeframe: After 16 weeks or at last visit for early completion

Patients Who Have Global Impression for Improvement

Patients who have global impression for improvement for each dosing. (NCT00986245)
Timeframe: After 8 weeks in each arm or at last visit for early completion

Patients Who Have Global Impression for Improvement to Duration of Dyskinesia

Patients who have global impression for improvement to duration of dyskinesia compared (NCT00986245)
Timeframe: After 8 weeks in each arm or at last visit for early completion

Patients Who Have Global Impression for Improvement to Duration of Motor Fluctuation

Patients who have global impression for improvement to duration of motor fluctuation (NCT00986245)
Timeframe: After 8 weeks in each arm or at last visit for early completion

Patients Who Have Global Impression for Improvement to Severity of Dyskinesia

Patients who have Global Impression for Improvement to Severity of Dyskinesia compared (NCT00986245)
Timeframe: After 8 weeks in each arm or at last visit for early completion

Patients Who Have Global Impression for Improvement to Severity of Motor Fluctuation

Patients who have global impression for improvement to severity of motor fluctuation compared (NCT00986245)
Timeframe: After 8 weeks in each arm or at last visit for early completion

Unified Parkinson's Disease Rating Scale, Part 3

"Unified Parkinson's disease rating scale (UPDRS) motor scale after 8 weeks in each arm or at last visit for early completion.~UPDRS part 3 is motor scale for parkinson's disease. Range: 0~108 Higher values represent more severe motor symptoms of parkinsonism." (NCT00986245)
Timeframe: 8 weeks for each arm or at last visit

Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)

AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. SAEs, defined as AEs that are fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication. (NCT00632736)
Timeframe: 13 February 2004 through 31 March 2010

Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26

"The patient preference question assessed the participant's preference for either dosing regimen of study drug, once a day versus three times a day. Participants were asked to respond to the following question to assess preference: Please indicate whether you preferred taking your Parkinson's tablets 3 times a day or once a day. Wk, Week." (NCT00632736)
Timeframe: Week 4 and Week 26

Mean Change From Baseline in the Gambling Symptom Assessment Scale (G-SAS) Score at Week 24

The G-SAS is a reliable and valid self-reported measure of gambling symptoms. It is comprised of twelve questions aimed at evaluating gambling symptoms; each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48, where 0=least severe and 48=most severe. Change from Baseline is calculated as the value at Week 24 minus the Baseline value. (NCT01536574)
Timeframe: Baseline and Week 24

Mean Gambling Symptom Assessment Scale (G-SAS) Score at Week 24

The G-SAS is a reliable and valid self-reported measure of gambling symptoms. It is comprised of twelve questions aimed at evaluating gambling symptoms; each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48, where 0=least severe and 48=most severe. (NCT01536574)
Timeframe: Week 24

Number of Participants With an Adverse Event During the Follow-up Phase

AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition. (NCT01536574)
Timeframe: 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)

Number of Participants With the Indicated Adverse Events During the Follow-up Phase

An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase. (NCT01536574)
Timeframe: 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)

Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase

An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The Investigator determined if an AE/SAE was related to investigational product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase. (NCT01536574)
Timeframe: 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)

Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase

An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The Investigator determined if an AE/SAE was related to investigational product. The On-Treatment Phase is comprised of the Open-label Treatment Phase and the Down-titration Phase. (NCT01536574)
Timeframe: From the start of treatment (Baseline) up to Week 25

Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase)

AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition. (NCT01536574)
Timeframe: From the start of treatment (Baseline) up to Week 25

Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit

"The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows:~0 = Side effects not assessable~1 = No side effects~2 = Side effects do not significantly interfere with subject's functioning~3 = Side effects significantly interfere with the subject's functioning~4 = Side effects outweigh therapeutic efficacy." (NCT01711866)
Timeframe: Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit

Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit

"The PGIC is a 7-point categorical rating scale in which the subject rates the changes in functioning over time as follows:~1 = Very much improved~2 = Much improved~3 = Minimally improved~4 = No change~5 = Minimally worse~6 = Much worse~7 = Very much worse." (NCT01711866)
Timeframe: Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit

