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This is a phase III, multicenter, randomized, double-blind, parallel group, placebo-controlled study to compare the efficacy of 6-months therapy of ropinirole Prolonged Release (PR) with that of placebo as adjunctive therapy to L-dopa in Parkinson's disease patients not optimally controlled on L-dopa. This study will be conducted in China. Subjects will have total 14 visits over the 26 week duration of the study.
Following screening, eligible subjects will receive study medication during the fourteen day placebo run-in period which they will be instructed to take in addition to their background L-dopa. If subjects are still eligible at the end of the placebo run-in period they will be randomized (1:1) to receive once daily doses of ropinirole PR or identical appearing placebo tablets. Dosing will start at 2 mg ropinirole PR, or placebo equivalent. During the 24 week treatment phase, the subjects dose will be adjusted according to the recommended schedule to achieve symptomatic control. All subjects must be titrated to a minimum dose of 6 mg/day. If sufficient symptomatic control is not achieved or maintained at a dose of 6mg/day of ropinirole PR, the daily dose should be increased by 2mg at weekly or longer intervals up to a dose of 8mg/day.If sufficient symptomatic control is still not achieved or maintained at a dose of 8mg/day of ropinirole PR, the daily dose should be increased by 4mg at two weekly or longer intervals. Further dose titration should not be conducted within the final 8 weeks of the treatment phase. The maximum recommended daily dose is 24mg.
The planned reduction in L-dopa dose will begin once subjects are titrated to Dose Level 4 or Dose Level 5 of study medication. For each increase in study medication, there will be a corresponding decrease in L-dopa. If loss of symptom control occurs with the reduction in the background L-dopa dose, the dose of study medication should be increased to the next higher dose level with no adjustment in the dose of L-dopa. If loss of symptom control persists, subjects should be titrated up an additional dose level. Subjects who do not experience an improvement in symptoms following upward titration by 2 dose levels of study medication, should be "rescued" with L-dopa.
Subjects will be dispensed down-titration medication at the study completion/early withdrawal visit if the patient did not enter extension study and should be scheduled to return for a follow up visit 4 to 14 days after the last dose of study medication. The extension study aim to evaluate the safety profile of ReQuip PR during long-term treatment in subjects with advanced parkinson's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReQuip PR | Experimental | Ropinirole PR tablets of 2.0 mg, 4.0mg and 8.0 mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReQuip PR | Drug | If subjects are still eligible at the end of the placebo run-in period they will be randomized (1:1) to receive once daily doses of ropinirole PR or identical appearing placebo tablets. Dosing will start at 2 mg ropinirole PR, or placebo equivalent. During the 24 week treatment phase, the subjects dose will be adjusted according to the recommended schedule to achieve symptomatic control. All subjects must be titrated to a minimum dose of 6 mg/day. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Total Awake Time Spent "Off" at Week 24 Using Last Observation Carried Forward (LOCF) | The "off" state is defined as the state in which Parkinson's Disease (PD) symptoms (lack of mobility, tremor, or rigidity) are not adequately controlled by the drug. Participants were asked to record the duration of their "off " periods in 24-hour diary cards prior to each visit on two days of each relevant week. The total number of awake hours spent "off" per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. Change from Baseline is calculated as the value at Week 24 minus the Baseline value. | Baseline and Week 24 (Visit 13) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline (BL) in the Unified Parkinson Disease Rating Scale (UPDRS) Total Motor Score at Week 24 Using LOCF | The UPDRS, a clinician-based rating scale, assesses 6 features of PD impairment: (1) mentation, behavior, and mood; (2) activities of daily living; (3) motor examination; (4) complications of therapy; (5) modified Hoehn and Yahr stage; (6) Schwab and England activities of daily living scale. Assessments were conducted when participants had benefit in regard to mobility, tremor, and rigidity. The total motor score (sum of motor examination) ranges from 0 to 108: 0=normal/no symptoms; 108=worst possible case. Change from BL was calculated as the value at Week 24 minus the value at BL. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Guangzhou | Guangdong | 510120 | China | ||
| GSK Investigational Site |
After the 14-day Run-in Phase with placebo, eligible participants (par.) entered the 24-week Treatment Phase (TP) and were randomized 1:1 to ropinirole PR or placebo. After the TP, all par. were down-titrated for 7 days. Those who did not enter the extension study returned for a follow-up visit 4-14 days after the last dose of medication.
