Special Survey on PD Patients Treated Long-Term Use of Pramipexole

This study is ongoing, but not recruiting participants.

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00615914

Purpose

The survey is conducted to collect safety and effectiveness information on the use of Pramipexole for long time of period in daily clinical settings in Japan.

Condition
Parkinson Disease

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:	BI-Sifrol Tablets Protocol to Implement Special Survey (Survey on Long-Term Use)

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Safety (Adverse event, Laboratory test) Efficacy (UPDRS part III, Clinical groval impression) [ Time Frame: 18 Months ]

Estimated Enrollment:	1500
Study Start Date:	February 2004
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with Parkinson's disease

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615914

Show 273 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	248.547
Study First Received:	January 31, 2008
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00615914
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Central Nervous System Diseases

Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
Pramipexol

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009