"Change From Baseline to the End of the Treatment Period in Absolute Time Spent Off"

"Absolute time spent off is measured in hours per day. A negative value in Change from Baseline to Week 8 indicates that the time spent off decreased from Baseline and therefore indicates an improvement from Baseline.~Only subjects with time spent off at Baseline (subset of the Full Analysis Set (FAS)) are included in the analysis of this outcome measure." (NCT01723904)
Timeframe: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)

"Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Average of on and Off State) Total Score"

"UPDRS Part II measures 'Activities in Daily Living'. The total score ranges from 0 (Best score possible) to 52 (Worst score possible).~UPDRS Part II total score (average of on and off state) is the average of UPDRS Part II total score (on state) and Part II total score (off state).~A negative value in Change from Baseline to Week 8 indicates an improvement in activities in daily living from Baseline." (NCT01723904)
Timeframe: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)

"Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (on State) Total Score"

"The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the 27 sub-items in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total scores therefore ranges from 0 to 108.~A negative value in Change from Baseline to Week 8 indicates an improvement in motor functions from Baseline." (NCT01723904)
Timeframe: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)

"Change From Baseline to the End of the Treatment Period in Time Spent on Without Troublesome Dyskinesia"

"Absolute time spent on without troublesome dyskinesia is measured in hours per day. A positive value in Change from Baseline to Week 8 indicates that the time spent on without troublesome dyskinesia increased from Baseline and therefore indicates an improvement from Baseline." (NCT01723904)
Timeframe: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)

Change From Baseline to the End of Treatment Period in Parkinson's Disease Sleep Scale 2 (PDSS-2) Total Score

"The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep disturbance and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sum score of all 15 questions.~A negative value in Change from Baseline to Week 8 indicates an improvement from Baseline." (NCT01723904)
Timeframe: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)

Change From Baseline to the End of Treatment Period in the Pittsburgh Sleep Quality Index (PSQI) Global Score

"The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire with 18 questions to assess sleep quality. The 18 questions are distributed to 7 elements with each element ranging from 0-3. The global score is the sum score of all 7 elements and ranges from 0-21 with higher values indicating worse sleep quality.~A negative value in Change from Baseline to Week 8 indicates an improvement in sleep quality from Baseline." (NCT01723904)
Timeframe: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)

Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period

"The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows: 0 = Side effects not assessable~= No side effects~= Side effects do not significantly interfere with subject's functioning~= Side effects significantly interfere with the subject's functioning~= Side effects outweigh therapeutic efficacy." (NCT01723904)
Timeframe: Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)

Number of Participants With the Indicated Number of Adverse Events (AEs)

AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. Serious Adverse Events (SAEs), defined as AEs that are either fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication. (NCT00650104)
Timeframe: Every study visit from baseline to market availability (Month 78)

Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)

The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study. CGI-I is a global improvement scale that scores the clinician's view of the participant's global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse). 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse. (NCT00650104)
Timeframe: Week 2, Month 12, Month 78

Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)

The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study. CGI-I is a global improvement scale that scores the clinician's view of the participant's global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse). 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse. (NCT00650104)
Timeframe: Week 2, Month 12, Month 78

Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)

The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study. CGI-I is a global improvement scale that scores the clinician's view of the participant's global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse). 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse. (NCT00650104)
Timeframe: Week 2, Month 12, Month 78

Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)

The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment. (NCT00650104)
Timeframe: Screening; Week 4; Months 3, 9, 15, 21, 27, 33, 39, 45, 51, 57, 63, 69, 75, and 78

Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (ITT Population)

Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study. The Motor Exam has 17 items, some of which are assessed in both the left and right extremities. Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe). The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment). (NCT00650104)
Timeframe: Screening and Month 78

Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Maintained Responder Population)

Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study. The Motor Exam has 17 items, some of which are assessed in both the left and right extremities. Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe). The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment). (NCT00650104)
Timeframe: Screening and Month 78

Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Reponder Population)

Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study. The Motor Exam has 17 items, some of which are assessed in both the left and right extremities. Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe). The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment). (NCT00650104)
Timeframe: Screening and Month 78

Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population)

The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment. (NCT00650104)
Timeframe: Screening; Months 3, 9, 15, 27, and 78

Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population)

The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment. (NCT00650104)
Timeframe: Screening; Months 3, 9, 15, 27, and 78

Change in Albumin

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Alkaline Phosphatase

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Blood Urea Nitrogen

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Calcium

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Chloride

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Clinical Global Impression (CGI) Item 1 Score From Baseline to End of Treatment

"The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 1 measures 'Severity of Parkinson's Disease'. Range: 1 (Normal, not ill at all) to 7 (Among the most extremely ill patients) Change = 28 day value minus baseline value." (NCT00593606)
Timeframe: Baseline, 28 days

Change in Creatinine

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Diastolic Blood Pressure (Standing, After 1 Minute)

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Diastolic Blood Pressure (Standing, After 3 Minutes)

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Diastolic Blood Pressure (Supine, After 1 Minute)

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Diastolic Blood Pressure (Supine, After 5 Minutes)

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Epworth Sleepiness Scale (ESS) Sum Score From Baseline to End of Treatment

The ESS is a self-administered questionnaire in which the subject rates the probability of his/her dozing during 8 situations that are differently conductive to sleep Range: 0 (Best score possible) to 24 (Worst score possible) Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Gamma-Glutamyltransferase

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Glucose

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Glutamic Pyruvic Transaminase

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Heart Rate

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Hematocrit

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Hemoglobin

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Inorganic Phosphate

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Parkinson's Disease Non-Motor Symptom Assessment Scale (PDNMS) Total Sum Score From Baseline to End of Treatment

The PDNMS is a rating by the clinician to assess the severity and frequency of non-motor symptoms in Parkinson's disease patients Range: 0 (Best score possible) to 384 (Worst score possible) Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Parkinson's Disease Sleep Scale (PDSS) Sum Score From Baseline to End of Treatment

"The PDSS is a scale to assess sleep and nocturnal disability in Parkinson's disease.~Range: 0 (Best score possible) to 60 (Worst score possible) Change = 28 day value minus baseline value." (NCT00593606)
Timeframe: Baseline, 28 days

Change in Percentage of Basophilic Granulocytes in White Blood Cell Count

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Percentage of Eosinophilic Granulocytes in White Blood Cell Count

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Percentage of Lymphocytes in White Blood Cell Count

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Percentage of Monocytes in White Blood Cell Count

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Platelet Count

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Potassium

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in PR Interval

"The PR interval is defined as the period that extends from the onset of atrial depolarization (beginning of the P wave) until the onset of ventricular depolarization (beginning of the QRS complex).~Change = 28 day value minus baseline value." (NCT00593606)
Timeframe: Baseline, 28 days

Change in Pulse Rate (Standing, After 1 Minute)

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Pulse Rate (Standing, After 3 Minutes)

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Pulse Rate (Supine, After 1 Minute)

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Pulse Rate (Supine, After 5 Minutes)

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in QRS Duration

"The QRS duration represents the time it takes for ventricular depolarization to occur.~Change = 28 day value minus baseline value." (NCT00593606)
Timeframe: Baseline, 28 days

Change in QT Interval

"The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization.~Change = 28 day value minus baseline value." (NCT00593606)
Timeframe: Baseline, 28 days

Change in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB)

"The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization.~Change = 28 day value minus baseline value." (NCT00593606)
Timeframe: Baseline, 28 days

Change in Red Blood Cell Count

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Serum Glutamic Oxaloacetic Transaminase

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Short-form Parkinson's Disease Questionnaire (PDQ-8) Single Index Score From Baseline to End of Treatment

"The PDQ-8 is a self-administered 8-item questionnaire that assesses issues associated with Parkinson's disease.~Range: 0 (good health) to 100 (poor health) Change = 28 day value minus baseline value." (NCT00593606)
Timeframe: Baseline, 28 days

Change in Sodium

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Systolic Blood Pressure (Standing, After 1 Minute)

