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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00804479

Acronym

CALM-PD Cohort

Enrollment

222

Registered

2008-12-08

Start date

2002-01-31

Completion date

2004-03-31

Last updated

2016-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

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.

Interventions

OTHERNo intervention.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Those not enrolled in the CALM-PD study.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026