Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease

September 22, 2014 updated by: Boehringer Ingelheim

Observation of the Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease

Assessment of daily maintenance dose of Sifrol®, L-dopa sparing effect, effect on tremor, depression, anhedonia and tolerability

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

657

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

Patients with advanced idiopathic Parkinson's diease recruited at specialist practices and hospitals

Description

Inclusion Criteria:

  • Patients with advanced idiopathic Parkinson's disease for whom combined treatment with Sifrol and L-dopa was indicated

Exclusion Criteria:

  • NA

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parkinson's disease patients
Drug: Pramipexole
Other Names:
  • Sifrol®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cumulative daily doses of Sifrol®
Time Frame: up to 8 weeks
Changes in the doses between visits are evaluated using Wilcoxon's signed rank test
up to 8 weeks
Changes in cumulative daily doses of L-dopa
Time Frame: up to 8 weeks
Changes in the doses between visits are evaluated using Wilcoxon's signed rank test
up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with adverse events
Time Frame: up to 8 weeks
up to 8 weeks
Change from Baseline in Short Parkinson Evaluation Scale (SPES) total score
Time Frame: Baseline, after 8 weeks
Baseline, after 8 weeks
Change from Baseline in SPES subscales
Time Frame: Baseline, after 8 weeks
Psychopathological disturbances, Activities of daily living, Evaluation of motor function, Tremor, Resting Tremor, Postural tremor, Complications of therapy
Baseline, after 8 weeks
Change from Baseline in Snaith-Hamilton-Pleasure-Scale total score
Time Frame: Baseline, after 8 weeks
patients with SPES depression >= 2
Baseline, after 8 weeks
Change from Baseline in Tremor Impact Scale (TIS-D) total score
Time Frame: Baseline, after 8 weeks
Baseline, after 8 weeks
Change from Baseline in global Parkinson's Disease (PD) symptoms
Time Frame: Baseline, after 8 weeks
Akinesia, anhedonia, depression, dyskinesia, motor fluctuation, cognitive disturbances, rigor and tremor
Baseline, after 8 weeks
Global assessment of efficacy by investigator on a 5-point scale
Time Frame: after 8 weeks
after 8 weeks
Global assessment of tolerability by investigator on a 5-point scale
Time Frame: after 8 weeks
after 8 weeks
Number of patients with adverse drug reactions
Time Frame: up to 8 weeks
up to 8 weeks

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

October 1, 1998

Primary Completion (Actual)

October 1, 1999

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

  • 248.360

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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