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Systolic Blood Pressure (Standing, After 3 Minutes)

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Systolic Blood Pressure (Supine, After 1 Minute)

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Systolic Blood Pressure (Supine, After 5 Minutes)

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 Days

Change in Total Bilirubin

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Total Protein

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score From Baseline to End of Treatment

The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part I measures 'Mentation, Behavior and Mood'. Range: 0 (Best score possible) to 16 (Worst score possible) Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score From Baseline to End of Treatment

The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part II measures 'Activities in Daily Living'. Range: 0 (Best score possible) to 52 (Worst score possible) Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment

The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part III measures 'Motor Examination'. Range: 0 (Best score possible) to 56 (Worst score possible) Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score From Baseline to End of Treatment

The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part IV measures 'Complications of Therapy'. Range: 0 (Best score possible) to 23 (Worst score possible) Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in Uric Acid

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Change in White Blood Cell Count

Change = 28 day value minus baseline value. (NCT00593606)
Timeframe: Baseline, 28 days

Clinical Global Impression (CGI) Item 2 Score

"The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 2 measures 'Global Improvement'. Range 1 (Very much improved) to 7 (Very much worse)" (NCT00593606)
Timeframe: 28 days

Completion of Trial From Baseline to End of Treatment

(NCT00593606)
Timeframe: Baseline, 28 days

Completion of Trial on the Original Treatment Assignment From Baseline to End of Treatment

(NCT00593606)
Timeframe: Baseline, 28 days

Dose Reduction Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period

(NCT00593606)
Timeframe: Baseline, 56 days

Dose Reduction During the 5 Half-life Overlap Period Due to Adverse Events (AEs)

(NCT00593606)
Timeframe: Baseline, 2 days

Drop-out Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period

(NCT00593606)
Timeframe: Baseline, 56 days

Drop-out During the 5 Half-life Overlap Period Due to Adverse Events (AEs)

(NCT00593606)
Timeframe: Baseline, 2 days

Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Coordination/Balance'

(NCT00593606)
Timeframe: 28 days

Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Cranial Nerve Function'

(NCT00593606)
Timeframe: 28 days

Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Deep Tendon Reflexes'

(NCT00593606)
Timeframe: 28 days

Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Gait'

(NCT00593606)
Timeframe: 28 days

Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Involuntary Movements'

(NCT00593606)
Timeframe: 28 days

Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Mental Status'

(NCT00593606)
Timeframe: 28 days

Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Muscle Strength'

(NCT00593606)
Timeframe: 28 days

Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Other'

(NCT00593606)
Timeframe: 28 days

Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Plantar Reflex'

(NCT00593606)
Timeframe: 28 days

Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Sensory Perception'

(NCT00593606)
Timeframe: 28 days

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Cardiovascular'

(NCT00593606)
Timeframe: 28 days

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Dermatological'

(NCT00593606)
Timeframe: 28 days

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Ears, Eyes, Nose, Mouth, Throat'

(NCT00593606)
Timeframe: 28 days

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hematological/Lymphatic Nodes'

(NCT00593606)
Timeframe: 28 days

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hepato-/Gastrointestinal'

(NCT00593606)
Timeframe: 28 days

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Metabolic/Endocrine'

(NCT00593606)
Timeframe: 28 days

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Musculoskeletal'

(NCT00593606)
Timeframe: 28 days

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Other'

(NCT00593606)
Timeframe: 28 days

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Peripheral Vascular'

(NCT00593606)
Timeframe: 28 days

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Psychiatric'

(NCT00593606)
Timeframe: 28 days

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Pulmonary'

(NCT00593606)
Timeframe: 28 days

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Renal/Genitourological'

(NCT00593606)
Timeframe: 28 days

Patient Global Impression (PGI) Item 1 Score

"The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 1 measures 'Global Improvement'. Range: 1 (Very much improved) to 7 (Very much worse)" (NCT00593606)
Timeframe: 28 days

Clinical Global Impression (CGI) Item 3.1

"The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 3.1 measures 'Therapeutic Effect'. Range: 1 (Marked - Vast improvement. Complete or nearly complete remission of all symptoms.) to 4 (Unchanged or worse)" (NCT00593606)
Timeframe: 28 days

