Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease.
The study will assess the relative benefit of cabergoline vs carbidopa/levodopa therapy in treating nighttime problems of Parkinson Disease...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: cabergoline
- Drug: controlled-release levodopa / carbidopa
Outcome Measures for this Clinical Trial
Primary Measures
- PDSS, UPDRS
Secondary Measures
- CGI, PGI, Epworth Sleepiness Scale, PDQ-39
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Pfizer Industry
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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.
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00174239