A total of 347 participants were randomized; however, 2 participants were not dosed after randomization and were excluded from the Safety Population. An additional participant had no post-baseline assessment available and was thus excluded from the Intent-to-Treat Population. Thus, only 344 of the 347 randomized participants "started" the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be "rescued" with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Placebo | Drug | Placebo |
|
| Baseline and Week 24 (Visit 13) |
| Mean Change From Baseline in the Percentage of Awake Time Spent "Off" (ATSO) at Week 24 Using LOCF | The "off" state is defined as the state in which PD symptoms (lack of mobility, tremor, or rigidity) are not adequately controlled by the drug. Participants were asked to record the duration of their "off" periods in 24-hour diary cards prior to each visit on the same 2 days of each relevant week. The total number of awake hours spent "off" per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. The percentage of ATSO=ATSO divided by (ATSO + awake time spent "on") * 100. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. | Baseline and Week 24 |
| Mean Change From Baseline in Total Awake Time Spent "on" at Week 24 Using LOCF | The "on" state is defined as the state in which the PD symptoms (lack of mobility, tremor, or rigidity) are adequately controlled by the drug. Participants were asked to record the duration of their "on" periods in 24-hour diary cards prior to each visit on the same two days of each relevant week. The total number of awake hours spent "on" per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. Change from Baseline is calculated as the value at Week 24 minus the Baseline value. | Baseline and Week 24 |
| Mean Change From Baseline in Total Awake Time "on" Without Troublesome Dyskinesias (TD) at Week 24 Using LOCF | Dyskinesias are involuntary twisting, turning movements caused by medication during "on" time in PD. TD is defined as those movements that interfere with function and cause meaningful discomfort. Participants were asked to record the number of awake hours spent "on" without TD in 24-hour diary cards prior to each visit on the same two days of each relevant week. The total number of awake hours spent"on"without TD per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. Change from Baseline is calculated as the value at Week 24 minus the Baseline value. | Baseline and Week 24 |
| Mean Change From Baseline in the UPDRS Activities of Daily Living (ADL) Score at Week 24 Using LOCF | The UPDRS assesses six features of PD impairment, including Activities of Daily Living (ADL). The total ADL score ranges from 0 to 52, where 0= normal/no symptoms and 52= worst possible case. Change from Baseline is calculated as the value at Week 24 minus the Baseline value. | Baseline and Week 24 |
| Number of Responders Based on the Clinical Global Impression (CGI) Global Improvement Scale Using LOCF | 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 responders. | Week 24 |
| Number of Participants Requiring Reinstatement of L-dopa Following a Dose Reduction Using LOCF | In the event of unacceptable side effects relative to Baseline (e.g., dyskinesias, dystonias [neurological movement disorder]) the dosage of L-dopa was reduced. If there was reduction in the side effects and there was loss of symptom control, the dose of study medication was again increased (reinstated) at subsequent visits. If symptoms could still not be controlled, then L-dopa was reinstated; however, the dose could not exceed the baseline dose. | Week 24 |
| Number of Responders to Study Treatment Using LOCF | The "off" state is defined as the state in which PD symptoms (lack of mobility, tremor, or rigidity) are not adequately controlled by the drug. Responders are defined as participants who had at least a 20% reduction from Baseline in awake time spent "off" and at least a 20% reduction from Baseline in the L-dopa dose. | Baseline to Week 24 |
| Mean Change From Baseline in the Depression Scores on the Hamilton Depression Rating Scale (HAMD-17) Using LOCF | The HAMD-17 is a 17-item scale that is completed by the investigator. Each item was evaluated and scored using either a 5-point scale (e.g., absent, mild, moderate, severe, very severe) or a 3-point scale (e.g., absent, mild, marked). The total HAMD-17 score (sum of the scores of all 17 items) may range from 0 (least severe) to 52 (most severe). Change from Baseline is calculated as the value at Week 24 minus the Baseline value. | Baseline and Week 24 |
| Mean Change From Baseline (BL) in the Parkinson's Disease Sleep Scale (PDSS) Total Score Using LOCF | The PDSS uses a series of 15 questions to assess sleep disturbance associated with PD. Participants completed the assessments based on their experiences in the past week by marking a cross on each 10 centimeter (cm) scale (labelled from worst to best state). Responses were quantified by measuring the distance along each line where the cross was placed. The scores for each item ranged from 0 (symptom severe and always experienced) to 10 (symptom free). The maximum cumulative score for the PDSS was thus 150 (free of all symptoms). Change from BL=value at Week 24 minus the BL value. | Baseline and Week 24 |
