Study Stopped
Funding for the CALM-PD Cohort Study was terminated by sponsor.
The Long Term Impact of Initiating Pramipexole Versus Levodopa in Early Parkinson's Disease (CALM-PD Cohort Study)
CALM-PD Cohort
Unblinded, Multicenter, Prospective Follow-up of Long-term Consequences of Initiating Patients With Parkinson's Disease on Either Pramipexole or Levodopa.
2 other identifiers
observational
222
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2002
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 4, 2008
CompletedFirst Posted
Study publicly available on registry
December 8, 2008
CompletedJanuary 21, 2016
January 1, 2016
2.2 years
December 4, 2008
January 20, 2016
Conditions
Outcome Measures
Primary Outcomes (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.
8 years from date randomized in CALM study
Secondary Outcomes (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.
8 years from randomization of CALM-PD study
Study Arms (1)
no treatment
Available 301 subjects enrolled in CALM-PD Available 82 subjects enrolled in CALM-PD imaging substudy
Interventions
Eligibility Criteria
Available 301 subjects enrolled in CALM-PD
You may qualify if:
- Available 301 subjects enrolled in the CALM-PD study.
You may not qualify if:
- Those not enrolled in the CALM-PD study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Rochesterlead
- Pharmacia Corp. (Peapack, NJ)collaborator
- Boehringer Ingelheimcollaborator
Study Sites (1)
University of Rochester
Rochester, New York, 14620, United States
Related Publications (1)
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.
PMID: 19433655DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 4, 2008
First Posted
December 8, 2008
Study Start
January 1, 2002
Primary Completion
March 1, 2004
Study Completion
March 1, 2004
Last Updated
January 21, 2016
Record last verified: 2016-01