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

This study is ongoing, but not recruiting participants.

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00613301

Purpose

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.

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 Levodopa

U.S. FDA Resources

Study Type:	Observational
Official Title:	BI-Sifrol Tablets Protocol to Implement Special Survey (Survey on Patients Without Concomitant Use of L-Dopa)

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: 3 Years ]

Estimated Enrollment:	300
Study Start Date:	February 2004
Estimated Primary Completion Date:	June 2009 (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 who do not receive L-Dopa supplementation

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613301

Show 164 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:	248.549
Study First Received:	January 31, 2008
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00613301
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Levodopa
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Dihydroxyphenylalanine

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 16, 2009