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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)

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ClinicalTrials.gov Identifier: NCT00804479
Recruitment Status : Terminated (Funding for the CALM-PD Cohort Study was terminated by sponsor.)
First Posted : December 8, 2008
Last Update Posted : January 21, 2016
Sponsor:
Collaborators:
Pharmacia Corp. (Peapack, NJ)
Boehringer Ingelheim
Information provided by (Responsible Party):
Robert Holloway, University of Rochester

Brief Summary:
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 or disease Intervention/treatment
Parkinson's Disease Other: No intervention.

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Study Type : Observational
Actual Enrollment : 222 participants
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.
Study Start Date : January 2002
Actual Primary Completion Date : March 2004
Actual Study Completion Date : March 2004

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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 :
  1. 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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
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.

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
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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 Posted: December 8, 2008    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
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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