Primary Parkinson's disease
Conditions
Interventions
the dose will be added from the second weekend to the eighth week to 4. 5 mg/d(1.5 mg, tid)
maintain the dose during 12 weeks and reduce the dose during 1-4weeks
Group 1:Artane oral 1-2mg, tid,+ Mirapexin, 0.25 mg/d at beginning, and add to 1.0 mg/d at the end of the second week
Group 3:Artane oral 1-2mg, tid + Madopar, 62.5~500 mg, 2~4 times a day depends on the serious of disease + Mirapexin, the dose is same as group 1
Group 2:Artane oral 1-2mg, tid+ Benserazide-Levodopa (Madopar), oral 62.5~500 mg, 2~4 times a day depends on the serious of the disease
Sponsors
First Affiliated Hospital of Xinjiang Medical University
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Diagnosed primary parkinson's disease according to clinical diagnostic criteria of Hoehn-Yahr; (2) Aged 30 to 80 years old, no gender restriction; (3) The Hoehn-Yahr grade of "on" time is II-IV; (4) Have not taken the dopamine agonist at least in 15 days before enrolling the trial; (5) Levodopa and Peripheral Decarboxylase Inhibitors or other antiparkinsonism drugs (not dopamine receptor agonist) taken by patients have already reached the stable dosage at least 30 days; (6) The motor fluctuation characterized by "end-of-dose deterioration" or "wearing-off" caused by the optimum dose of Levodopa have existed at lease 30 days before enrolling the study; (7) The total "off" time is 2 to 6 hours an day (not including the morning stiffness); (8) Patient or nurse could write the family diary correctly, and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Allergy to Pramipexole or its any component; (2) With symptomatic Parkinson or Parkinson plus syndrome, dose-peak dyskinesias, postural hypotension, stereotactic surgery history of brain, neuroleptic malignant syndrome, non-traumatic rhabdomyolysis, schizophrenia, epileptic attack, or drug abuse; (3) Exist any laboratory abnormalities with clinical meanings or have other severe disease; (4) Can not complete the family diary or had low compliance history; (5) Had taken neuroleptics, parenteral ergot preparation, drugs may cause the extracorticospinal tract reaction or other investigational drugs in 30 days before baseline-time; (6) Had undertaken electric shock treatment in 30 days before baseline-time; (7) Female with gestation or lactation period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Daily life and movement motor function score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mental, action, feeling, and complete symptom scores; | — |
Countries
China
Contacts
Public ContactXinling Yang
Outcome results
None listed