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

This study has been terminated.

( Funding for the CALM-PD Cohort Study was terminated by sponsor. )

First Received: December 4, 2008 Last Updated: December 5, 2008 History of Changes

Sponsor:	University of Rochester
Collaborators:	Pharmacia Corp. (Peapack, NJ) Boehringer Ingelheim Pharmaceuticals
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00804479

Purpose

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.

Condition	Intervention
Parkinson's Disease	Other: No intervention.

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Unblinded, Multicenter, Prospective Follow-up of Long-Term Consequences of Initiating Patients With Parkinson's Disease on Either Pramipexole or Levodopa.

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Pramipexol Pramipexole dihydrochloride

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	222
Study Start Date:	January 2002
Study Completion Date:	March 2004
Primary Completion Date:	March 2004 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
no treatment Available 301 subjects enrolled in CALM-PD Available 82 subjects enrolled in CALM-PD imaging substudy	Other: No intervention.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Available 301 subjects enrolled in CALM-PD

Criteria

Inclusion Criteria:

Available 301 subjects enrolled in the CALM-PD study.

Exclusion Criteria:

Those not enrolled in the CALM-PD study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804479

Locations

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

Sponsors and Collaborators

University of Rochester

Pharmacia Corp. (Peapack, NJ)

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided by University of Rochester

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	University of Rochester ( Robert Holloway, MD, MPH )
Study ID Numbers:	PPXAPD-0072-138, RSRB #09283
Study First Received:	December 4, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00804479 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Antiparkinson Agents
Central Nervous System Diseases
Dopamine Agonists
Brain Diseases

Neurodegenerative Diseases
Protective Agents
Pramipexol
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010