| Mean Change From Baseline in the Parkinson's Disease Quality of Life Scores (PDQ39) Using LOCF | The PDQ39 is a 39 item self-administered questionnaire. The questionnaire covers eight domains of health that are reported as adversely affected by patients with PD. Participants were asked to rate responses on a scale from 0 to 4 ("never" to "always"). The overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem). Change from Baseline is calculated as the value at Week 24 minus the Baseline value. | Baseline and Week 24 |
| Time to Reinstatement of L-dopa Following a Reduction in Dose Using LOCF | The mean number of days after which the dose of L-dopa was readministered after the reduction in dose was recorded. | Baseline to Week 24 |
| Wuhan |
| Hubei |
| 430022 |
| China |
| GSK Investigational Site | Suzhou | Jiangsu | 215004 | China |
| GSK Investigational Site | Xi'an | Shaanxi | 710061 | China |
| GSK Investigational Site | Chengdu | Sichuan | 610041 | China |
| GSK Investigational Site | Chengdu | Sichuan | 610072 | China |
| GSK Investigational Site | Kunming | Yunnan | 650032 | China |
| GSK Investigational Site | Kunming | Yunnan | 650101 | China |
| GSK Investigational Site | Hangzhou | Zhejiang | 310009 | China |
| GSK Investigational Site | Beijing | 100034 | China |
| GSK Investigational Site | Beijing | 100050 | China |
| GSK Investigational Site | Beijing | 100053 | China |
| GSK Investigational Site | Beijing | 100730 | China |
| GSK Investigational Site | Beijing | 100853 | China |
| GSK Investigational Site | Shanghai | 200025 | China |
| GSK Investigational Site | Shanghai | 200032 | China |
| GSK Investigational Site | Shanghai | 200040 | China |
| GSK Investigational Site | Tianjin | 300052 | China |
| FG001 | Ropinirole PR | Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be "rescued" with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication. |
| BG001 | Ropinirole PR | Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline data were collected in members of the Intent-to-Treat (ITT) Population, comprised of all randomized participants who received at least one dose of study medication and for whom at least one post-baseline efficacy assessment was available. | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Baseline data were collected in members of the Intent-to-Treat (ITT) Population, comprised of all randomized participants who received at least one dose of study medication and for whom at least one post-baseline efficacy assessment was available. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Baseline data were collected in members of the Intent-to-Treat (ITT) Population, comprised of all randomized participants who received at least one dose of study medication and for whom at least one post-baseline efficacy assessment was available. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in Total Awake Time Spent "Off" at Week 24 Using Last Observation Carried Forward (LOCF) | The "off" state is defined as the state in which Parkinson's Disease (PD) symptoms (lack of mobility, tremor, or rigidity) are not adequately controlled by the drug. Participants were asked to record the duration of their "off " periods in 24-hour diary cards prior to each visit on two days of each relevant week. The total number of awake hours spent "off" per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. Change from Baseline is calculated as the value at Week 24 minus the Baseline value. | Intent-to-treat (ITT) Population: all randomized participants who received at least one dose of study medication and for whom at least one post-baseline efficacy assessment was available. In the LOCF dataset, the last available on-therapy observation for a participant is used to estimate missing data points. | Posted | Mean | Standard Deviation | hours | Baseline and Week 24 (Visit 13) |
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| Secondary | Mean Change From Baseline (BL) in the Unified Parkinson Disease Rating Scale (UPDRS) Total Motor Score at Week 24 Using LOCF | The UPDRS, a clinician-based rating scale, assesses 6 features of PD impairment: (1) mentation, behavior, and mood; (2) activities of daily living; (3) motor examination; (4) complications of therapy; (5) modified Hoehn and Yahr stage; (6) Schwab and England activities of daily living scale. Assessments were conducted when participants had benefit in regard to mobility, tremor, and rigidity. The total motor score (sum of motor examination) ranges from 0 to 108: 0=normal/no symptoms; 108=worst possible case. Change from BL was calculated as the value at Week 24 minus the value at BL. | ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Week 24 (Visit 13) |
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| Secondary | Mean Change From Baseline in the Percentage of Awake Time Spent "Off" (ATSO) at Week 24 Using LOCF | The "off" state is defined as the state in which PD symptoms (lack of mobility, tremor, or rigidity) are not adequately controlled by the drug. Participants were asked to record the duration of their "off" periods in 24-hour diary cards prior to each visit on the same 2 days of each relevant week. The total number of awake hours spent "off" per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. The percentage of ATSO=ATSO divided by (ATSO + awake time spent "on") * 100. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. | ITT Population. Data were collected using the LOCF method. | Posted | Mean | Standard Deviation | Percentage of time | Baseline and Week 24 |
