Transdermal Rotigotine User Surveillance Study - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00599339

Purpose

This study will be conducted in an observational multiple-cohort design aimed at acquiring clinical, treatment, health status, and economic data. patients with early-stage Parkinson's disease (PD) will be enrolled.

Condition
Idiopathic Parkinson Disease

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Rotigotine

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	A Naturalistic, Multisite, Observational Study of Rotigotine Transdermal Patch and Other Currently Prescribed Therapies in Patients With Early-Stage Idiopathic Parkinson's Disease

Further study details as provided by UCB:

Primary Outcome Measures:

Observational study, early-stage idiopathic Parkinson's Disease [ Time Frame: 33 months ]
the objectives of this study are to examine the current management and outcomes of patients with Parkinson's disease (PD) through an observational multiple-cohort design. [ Time Frame: 33 months per patient ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2000
Study Start Date:	June 2006
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Rotigotine
2 Other dopamine-agonists
3 L-Dopa

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Primary Care

Criteria

Inclusion Criteria:

Patients with early-stage idiopathic Parkinson's Disease requiring dopaminergic monotherapy (rotigotine, other dopamine agonists or levodopa) at study onset.

Exclusion Criteria:

Patients who are unable to comply with study requirements.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599339

Show 78 Study Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	SP854
Study First Received:	January 10, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00599339
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB:

Rotigotine
Neupro

Study placed in the following topic categories:

Dopamine
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
N 0437

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases

Dopamine Agents
Dopamine Agonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009