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

Parkinson Disease Clinical Trial

Official title:

Management of Parkinson's Disease Patients at Their First Visits in a Neurological Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248207
• Other study ID #: 248.527
• Status: Completed
• Phase: N/A
• First received: September 22, 2014
• Last updated: September 22, 2014
• Start date: January 2003

Study information

• Verified date: September 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1293
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Pramipexole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Assessment of efficacy by investigator on a 4-point scale		after 8 weeks	No
Primary	Change from Baseline in actual Parkinson symptoms		Baseline, after 8 weeks	No
Primary	Global Assessment of tolerability by investigator on a 4-point scale		after 8 weeks	No
Secondary	Number of patients with adverse drug reactions		up to 8 weeks	No

External Links

•   Link