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| Secondary | Mean Change From Baseline in Total Awake Time Spent "on" at Week 24 Using LOCF | The "on" state is defined as the state in which the PD symptoms (lack of mobility, tremor, or rigidity) are adequately controlled by the drug. Participants were asked to record the duration of their "on" periods in 24-hour diary cards prior to each visit on the same two days of each relevant week. The total number of awake hours spent "on" per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. Change from Baseline is calculated as the value at Week 24 minus the Baseline value. | ITT Population. Data were collected using the LOCF method. | Posted | Mean | Standard Deviation | hours | Baseline and Week 24 |
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| Secondary | Mean Change From Baseline in Total Awake Time "on" Without Troublesome Dyskinesias (TD) at Week 24 Using LOCF | Dyskinesias are involuntary twisting, turning movements caused by medication during "on" time in PD. TD is defined as those movements that interfere with function and cause meaningful discomfort. Participants were asked to record the number of awake hours spent "on" without TD in 24-hour diary cards prior to each visit on the same two days of each relevant week. The total number of awake hours spent"on"without TD per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. Change from Baseline is calculated as the value at Week 24 minus the Baseline value. | ITT Population. Data were collected using the LOCF method. | Posted | Mean | Standard Deviation | hours | Baseline and Week 24 |
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| Secondary | Mean Change From Baseline in the UPDRS Activities of Daily Living (ADL) Score at Week 24 Using LOCF | The UPDRS assesses six features of PD impairment, including Activities of Daily Living (ADL). The total ADL score ranges from 0 to 52, where 0= normal/no symptoms and 52= worst possible case. Change from Baseline is calculated as the value at Week 24 minus the Baseline value. | ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Week 24 |
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| Secondary | Number of Responders Based on the Clinical Global Impression (CGI) Global Improvement Scale Using LOCF | 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 responders. | ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method. | Posted | Number | participants | Week 24 |
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| Secondary | Number of Participants Requiring Reinstatement of L-dopa Following a Dose Reduction Using LOCF | In the event of unacceptable side effects relative to Baseline (e.g., dyskinesias, dystonias [neurological movement disorder]) the dosage of L-dopa was reduced. If there was reduction in the side effects and there was loss of symptom control, the dose of study medication was again increased (reinstated) at subsequent visits. If symptoms could still not be controlled, then L-dopa was reinstated; however, the dose could not exceed the baseline dose. | ITT Population. Only those participants who had their dose of L-dopa reduced were included in this analysis. Data were collected using the LOCF method. | Posted | Number | participants | Week 24 |
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| Secondary | Number of Responders to Study Treatment Using LOCF | The "off" state is defined as the state in which PD symptoms (lack of mobility, tremor, or rigidity) are not adequately controlled by the drug. Responders are defined as participants who had at least a 20% reduction from Baseline in awake time spent "off" and at least a 20% reduction from Baseline in the L-dopa dose. | ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method. | Posted | Number | participants | Baseline to Week 24 |
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| Secondary | Mean Change From Baseline in the Depression Scores on the Hamilton Depression Rating Scale (HAMD-17) Using LOCF | The HAMD-17 is a 17-item scale that is completed by the investigator. Each item was evaluated and scored using either a 5-point scale (e.g., absent, mild, moderate, severe, very severe) or a 3-point scale (e.g., absent, mild, marked). The total HAMD-17 score (sum of the scores of all 17 items) may range from 0 (least severe) to 52 (most severe). Change from Baseline is calculated as the value at Week 24 minus the Baseline value. | ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Week 24 |
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| Secondary | Mean Change From Baseline (BL) in the Parkinson's Disease Sleep Scale (PDSS) Total Score Using LOCF | The PDSS uses a series of 15 questions to assess sleep disturbance associated with PD. Participants completed the assessments based on their experiences in the past week by marking a cross on each 10 centimeter (cm) scale (labelled from worst to best state). Responses were quantified by measuring the distance along each line where the cross was placed. The scores for each item ranged from 0 (symptom severe and always experienced) to 10 (symptom free). The maximum cumulative score for the PDSS was thus 150 (free of all symptoms). Change from BL=value at Week 24 minus the BL value. | ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Week 24 |
