First Presentation of Parkinson Disease Patients to Neurologist

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00802178
First received: December 3, 2008
Last updated: March 14, 2014
Last verified: March 2014
  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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00802178

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

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00802178     History of Changes
Other Study ID Numbers: 248.613
Study First Received: December 3, 2008
Results First Received: September 30, 2009
Last Updated: March 14, 2014
Health Authority: Croatia: Agency for Medicinal Product and Medical Devices
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
Hungary: National Institute of Pharmacy
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
European Union: European Medicines Agency
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health

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

ClinicalTrials.gov processed this record on April 21, 2014