The Long Term Impact of Initiating Pramipexole Versus Levodopa in Early Parkinson's Disease (CALM-PD Cohort Study) (CALM-PD Cohort)

January 20, 2016 updated by: Robert Holloway, University of Rochester

Unblinded, Multicenter, Prospective Follow-up of Long-term Consequences of Initiating Patients With Parkinson's Disease on Either Pramipexole or Levodopa.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

222

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14620
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Available 301 subjects enrolled in CALM-PD

Description

Inclusion Criteria:

  • Available 301 subjects enrolled in the CALM-PD study.

Exclusion Criteria:

  • Those not enrolled in the CALM-PD study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
no treatment
Available 301 subjects enrolled in CALM-PD Available 82 subjects enrolled in CALM-PD imaging substudy
Other: No intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 8 years from date randomized in CALM study
8 years from date randomized in CALM study

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 8 years from randomization of CALM-PD study
8 years from randomization of CALM-PD study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

Boehringer Ingelheim
Pharmacia Corp. (Peapack, NJ)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

March 1, 2004

Study Completion (Actual)

March 1, 2004

Study Registration Dates

First Submitted

December 4, 2008

First Submitted That Met QC Criteria

December 5, 2008

First Posted (Estimate)

December 8, 2008

Study Record Updates

Last Update Posted (Estimate)

January 21, 2016

Last Update Submitted That Met QC Criteria

January 20, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPXAPD-0072-138
  • RSRB #09283

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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