Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson’s Disease.
Overview
The study will assess the relative benefit of cabergoline vs carbidopa/levodopa therapy in treating nighttime problems of Parkinson Disease.
Full Title of Study: “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 Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double
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.
Interventions
- Drug: cabergoline
- Drug: controlled-release levodopa / carbidopa
Clinical Trial Outcome Measures
Primary Measures
- PDSS, UPDRS
Secondary Measures
- CGI, PGI, Epworth Sleepiness Scale, PDQ-39
Participating 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: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Pfizer
- Overall Official(s)
- Pfizer CT.gov Call Center, Study Director, Pfizer
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.