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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

Page last updated: August 23, 2015

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