Tolerability of Sifrol® in Ambulatory Patients Suffering From Parkinson's Disease

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: Pramipexole

• Registration Number: NCT02248207
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to obtain information about the co-operation of the different physician-colleagues in the treatment of patients with Parkinson's disease, both in private practices and clinics and about the primary treatment strategies in the pharmacotherapy of Parkinson's disease and to collect data on the tolerability of Sifrol® in ambulatory patients suffering from Parkinson's disease under routing conditions

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2003-11
• Status Verified: 2014-09
• Study First Submitted: 2014-09-22
• Study First Submitted QC: 2014-09-22
• Last Update Submitted: 2014-09-22
• Study First Posted: 2014-09-25
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1293

Inclusion Criteria

• Patients with Parkinson's disease who present to the specialist neurologist practice for the first time without or with referral and who are planned to receive or either be switched to Sifrol or continue the previously prescribed therapy with Sifrol® can be included in this observational study

Exclusion Criteria

• Neurologists are asked to consider the Summary of Product Characteristics (SPC) for Sifrol®

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parkinson Disease patients	Pramipexole	-

Primary Outcome Measures

Name	Time	Method
Global Assessment of efficacy by investigator on a 4-point scale	after 8 weeks
Change from Baseline in actual Parkinson symptoms	Baseline, after 8 weeks
Global Assessment of tolerability by investigator on a 4-point scale	after 8 weeks

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse drug reactions	up to 8 weeks