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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00174239
First received: September 9, 2005
Last updated: May 24, 2007
Last verified: May 2007
  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
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:
  • 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
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 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
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:
No publications provided

ClinicalTrials.gov 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
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa
Levodopa
Carbidopa, levodopa drug combination
Cabergoline
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014