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

NCT ID: NCT02248181

Last Updated: 2014-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

442 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Idiopathic PD patients

Pramipexole

Intervention Type DRUG

Interventions

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Pramipexole

Intervention Type DRUG

Other Intervention Names

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Sifrol®

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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248.539

Identifier Type: -

Identifier Source: org_study_id

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