Non-Interventional Observational Study With Pramipexole: Impact on Non-Motor Symptoms in Parkinson's Disease - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00539214

Purpose

In this German non-interventional observational study 1755 patients diagnosed with Parkinson's disease (PD) will be investigated by 585 specialists (neurologists or neurologist and psychiatrists) across Germany.

Both early and advanced PD patients with or without previous antiparkinsonian treatment are eligible for this study, if it is planned to initiate a new therapy with pramipexole or to switch to pramipexole from a previously given, insufficient dopamine agonist therapy.

Only marketed substance of Sifrol® will be used throughout the study. Sifrol treatment will be started and up-titrated as per Summary of Product Characteristics (SPC). Three visits are planned to be documented in this PMS study within a total observation period of 9-16 weeks. Evaluations and visits are to be carried out and documented only if part of routine medical practice.

The objectives of this study are:

To compare the effect of pramipexole on depressive symptoms in early and advanced PD patients.
To evaluate the course of depressive symptoms measured with UPDRS Part I (mentation, behavior and mood) and with HADS-D under pramipexole treatment.
To investigate whether improvement of depressive symptoms is linked to improvement in motor function (UPDRS Part III).

Condition	Phase
Parkinson Disease	Phase IV

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

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Pramipexol Pramipexole dihydrochloride

U.S. FDA Resources

Study Type:	Observational
Official Title:	Observational Non-Interventional Study on Non-Motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Estimated Enrollment:	1755
Estimated Study Completion Date:	June 2008

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Idiopathic Parkinson's disease with or without fluctuations
Indication for treatment with Sifrol®
Male or female patients of age
Presence of at least mild depressive symptoms (as judged by the treating physician)
Ability to reliably complete a self-rating scale (HADS)

Exclusion Criteria:

Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients
Ongoing treatment with Sifrol®

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539214

Show 317 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

Boehringer Ingelheim Pharmaceuticals

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	248.639
Study First Received:	September 28, 2007
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00539214
Health Authority:	United States: Food and Drug Administration

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
Pramipexol

Additional relevant MeSH terms:

Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Antiparkinson Agents

Dopamine Agonists
Protective Agents
Pharmacologic Actions
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009