Parkinson's Disease
Conditions
Brief summary
The purpose of this study is to determine whether pramipexole and bromocriptine are effective in the treatment of non-motor symptoms in Parkinson's Disease.
Detailed description
PRIMARY OBJECTIVE Evaluate the Improvement of Nonmotor symptom scale (NMSS) between Pramipexole and Bromocriptine for early Parkinson's disease during 24-week treatment SECONDARY OBJECTIVE * Evaluate the improvement for Depression which is one of the Nonmotor symptoms * Evaluate the improvement of clinical symptoms between two groups * Evaluate the improvement of Quality of Life between two groups
Interventions
DRUGpramipexole
pramipexole
DRUGBromocriptine
bromocriptine
Sponsors
Sandoz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Parkinson's disease patients in accordance with UK Queensquare Brain Bank * modified Hoehn & Yahr stage \<3 * Dopamine agents(Levodopa, dopamine agonists) naive patients, or the patients who have discontinued the agents at least four weeks before the screening in case of using the dopamine agents are administered before.
Exclusion criteria
* K-MMSE\<24 * History of drug-induced Parkinsonism * secondary parkinsonism * History of schizophrenia or hallucination * Requirement of treatment with anti-depressants due to depressive disorder * Pregnant and/or breeding women * Renal inadequacy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| K-NMSS | 24 weeks | Evaluate The total and each category score of K-NMSS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| K-MADRS | 24 weeks | Evaluate the Improvement of the depression refering to the total score of K-MADRS |
| UPDRS I/II/III | 24 weeks | Evaluate the improvement of UPDRS I/II/III |
| K-PDQ39 | 24 weeks | Evaluate the improvement of Patient's QOL |
Countries
South Korea
Outcome results
None listed