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First Presentation of Parkinson Disease Patients to Neurologist

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00802178
First Posted: December 4, 2008
Last Update Posted: April 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boehringer Ingelheim
  Purpose
In this study information is gathered about the treatment of Parkinson patients who present themselves in a neurological practice for the first time

Condition
Parkinson Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CEE PMSS (Central Eastern European Post-Marketing Surveillance Study) First Presentation of Mirapexin in Parkinson Patients

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated [ Time Frame: 4 - 8 weeks ]

    Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as "good" on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor.

    De-novo patients were identified by:

    those who were referred: - if 'Reason for Referral' = 'initiation of therapy' or for 'diagnostic reason' and for those not referred: - if initial pharmacotherapy = 'Mirapexin® monotherapy' (i.e., no other anti Parkinson Disease (PD) therapy)



Secondary Outcome Measures:
  • Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I [ Time Frame: Baseline and 4 to 8 weeks ]
    Change in UPDRS Part I score from baseline to final visit. The score ranging from 0-16 (0= no disability, 16= maximum disability)

  • Change From Baseline in UPDRS Part III [ Time Frame: Baseline and 4 - 8 weeks ]
    Change in UPDRS Part III score from baseline to final visit. Score ranging from 0 - 108 (0= no disability, 108 = worst disability).

  • Global Clinical Assessments of Efficacy of Mirapexin® for All Patients [ Time Frame: 4 - 8 weeks ]
    Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as "good" on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor.


Enrollment: 2448
Study Start Date: February 2006
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
neurogologists
Criteria

Inclusion Criteria:

- Parkinson Disease patients presenting to neurologist for first time

Exclusion Criteria:

- Hypersensitivity to the active substance or to any of the excipients

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00802178


  Show 311 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00802178     History of Changes
Other Study ID Numbers: 248.613
First Submitted: December 3, 2008
First Posted: December 4, 2008
Results First Submitted: September 30, 2009
Results First Posted: November 20, 2009
Last Update Posted: April 11, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases