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.)
Information provided by:
Pfizer Identifier:
First received: September 9, 2005
Last updated: May 24, 2007
Last verified: May 2007
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

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.

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

Inclusion Criteria:

  • Idiopathic Parkinson Disease
  • Must be experiencing sleep akinesia

Exclusion Criteria:

  • Current treatment with other dopamine agonists
  • Nocturnal hallucinations
  • Dementia
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00174239

Australia, New South Wales
Pfizer Investigational Site
Westmead, New South Wales, Australia
Australia, Queensland
Pfizer Investigational Site
Brisbane, Queensland, Australia
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
Pfizer Investigational Site
Oviedo, Asturias, Spain
Pfizer Investigational Site
Barcelona, Spain
Pfizer Investigational Site
Madrid, Spain
Pfizer Investigational Site
Sevilla, Spain
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information: Identifier: NCT00174239     History of Changes
Other Study ID Numbers: A7231001 
Study First Received: September 9, 2005
Last Updated: May 24, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on April 27, 2016