Post Marketing Surveillance Study of Sifrol® in Patients With Idiopathic Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Post Marketing Surveillance Study of Sifrol® - Monotherapy in Patients With Idiopathic Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248181
• Other study ID #: 248.539
• Status: Completed
• Phase: N/A
• First received: September 22, 2014
• Last updated: September 22, 2014
• Start date: February 2004

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 document pramipexole dosing during monotherapy, occurrence of fluctuations and dyskinesias, dose increases after deterioration of Parkinson's disease (PD) symptoms, assessment of the reasons for add-on treatment with L-Dopa and dosing of pramipexole and L-Dopa when given concomitantly.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of early stage idiopathic Parkinson's Disease

• No pre-treatment with any dopaminergic treatment (de novo patients), or Pre-treatment with L-Dopa at doses of < 200 mg/d

Exclusion Criteria:

• Treating physicians are asked to consider the regulation described in the Summary of Product Characteristics (SmPC) for the treatment with pramipexole

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	Change in dosing details of Pramipexole		up to 21 months	No
Primary	Occurrence and clinical course of Parkinson Disease (PD) motor symptoms		up to 21 months	No
Secondary	Assessment of Kinetic Tremor	Spiral test with at least five rotations from the centre to the edge in blinded fashion	up to 21 months	No
Secondary	Change in dosing details of L-Dopa		up to 21 months	No
Secondary	Global Assessment of tolerability by investigator on 4-point scale		after 21 months	No
Secondary	Global assessment of efficacy by investigator on a 4-point scale		after 21 months	No
Secondary	Number of patients with adverse drug reactions		up to 21 months	No

External Links

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