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

Primary Purpose

Parkinson Disease

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
cabergoline
controlled-release levodopa / carbidopa
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Idiopathic Parkinson Disease Must be experiencing sleep akinesia Exclusion Criteria: Current treatment with other dopamine agonists Nocturnal hallucinations Dementia

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

PDSS, UPDRS

Secondary Outcome Measures

CGI, PGI, Epworth Sleepiness Scale, PDQ-39

Full Information

First Posted
September 9, 2005
Last Updated
May 24, 2007
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00174239
Brief Title
Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease.
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 Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Terminated
Why Stopped
See Detailed Description for termination reason.
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
220 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cabergoline
Intervention Type
Drug
Intervention Name(s)
controlled-release levodopa / carbidopa
Primary Outcome Measure Information:
Title
PDSS, UPDRS
Secondary Outcome Measure Information:
Title
CGI, PGI, Epworth Sleepiness Scale, PDQ-39

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Idiopathic Parkinson Disease Must be experiencing sleep akinesia Exclusion Criteria: Current treatment with other dopamine agonists Nocturnal hallucinations Dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
Pfizer Investigational Site
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Pfizer Investigational Site
City
Loc. Camerelle - Pozzilli
State/Province
IS
Country
Italy
Facility Name
Pfizer Investigational Site
City
Vittoria
State/Province
Ragusa
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bologna
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bolzano
Country
Italy
Facility Name
Pfizer Investigational Site
City
Napoli
Country
Italy
Facility Name
Pfizer Investigational Site
City
Padova
Country
Italy
Facility Name
Pfizer Investigational Site
City
Palermo
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
Country
Italy
Facility Name
Pfizer Investigational Site
City
Oviedo
State/Province
Asturias
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
Country
Spain
Facility Name
Pfizer Investigational Site
City
Sevilla
Country
Spain

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7231001&StudyName=Study+Of+Cabaser+and+Sinemet+CR+For+The+Treatment+Of+Nighttime+Symptoms+Associated+With+Parkinson%27s+Disease%2E
Description
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Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease.

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