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Study subjects : Parkinson disease who are on Requip or Mirapex and are considering to change into Mirapex ER
Cross over study design:
Dose adjustment may be done in the first 4 weeks.
Compare the benefit, side effects, and patient preference between the QD vs BID dosing
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Give QD dose first then BID dosing |
|
| Group 2 | Active Comparator | Give BID dosing and then QD dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirapex ER | Drug | Change Requip or Mirapex to Mirapex ER |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient preference | Overall preference in QD versus BID | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Motor complications | Visual rating scale for off severity, dyskinesia severity Duration - off duration, dyskinesia duration | 2 months at each arm |
| Sleep problems | Parkinson's disease sleep scale (PDSS) Excessive daytime sleepiness scale(ESS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beom S Jeon, MD, PhD | Contact | 82-2-2072-2876 | brain@snu.ac.kr | |
| Ji Young Yun, MD | Contact | 82-2-2072-0359 | dream-yoon@hanmail.net |
| 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 | Recruiting | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20110012 | Background | Jenner P, Konen-Bergmann M, Schepers C, Haertter S. Pharmacokinetics of a once-daily extended-release formulation of pramipexole in healthy male volunteers: three studies. Clin Ther. 2009 Nov;31(11):2698-711. doi: 10.1016/j.clinthera.2009.10.018. | |
| 20669265 | Background | Rascol O, Barone P, Hauser RA, Mizuno Y, Poewe W, Schapira AH, Salin L, Sohr M, Debieuvre C; Pramipexole Switch Study Group. Efficacy, safety, and tolerability of overnight switching from immediate- to once daily extended-release pramipexole in early Parkinson's disease. Mov Disord. 2010 Oct 30;25(14):2326-32. doi: 10.1002/mds.23262. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 13, 2017 | |
| Reset | Oct 31, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 13, 2017 | Oct 31, 2017 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 2 months at each arm |
| Motor UPDRS and HY stage | 2months at each arm |
| Side effects | Rating scale (0~10): Nausea, Dizziness, Somnolence, Headache, Constipation, Dyspepsia, Fatigue, Hallucination, Edema, Dry mouth,Others | 2 months at each arm |
| Patient global impression for improvement | 2 months at each arm |
| Preference in each factor | Preference of QD versus BID in each factor: off duration, off severity, dyskinesia duration, dyskinesia severity, on quality, adverse events, sleep quality, convenience | 4 months |
| Patient choice | Patient choice in QD or BID Reason for the choice | 4 months |
| 28265478 | Derived | Yun JY, Kim YE, Yang HJ, Kim HJ, Jeon B. Twice-Daily versus Once-Daily Pramipexole Extended Release Dosage Regimens in Parkinson's Disease. Parkinsons Dis. 2017;2017:8518929. doi: 10.1155/2017/8518929. Epub 2017 Feb 7. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |