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

This study has been terminated.
(See Detailed Description for termination reason.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00174239
First Posted: September 15, 2005
Last Update Posted: May 25, 2007
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.
Information provided by:
Pfizer
  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 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: September 9, 2005
First Posted: September 15, 2005
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