Parkinson's Disease
Conditions
Keywords
Parkinson's disease, Pramipexole
Brief summary
1. In order to observe the benefit, side effects, and patient preference of Mirapex ER when used in once-daily (QD) or twice-daily (BID) dosing 2. In order to estimate the conversion rate of dopamine agonists into Mirapex ER
Detailed description
1. Study subjects : Parkinson disease who are on Requip or Mirapex and are considering to change into Mirapex ER 2. Cross over study design: * Group 1: Once daily dose for 2 month then into BID in divided dose for 2 months * Group 2: BID in divided dose for 2 months then into QD dose for 2 months 3. Dose adjustment may be done in the first 4 weeks. 4. Compare the benefit, side effects, and patient preference between the QD vs BID dosing
Interventions
DRUGMirapex ER
Change Requip or Mirapex to Mirapex ER
Sponsors
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 30-80 2. Parkinson disease 3. On dopamine agonists (Requip or Mirapex) and are considering to change into Mirapex ER 4. On stable antiparkinsonian medication for at least 4 weeks 5. Who signed consent to the study
Exclusion criteria
1. Who are on less than 2 mg of Requip or 0.375 mg of Mirapex 2. Who have dementia, psychosis, major depression and other serious neurological or medical problems 3. Who are allergic to the similar medications 4. Who has history of heavy metal poisoning 5. Who were on othe clinical trials of other medications within the last 4 weeks 6. Who are pregnant or lactating 7. Who are considered not eligible by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient preference | 4 months | Overall preference in QD versus BID |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep problems | 2 months at each arm | Parkinson's disease sleep scale (PDSS) Excessive daytime sleepiness scale(ESS) |
| Motor UPDRS and HY stage | 2months at each arm | — |
| Side effects | 2 months at each arm | Rating scale (0\ 10): Nausea, Dizziness, Somnolence, Headache, Constipation, Dyspepsia, Fatigue, Hallucination, Edema, Dry mouth,Others |
| Motor complications | 2 months at each arm | Visual rating scale for off severity, dyskinesia severity Duration - off duration, dyskinesia duration |
| Preference in each factor | 4 months | Preference of QD versus BID in each factor: off duration, off severity, dyskinesia duration, dyskinesia severity, on quality, adverse events, sleep quality, convenience |
| Patient choice | 4 months | Patient choice in QD or BID Reason for the choice |
| Patient global impression for improvement | 2 months at each arm | — |
Countries
South Korea
Contacts
Primary ContactBeom S Jeon, MD, PhD
Backup ContactJi Young Yun, MD
Outcome results
None listed