The Long Term Impact of Initiating Pramipexole Versus Levodopa in Early Parkinson's Disease (CALM-PD Cohort Study)
Terminated
- Conditions
- Parkinson's Disease
- Interventions
- Other: No intervention.
- Registration Number
- NCT00804479
- Lead Sponsor
- University of Rochester
- Brief Summary
To determine the long-term consequences (8 years) of initiating patients with Parkinson's disease on either pramipexole or levodopa. We hypothesize that patients initiating therapy with pramipexole compared with levodopa will demonstrate less self-reported disability as measured by the Modified Schwab and England (S/E) scale 8 years after randomization.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 222
Inclusion Criteria
- Available 301 subjects enrolled in the CALM-PD study.
Exclusion Criteria
- Those not enrolled in the CALM-PD study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description no treatment No intervention. Available 301 subjects enrolled in CALM-PD Available 82 subjects enrolled in CALM-PD imaging substudy
- Primary Outcome Measures
Name Time Method We hypothesize that patients initiating therapy with pramipexole compared with levodopa will demonstrate less self-reported disability as measured by the Modified Schwab and England. 8 years from date randomized in CALM study
- Secondary Outcome Measures
Name Time Method Our secondary specific aim is to develop and estimate a structural model that will allow us to uncover the causal pathways through which treatments effect outcomes. 8 years from randomization of CALM-PD study
Trial Locations
- Locations (1)
University of Rochester
🇺🇸Rochester, New York, United States