Special Survey on Parkinson's Disease (PD) Patients Without Concomitant Use of L-Dopa

The survey is conducted to collect safety and effectiveness information in Parkinson's Disease patients treated with Pramipexole without concomitant L-Dopa supplementation in the daily clinical settings in Japan.

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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

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site 11, Akita, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with Parkinson's disease who do not receive L-Dopa supplementation

Exclusion criteria

Patients should have been treated according to the Japanese insert slip

Treatment and study plan

Primary outcomes

Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events

Time frame: during 36 months

The aim of this Post Marketing Surveillance (PMS) was to obtain safety data in Parkinson's disease (PD) patients without concomitant use of levodopa for 3 years.

Secondary outcomes

Clinical Global Impression of Improvement

Time frame: after 36 months treatment

Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score

Time frame: Baseline and at 36 months (or at the time of discontinuation)

Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement.
Change From Baseline in Modified Hoehn & Yahr Rating Scale

Time frame: Baseline and at 36 months (or at the time of discontinuation)

A severity of PD symptom are assessed by Modified Hoehn & Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Pramipexole Special Survey on Patients Without Concomitant Use of L-Dopa

Important dates

Study start: 2004
Primary completion: 2009
First posted: Feb 13, 2008
Registry last updated: Jun 6, 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.

Published trials that share one or more normalized conditions with this study.

Completed