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

Sponsor

Pfizer (Industry)

Overall Status

Terminated

CT.gov ID

NCT00174239

Collaborator

(none)

220

Enrollment

Locations

Duration (Months)

15.7

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: cabergoline Drug: controlled-release levodopa / carbidopa	Phase 4

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

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.

Study Start Date :

Jul 1, 2004

Actual Study Completion Date :

Sep 1, 2005

Outcome Measures

Primary Outcome Measures

PDSS, UPDRS []

Secondary Outcome Measures

CGI, PGI, Epworth Sleepiness Scale, PDQ-39 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Idiopathic Parkinson Disease
Must be experiencing sleep akinesia

Exclusion Criteria:

Current treatment with other dopamine agonists
Nocturnal hallucinations
Dementia

Contacts and Locations

Locations

	Site	City	State	Country
1	Pfizer Investigational Site	Westmead	New South Wales	Australia
2	Pfizer Investigational Site	Brisbane	Queensland	Australia
3	Pfizer Investigational Site	Loc. Camerelle - Pozzilli	IS	Italy
4	Pfizer Investigational Site	Vittoria	Ragusa	Italy
5	Pfizer Investigational Site	Bologna		Italy
6	Pfizer Investigational Site	Bolzano		Italy
7	Pfizer Investigational Site	Napoli		Italy
8	Pfizer Investigational Site	Padova		Italy
9	Pfizer Investigational Site	Palermo		Italy
10	Pfizer Investigational Site	Roma		Italy
11	Pfizer Investigational Site	Oviedo	Asturias	Spain
12	Pfizer Investigational Site	Barcelona		Spain
13	Pfizer Investigational Site	Madrid		Spain
14	Pfizer Investigational Site	Sevilla		Spain