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| Secondary | Mean Change From Baseline in the Parkinson's Disease Quality of Life Scores (PDQ39) Using LOCF | The PDQ39 is a 39 item self-administered questionnaire. The questionnaire covers eight domains of health that are reported as adversely affected by patients with PD. Participants were asked to rate responses on a scale from 0 to 4 ("never" to "always"). The overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem). Change from Baseline is calculated as the value at Week 24 minus the Baseline value. | ITT Population. Only those participants contributing data at the indicated time points for the indicated domain were analyzed. Data were collected using the LOCF method. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Week 24 |
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| Secondary | Time to Reinstatement of L-dopa Following a Reduction in Dose Using LOCF | The mean number of days after which the dose of L-dopa was readministered after the reduction in dose was recorded. | ITT Population. Only those participants who had their dose of L-dopa reduced were included in this analysis. Data were collected using the LOCF method. | Posted | Mean | Standard Deviation | days | Baseline to Week 24 |
|
Adverse event (AE) and serious adverse event (SAE) data are presented for the On-treatment Phase (Week 1 to Week 24) plus the 7-day Down-titration Period.
SAEs and non-serious AEs were collected in the Safety Population, consisting of all participants who received at least one dose of randomized study medication (placebo or active drug). This does not include placebo given during the Placebo Run-in Period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be "rescued" with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication. | 8 | 170 | 105 | 170 | ||
| EG001 | Ropinirole PR | Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR. | 9 | 175 | 129 | 175 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
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| Lung infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Neurogenic bladder | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Akinesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyskinesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Akinesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dyspraxia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebral artery embolism | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dystonia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Head titubation | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Narcolepsy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Parkinsonian gait | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Vascular headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Change of bowel habit | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Discomfort | General disorders | MedDRA | Systematic Assessment |
| |
| Face edema | General disorders | MedDRA | Systematic Assessment |
| |
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Illusion | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Dependence | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Hypersexuality | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Angiopathy | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Orthostatic hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Impetigo | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Subcutaneous nodule | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Livedo reticularis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac discomfort | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Neutrophil count abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA | Systematic Assessment |
| |
| Conjunctival hyperemia | Eye disorders | MedDRA | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA | Systematic Assessment |
| |
| Exophthalmos | Eye disorders | MedDRA | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA | Systematic Assessment |
| |
| Night blindness | Eye disorders | MedDRA | Systematic Assessment |
| |
| Oculogyric crisis | Eye disorders | MedDRA | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Neurogenic bladder | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Choking sensation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Spermatorrhea | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Gambling | Social circumstances | MedDRA | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| Male |
|
| OG001 | Ropinirole PR | Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR. |
|
|
Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR. |
|
|
Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
|
|
Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR. |
|
|
|
|
Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
|
|
Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
|
|
|
|
Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR. |
|
|
| OG001 |
| Ropinirole PR |
Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR. |
|
|
| Ropinirole PR |
Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR. |
|
|
|
|