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

Parkinson's Disease Clinical Trial

— CALM-PD Cohort  

Official title:

Unblinded, Multicenter, Prospective Follow-up of Long-term Consequences of Initiating Patients With Parkinson's Disease on Either Pramipexole or Levodopa.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00804479
• Other study ID #: PPXAPD-0072-138
• Secondary ID: RSRB #09283
• Status: Terminated
• Phase: N/A
• First received: December 4, 2008
• Last updated: January 20, 2016
• Start date: January 2002
• Est. completion date: March 2004

Study information

• Verified date: January 2016
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 222
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Available 301 subjects enrolled in the CALM-PD study.

Exclusion Criteria:

• Those not enrolled in the CALM-PD study.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• No intervention.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (3)

Lead Sponsor	Collaborator
University of Rochester	Boehringer Ingelheim, Pharmacia Corp. (Peapack, NJ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No