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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00174239
Recruitment Status : Terminated (See Detailed Description for termination reason.)
First Posted : September 15, 2005
Last Update Posted : May 25, 2007
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: cabergoline Drug: controlled-release levodopa / carbidopa Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.
Study Start Date : July 2004
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. PDSS, UPDRS

Secondary Outcome Measures :
  1. CGI, PGI, Epworth Sleepiness Scale, PDQ-39

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Loc. Camerelle - Pozzilli, IS, Italy
Pfizer Investigational Site
Vittoria, Ragusa, Italy
Pfizer Investigational Site
Bologna, Italy
Pfizer Investigational Site
Bolzano, Italy
Pfizer Investigational Site
Napoli, Italy
Pfizer Investigational Site
Padova, Italy
Pfizer Investigational Site
Palermo, Italy
Pfizer Investigational Site
Roma, Italy
Spain
Pfizer Investigational Site
Oviedo, Asturias, Spain
Pfizer Investigational Site
Barcelona, Spain
Pfizer Investigational Site
Madrid, Spain
Pfizer Investigational Site
Sevilla, Spain
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00174239     History of Changes
Other Study ID Numbers: A7231001
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 25, 2007
Last Verified: May 2007

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Carbidopa
Cabergoline
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents
Dopamine Agonists
Adjuvants, Immunologic
Immunologic Factors