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

NCT ID: NCT00804479

Last Updated: 2016-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

222 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-01-31

Study Completion Date

2004-03-31

Brief Summary

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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

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Conditions

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Parkinson's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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no treatment

Available 301 subjects enrolled in CALM-PD Available 82 subjects enrolled in CALM-PD imaging substudy

No intervention.

Intervention Type OTHER

Interventions

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No intervention.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Those not enrolled in the CALM-PD study.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmacia Corp. (Peapack, NJ)

UNKNOWN

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Robert Holloway

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

References

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Parkinson Study Group CALM Cohort Investigators. Long-term effect of initiating pramipexole vs levodopa in early Parkinson disease. Arch Neurol. 2009 May;66(5):563-70. doi: 10.1001/archneur.66.1.nct90001.

Reference Type DERIVED
PMID: 19433655 (View on PubMed)

Other Identifiers

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RSRB #09283

Identifier Type: -

Identifier Source: secondary_id

PPXAPD-0072-138

Identifier Type: -

Identifier Source: org_study_id

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