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

Boehringer Ingelheim

Status: Completed

Conditions: Parkinson Disease

Treatments: Drug: pramipexole

Study type: Observational

Funder types: Industry

Identifiers

NCT01361009

248.682

Details and patient eligibility

About

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.

Full description

Purpose:

Enrollment: 2,017 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

2,017 participants in 1 patient group

pramipexole group

Description:

It's a open-label, non-intervention,observation post marketing surveillance to observe the safety and efficacy of pramipexole in real world.

Treatment:

Drug: pramipexole