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.”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: cabergoline
• Drug: controlled-release levodopa / carbidopa

Primary Measures

• PDSS, UPDRS

Secondary Measures

• CGI, PGI, Epworth Sleepiness Scale, PDQ-39

Inclusion Criteria:

• Idiopathic Parkinson Disease
• Must be experiencing sleep akinesia

Exclusion Criteria:

• Current treatment with other dopamine agonists
• Nocturnal hallucinations
• Dementia

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00174239

Study ID Number: A7231001

ClinicalTrials.gov Identifier: NCT00174239

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Link to ClinicalStudyResults.org Posting