a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease Patients

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, multicenter, non-interventional, prospective observational study. we collect the safety information of pramipexole over 12w treatment. Parkinson disease patients with different severity who have already used pramipexole could be observed in this study. In the whole observation period, treatment decision was determined by physician and patient completely. The safety endpoint is AE(Adverse Event), SAE(Serious Adverse Event), patient withdraw, laboratory test.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Pramipexole

Criteria

Inclusion criteria:

1. Diagnosed as idiopathic PD (Parkinson' disease) according to UK brain bank criteria

2. Age: from 30 to 75 years old

3. Stage I-IV of revised Hoehn-Yahr standards

4. With current use of pramipexole

5. Informed consent signed by every subject

Exclusion criteria:

1. Diagnosis of Parkinson¿s syndrome

2. Current use of psychotolytic medications

3. Allergic to pramipexole or any other ingredient of pramipexole

4. Female patients in pregnancy and lactation

5. Patients who were participating in other clinical studies by signing relevant informed consent or who received other investigational drugs within 30 days prior to the study