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

NCT ID: NCT00174239

Last Updated: 2007-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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cabergoline

Intervention Type DRUG

controlled-release levodopa / carbidopa

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Idiopathic Parkinson Disease
* Must be experiencing sleep akinesia

Exclusion Criteria

* Current treatment with other dopamine agonists
* Nocturnal hallucinations
* Dementia
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Westmead, New South Wales, Australia

Site Status

Pfizer Investigational Site

Brisbane, Queensland, Australia

Site Status

Pfizer Investigational Site

Loc. Camerelle - Pozzilli, IS, Italy

Site Status

Pfizer Investigational Site

Vittoria, Ragusa, Italy

Site Status

Pfizer Investigational Site

Bologna, , Italy

Site Status

Pfizer Investigational Site

Bolzano, , Italy

Site Status

Pfizer Investigational Site

Napoli, , Italy

Site Status

Pfizer Investigational Site

Padua, , Italy

Site Status

Pfizer Investigational Site

Palermo, , Italy

Site Status

Pfizer Investigational Site

Roma, , Italy

Site Status

Pfizer Investigational Site

Barcelona, Barcelona, Spain

Site Status

Pfizer Investigational Site

Madrid, Madrid, Spain

Site Status

Pfizer Investigational Site

Oviedo, Principality of Asturias, Spain

Site Status

Pfizer Investigational Site

Seville, Sevilla, Spain

Site Status

Countries

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Australia Italy Spain

Related Links

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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

To obtain contact information for a study center near you, click here.

Other Identifiers

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A7231001

Identifier Type: -

Identifier Source: org_study_id