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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802178

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Croatia
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Bjelovar, Croatia
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Dubrovnik, Croatia
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Gospić, Croatia
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Karlovac, Croatia
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Požega, Croatia
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Pula, Croatia
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Rijeka, Croatia
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Split, Croatia
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Šibenik, Croatia
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Brandýs n. Orlicí, Czech Republic
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Brno, Czech Republic
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Cheb, Czech Republic
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Zilina, Slovakia
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Zilina, Slovakia
Slovenia
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Ljubljana, Slovenia
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Ljubljana, Slovenia
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Ljubljana, Slovenia
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Ljubljana, Slovenia
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Ljubljana, Slovenia
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Maribor, Slovenia
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Maribor, Slovenia
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Maribor, Slovenia
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Maribor, Slovenia
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Sempeter pri Gorici, Slovenia
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 July 31, 2014