Clinical Global Impression (CGI) Item 3.2

"The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 3.2 measures 'Therapeutic Side Effects'. Range: 1 (None) to 4 (Outweigh the therapeutic effect)" (NCT00593606)
Timeframe: 28 days

Patient Global Impression (PGI) Item 2

"The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 2 measures 'Therapeutic Effect'. Range: 1 (Marked - Vast improvement. Complete or nearly complete remission of all symptoms) to 4 (Unchanged or worse)" (NCT00593606)
Timeframe: 28 days

Patient Global Impression (PGI) Item 3

"The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 3 measures 'Side Effects'. Range: 1 (I have no side effects) to 4 (They outweigh the therapeutic effect of the trial medication)" (NCT00593606)
Timeframe: 28 days

Patient Treatment Preference Scale Question 1

Have you used pharmaceutical treatments for your Parkinson's disease before the study? (NCT00593606)
Timeframe: 28 days

Patient Treatment Preference Scale Question 2

Why did you decide to enter this study? (NCT00593606)
Timeframe: 28 days

Patient Treatment Preference Scale Question 3

In comparing the patch and previous oral treatments for Parkinson's disease, how satisfied have you been with oral medication / patch? (NCT00593606)
Timeframe: 28 days

Patient Treatment Preference Scale Question 4

I would prefer using a patch over taking a pill or capsule for treatment of my Parkinson's disease. (NCT00593606)
Timeframe: 28 days

Patient Treatment Preference Scale Question 5

I would prefer applying one 40cm**2 patch over applying two 20cm**2 patches for treatment of my Parkinson's disease. (NCT00593606)
Timeframe: 28 days

Patient Treatment Preference Scale Question 6

What aspects do you like the most about the patch? (NCT00593606)
Timeframe: 28 days

Patient Treatment Preference Scale Question 7

What aspects do you like the least about the patch? Check all that apply. (NCT00593606)
Timeframe: 28 days

Common Adverse Events: Back Pain

Musculoskeletal and Connective Tissue Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Constipation

Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Depression

Psychiatric Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Diarrhoea

Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Dizziness

Nervous system disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Dyspepsia

Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Fatigue

General Disorders and Administration Site Conditions. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Headache

Nervous System disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Hypotension

Vascular Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Insomnia

Psychiatric Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Nasopharyngitis

Infections and infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Nausea

Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Oedema Peripheral

General disorders and administration site conditions. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Sinusitis

Infections and Infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Somnolence

Nervous System Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Upper Respiratory Tract Infection

Infections and Infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Activities of Daily Living(ADL) Subscale of the Unified Parkinson's Disease Rating Scale

The outcome is defined as change in ADL subscale of the Unified Parkinson's Disease Rating Scale(UPDRS Part II) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part II: Activities of Daily Living in the week prior to the designated visit, consisting of 13 questions answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total Part II score represents the sum of these 13 questions. A greater increase in score indicates a greater increase in disability. A total of 52 points are possible. 52 represents the worst (total) disability), 0--no disability (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Beck Depression Inventory II (BDI-II)

The Beck Depression Inventory (BDI) is a validated self-reported 21-item depression scale that was tested and validated as a reliable instrument for screening for depression in PD. The outcome is defined as change in BDI-II between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Total BDI score represents the sum of these 21-items. A higher change in score indicates a greater increase in disability. Total score of 0-13 is considered minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Mental Subscales of the Unified Parkinson's Disease Rating Scale

The outcome is defined as change in Mental subscale of Unified Parkinson's Disease Rating Scale(UPDRS Part I) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part I: Mentation, behavior and mood, consisting of 4 questions answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total score represents the sum of these 4 questions. A greater increase in score indicates a greater increase in disability. A total of 16 points are possible. 16 represents the worst (total) disability), 0--no disability. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Modified Hoehn & Yahr Scale

