Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study subjects : Parkinson disease who are on Ropinirole immediate release or Pramipexole immediate release and are considering to change into Ropinirole prolonged release
Cross over study design:
Dose adjustment may be done in the first 4 weeks.
Compare the benefit,side effects, and patient preference between the once daily vs twice daily dosing.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropinirole PR QD first, then BID | Active Comparator | Give Roipinirole prolonged release (PR) once-daily (QD) dose first, then twice-daily (BID) dosing |
|
| Ropinirole PR BID first, and then QD | Active Comparator | Give Ropinirole prolonged release (PR) twice-daily (BID) dosing, and then once-daily (QD) dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropinirole Prolonged release | Drug | Change Ropinirole immediate release or Pramipexole immediate release to Ropinirole prolonged release (PR) once-daily or twice-daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Preference | Patient preference between once-daily and twice-daily regimen | After 16 weeks or at last visit for early completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks for each arm or at last visit |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Beom S Jeon, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea | |||
| Boramae City Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19768728 | Background | Lyons KE, Pahwa R. An open-label conversion study of pramipexole to ropinirole prolonged release in Parkinson's disease. Mov Disord. 2009 Oct 30;24(14):2121-7. doi: 10.1002/mds.22750. | |
| 18768106 | Background | Stocchi F, Hersh BP, Scott BL, Nausieda PA, Giorgi L; Ease-PD Monotherapy Study Investigators. Ropinirole 24-hour prolonged release and ropinirole immediate release in early Parkinson's disease: a randomized, double-blind, non-inferiority crossover study. Curr Med Res Opin. 2008 Oct;24(10):2883-95. doi: 10.1185/03007990802387130. Epub 2008 Sep 2. |
Not provided
Not provided
A total of 82 patients with PD were enrolled in this study at two centers in Seoul, Korea.
The first subject was enrolled in September 2009 and the last subject completed the study in December 2010.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ropinirole PR-Once Daily First, Then Twice Daily | Ropinirole prolonged release(PR) once daily in first intervention period and twice daily in second intervention period (without washout period) |
| FG001 | Ropinirole PR-Twice Daily First, Then Once Daily | Ropinirole prolonged release(PR) twice daily in first intervention period and once daily in second intervention period (without washout period) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
|
| |||||||||||||||||||||
| Second Intervention |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive once daily first and twice daily first. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Patient Preference | Patient preference between once-daily and twice-daily regimen | Primary outcome measure was the preference of the subjects between once-daily versus twice-daily of RPR at the completion or at early completion after crossover. 61 of participants completing period with study intervention. | Posted | Number | participants | After 16 weeks or at last visit for early completion |
|
8 weeks for each arm or at last visit
Not provided
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 | Once-daily of Ropinirole PR | Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
This study was designed to open-label study. We cannot exclude the psychological effect of each regimen.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BS Jeon | Seoul National University Hospital | 82-2-2072-2876 | brain@snu.ac.kr |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 | 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. | 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. | 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. | 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. | 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. | 8 weeks for each arm or at last visit |
| Adverse Events | Patients who have adverse events | After 8 weeks in each arm or at last visit for early completion |
| Patients Who Have Global Impression for Improvement | Patients who have global impression for improvement for each dosing. | 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 | 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 | 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 | 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 | After 8 weeks in each arm or at last visit for early completion |
| Seoul |
| South Korea |
| 24004540 | Derived | Yun JY, Kim HJ, Lee JY, Kim YE, Kim JS, Kim JM, Jeon BS. Comparison of once-daily versus twice-daily combination of ropinirole prolonged release in Parkinson's disease. BMC Neurol. 2013 Sep 2;13:113. doi: 10.1186/1471-2377-13-113. |
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Out of indication |
|
| NOT COMPLETED |
|
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| No Preference |
No preference group |
|
|
| Secondary | 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. | Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. Once-daily or Twice-daily arm means clinical variables measured in once-daily or twice-daily regimen, respectively. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks for each arm or at last visit |
|
|
|
|
| Secondary | 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 | Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. Once-daily or twice-daily arm means clinical variables measured in once-daily or twice-daily regimen, respectively. | Posted | Mean | Standard Deviation | Scores on a scale | 8 weeks for each arm or at last visit |
|
|
|
|
| Secondary | Overall Quality of Sleep | Sleep questionnaire 1 for "Overall quality of sleep" Visual analogue scale: 0~10 Higher values represent worse overall sleep quality. | Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks for each arm or at last visit |
|
|
|
|
| Secondary | Nocturnal Off-symptoms | Sleep questionnaire 2 for "Nocturnal off-symptoms" Visual analogue scale: 0~10 Higher values represent worse nocturnal off-symptoms. | Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks for each arm or at last visit |
|
|
|
|
| Secondary | 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. | Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks for each arm or at last visit |
|
|
|
|
| Secondary | 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. | Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks in each arm or at last visit for early completion |
|
|
|
|
| Secondary | Compliance | Compliances after 8 weeks in each arm or at last visit for early completion. Compliance was calcuated by the percentage of used medication. | Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively. | Posted | Mean | Standard Deviation | percentage of used medication | 8 weeks for each arm or at last visit |
|
|
|
|
| Secondary | Adverse Events | Patients who have adverse events | Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively. | Posted | Number | participants | After 8 weeks in each arm or at last visit for early completion |
|
|
|
| Secondary | Patients Who Have Global Impression for Improvement | Patients who have global impression for improvement for each dosing. | The number of patient who completed the study and answered the questionnaire for global impression. | Posted | Number | participants | After 8 weeks in each arm or at last visit for early completion |
|
|
|
| Secondary | Patients Who Have Global Impression for Improvement to Duration of Motor Fluctuation | Patients who have global impression for improvement to duration of motor fluctuation | The number of patient who completed the study and answered the questionnaire for global impression to motor fluctuation duration. | Posted | Number | participants | After 8 weeks in each arm or at last visit for early completion |
|
|
|
| Secondary | 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 | The number of patient who completed the study and answered the questionnaire for global impression to motor fluctuation severity. | Posted | Number | participants | After 8 weeks in each arm or at last visit for early completion |
|
|
|
| Secondary | Patients Who Have Global Impression for Improvement to Duration of Dyskinesia | Patients who have global impression for improvement to duration of dyskinesia compared | The number of patient who completed the study and answered the questionnaire for global impression to dyskinesia duration. | Posted | Number | participants | After 8 weeks in each arm or at last visit for early completion |
|
|
|
| Secondary | Patients Who Have Global Impression for Improvement to Severity of Dyskinesia | Patients who have Global Impression for Improvement to Severity of Dyskinesia compared | The number of patient who completed the study and answered the questionnaire for global impression to dyskinesia severity. | Posted | Number | participants | After 8 weeks in each arm or at last visit for early completion |
|
|
|
| 0 |
| 61 |
| 33 |
| 61 |
| EG001 | Twice-daily of Ropinirole PR | Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period. | 0 | 61 | 28 | 61 |
| Dizziness | General disorders | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Aggravation of vivid dream or REM sleep behavior disorder | Nervous system disorders | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |