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.)
Sponsor:
Collaborators:
Pharmacia Corp. (Peapack, NJ)
Boehringer Ingelheim
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00804479
First received: December 4, 2008
Last updated: December 5, 2008
Last verified: December 2008
  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: Observational Model: Cohort
Time Perspective: 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:


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 ]

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
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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
Sponsors and Collaborators
University of Rochester
Pharmacia Corp. (Peapack, NJ)
Boehringer Ingelheim
  More Information

No publications provided by University of Rochester

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

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Pramipexol
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antioxidants
Protective Agents
Dopamine Agonists

ClinicalTrials.gov processed this record on July 24, 2014