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OpenTrials
Completed

NCT Number: NCT00802178

First Presentation of Parkinson Disease Patients to Neurologist

In this study information is gathered about the treatment of Parkinson patients who present themselves in a neurological practice for the first time

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site, Bjelovar, Croatia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parkinson Disease patients presenting to neurologist for first time

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

CEE PMSS (Central Eastern European Post-Marketing Surveillance Study) First Presentation of Mirapexin in Parkinson Patients

Important dates

Study start
2006
Primary completion
2007
First posted
Dec 4, 2008
Registry last updated
Apr 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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