The Long Term Impact of Initiating Pramipexole Versus Levodopa in Early Parkinson's Disease (CALM-PD Cohort Study)
Information source: University of Rochester
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease
Intervention: No intervention. (Other)
Phase: N/A
Status: Terminated
Sponsored by: University of Rochester
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.
Clinical Details
Official title: Unblinded, Multicenter, Prospective Follow-up of Long-Term Consequences of Initiating Patients With Parkinson's Disease on Either Pramipexole or Levodopa.
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: 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.
Secondary outcome: 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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Available 301 subjects enrolled in the CALM-PD study.
Exclusion Criteria:
- Those not enrolled in the CALM-PD study.
Locations and Contacts
University of Rochester, Rochester, New York 14620, United States
Additional Information
Starting date: January 2002
Last updated: December 5, 2008
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