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

This study has been terminated.
(Funding for the CALM-PD Cohort Study was terminated by sponsor.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00804479
First Posted: December 8, 2008
Last Update Posted: January 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Pharmacia Corp. (Peapack, NJ)
Boehringer Ingelheim
Information provided by (Responsible Party):
Robert Holloway, University of Rochester
  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 Robert Holloway, 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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Holloway, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00804479     History of Changes
Other Study ID Numbers: PPXAPD-0072-138
RSRB #09283
First Submitted: December 4, 2008
First Posted: December 8, 2008
Last Update Posted: January 21, 2016
Last Verified: January 2016

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
Pramipexole
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antioxidants
Protective Agents
Dopamine Agonists