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

September 22, 2014 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

442

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Idiopathic PD patients recruited at office-based neurologists, psychiatrists or physicians in special neurological clinics

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Idiopathic PD patients
Drug: Pramipexole
Other Names:
  • Sifrol®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in dosing details of Pramipexole
Time Frame: up to 21 months
up to 21 months
Occurrence and clinical course of Parkinson Disease (PD) motor symptoms
Time Frame: up to 21 months
up to 21 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Kinetic Tremor
Time Frame: up to 21 months
Spiral test with at least five rotations from the centre to the edge in blinded fashion
up to 21 months
Change in dosing details of L-Dopa
Time Frame: up to 21 months
up to 21 months
Global Assessment of tolerability by investigator on 4-point scale
Time Frame: after 21 months
after 21 months
Global assessment of efficacy by investigator on a 4-point scale
Time Frame: after 21 months
after 21 months
Number of patients with adverse drug reactions
Time Frame: up to 21 months
up to 21 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

September 22, 2014

First Submitted That Met QC Criteria

September 22, 2014

First Posted (Estimate)

September 25, 2014

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 22, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 248.539

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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