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

Phase 4TerminatedNCT00174239

Pfizer220 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

220

Conditions

Parkinson Disease

Interventions

cabergolineDRUG

controlled-release levodopa / carbidopaDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (14)

Pfizer Investigational Site

Westmead, New South Wales, Australia

Pfizer Investigational Site

Brisbane, Queensland, Australia

Pfizer Investigational Site

Loc. Camerelle - Pozzilli, IS, Italy

Outcomes

Primary Outcomes

PDSS, UPDRS

Secondary Outcomes

CGI, PGI, Epworth Sleepiness Scale, PDQ-39

Data from ClinicalTrials.gov

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