The Modified Hoehn & Yahr Scale is an 8-level Parkinson's disease staging instrument. The outcome is defined as change in Modified Hoehn & Yahr Scale between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. A greater increase in stage indicates a greater increase in disability. Stage ranges from 0-5 (also including 1.5 and 2.5) with 0 indicating no disability and 5 indicating maximum disability. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Modified Schwab & England Independence Scale

The Schwab & England scale is an investigator and subject assessment of the subject's level of independence at all scheduled study visits. The subject will be scored on a percentage scale reflective of his/her ability to perform acts of daily living in relation to what he/she did before Parkinson's disease appeared. The outcome is defined as change in Schwab & England Independence Scale between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Higher decrease in score indicates higher disability. Score ranges from 100% (complete independence) to 0% (total disability). (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Montreal Cognitive Assessment

The Montreal Cognitive Assessment(MoCA) is a brief 30-point screening instrument that was developed and validated to identify subjects with mild cognitive impairment. The outcome is defined as change in MoCA between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Total MoCA score represents the sum of these 30-points, with a lower score indicating greater cognitive impairment. 30 is the maximum score, with a score of 26 or higher considered normal and below 26 indicative of Mild Cognitive Impairment. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Motor Subscale of the Unified Parkinson's Disease Rating Scale

The outcome is defined as change in Motor subscale of the Unified Parkinson's Disease Rating Scale(UPDRS Part III) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part III: motor abilities at the time of the visit, consisting of 27 items (including 13 general questions and 14 sub-questions) each answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total Part III score represents the sum of these 27 items. A total of 108 points are possible. 108 represents the worst (total) disability), 0--no disability. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Parkinson Disease Quality of Life Questionnaire-39(PDQ-39)

The PD Quality of Life Scale(PDQ-39) asks the subject to evaluate how Parkinson disease has affected their health and overall quality of life at that point in time. The total quality of life scale includes subscales relating to social role, self-image/sexuality, sleep, outlook, physical function and urinary function. The outcome is defined as change in PDQ-39 between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. It is scored on a scale of zero to 100, with lower scores indicating better health and higher scores more severe disability. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Unified Parkinson's Disease Rating Scale (UPDRS)

Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline visit and month 12 or the time to require dopaminergic therapy (last visit before subject goes on dopaminergic therapy), whichever occurs first. The UPDRS score has 4 components. Part I assesses mentation; Part II assesses activities of daily living; Part III assesses motor abilities; Part IV assesses complications of therapy. A total of 44 items are included in Parts I-III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Part IV contains 11 items, 4 of these items are scored 0-4 in the same manner, and 7 are scored 0-1, with 0 indicating the absence of impairment and 1 indicating the presence of impairment. Total UPDRS score represents the sum of these items in Parts I-IV. A total of 199 points are possible. 199 represents the worst (total) disability), 0--no disability. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Tolerability of the Three Dosages(5mg, 10mg and 20mg) of Isradipine CR.

Tolerability will be judged by the proportion of subjects enrolled in a dosage group able to complete the 12 month study or to the time of initiation of dopaminergic therapy on their original assigned dosage. Tolerability of each active arm will be compared to placebo group. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Vital Signs: Change in Diastolic Standing

(NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Vital Signs: Change in Diastolic Supine

(NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Vital Signs: Change in Pulse Standing

(NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Vital Signs: Change in Pulse Supine

(NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Vital Signs: Change in Systolic Standing

(NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Vital Signs: Change in Systolic Supine

(NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy of DHA - Change in Blood ng/dL Levels

Therapeutic level monitoring will be accomplished by analyzing blood levels for DHA. (NCT01563913)
Timeframe: baseline and 1.5 years

Efficacy of DHA - Number of Participants With An Abnormal Safety Lab (CBC)

This study is seeking to determine the safety/efficacy of DHA in Parkinson's disease patients. The safety/efficacy of DHA will be determined using periodic safety lab information. Safety labs for complete blood count (CBC) were performed at each inpatient visit, reviewed by the PI, and marked as normal or abnormal. (NCT01563913)
Timeframe: Year 1

Reviews

62 reviews available for ropinirole and Parkinson Disease