Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease. - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00174239

Purpose

The study will assess the relative benefit of cabergoline vs carbidopa/levodopa therapy in treating nighttime problems of Parkinson Disease.

Condition	Intervention	Phase
Parkinson Disease	Drug: cabergoline Drug: controlled-release levodopa / carbidopa	Phase IV

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

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Cabergoline Cabergoline diphosphate Carbidopa Sinemet

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Double-Blind, Randomized, Comparative Study of Cabaser and Sinemet CR For The Treatment Of Nocturnal Disability In Levodopa -Treated Parkinson's Disease Patients.

Further study details as provided by Pfizer:

Primary Outcome Measures:

PDSS, UPDRS

Secondary Outcome Measures:

CGI, PGI, Epworth Sleepiness Scale, PDQ-39

Estimated Enrollment:	220
Study Start Date:	July 2004
Study Completion Date:	September 2005

Detailed Description:

The trial was terminated prematurely June 26, 2005 due to the inability to re-supply study drug for the planned number of subjects. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Idiopathic Parkinson Disease
Must be experiencing sleep akinesia

Exclusion Criteria:

Current treatment with other dopamine agonists
Nocturnal hallucinations
Dementia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174239

Locations

Australia, New South Wales
Pfizer Investigational Site
WESTMEAD, New South Wales, Australia
Australia, Queensland
Pfizer Investigational Site
Brisbane, Queensland, Australia
Italy
Pfizer Investigational Site
Padova, Italy
Pfizer Investigational Site
Palermo, Italy
Pfizer Investigational Site
Bologna, Italy
Pfizer Investigational Site
Bolzano, Italy
Pfizer Investigational Site
Napoli, Italy
Pfizer Investigational Site
Roma, Italy
Italy, is
Pfizer Investigational Site
Loc. Camerelle - Pozzilli, is, Italy
Italy, Ragusa
Pfizer Investigational Site
Vittoria, Ragusa, Italy
Spain
Pfizer Investigational Site
Barcelona, Spain
Pfizer Investigational Site
Madrid, Spain
Pfizer Investigational Site
Sevilla, Spain
Spain, Asturias
Pfizer Investigational Site
Oviedo, Asturias, Spain

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Study ID Numbers:	A7231001
Study First Received:	September 9, 2005
Last Updated:	May 24, 2007
ClinicalTrials.gov Identifier:	NCT00174239
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Levodopa
Ganglion Cysts
Basal Ganglia Diseases
Carbidopa
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases

Dopamine
Parkinson Disease
Movement Disorders
Sinemet
Parkinsonian Disorders
Cabergoline

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs

Nervous System Diseases
Antiparkinson Agents
Dopamine Agents
Dopamine Agonists
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009