## Protocol Section
### Identification Module
**NCT ID:** NCT00804479

**Acronym:** CALM-PD Cohort

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

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

#### Organization Study ID Info
**ID:** PPXAPD-0072-138
#### Organization
**Class:** OTHER
**Full Name:** University of Rochester
#### Secondary ID Infos
**ID:** RSRB #09283
### Status Module
#### Completion Date
**Date:** 2004-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-01-21

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-01-20

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2004-03

**Type:** ACTUAL

#### Start Date
**Date:** 2002-01

**Status Verified Date:** 2016-01

#### Study First Post Date
**Date:** 2008-12-08
**Type:** ESTIMATED
**Study First Submit Date:** 2008-12-04
**Study First Submit QC Date:** 2008-12-05
**Why Stopped:** Funding for the CALM-PD Cohort Study was terminated by sponsor.
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Pharmacia Corp. (Peapack, NJ)

**Class:** INDUSTRY

**Name:** Boehringer Ingelheim

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Rochester

#### Responsible Party

**Investigator Affiliation:** University of Rochester

**Investigator Full Name:** Robert Holloway

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Parkinson's Disease

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 222

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Available 301 subjects enrolled in CALM-PD Available 82 subjects enrolled in CALM-PD imaging substudy

**Intervention Names:**

- Other: No intervention.

**Label:** no treatment

### Interventions

#### Intervention 1

**Arm Group Labels:**

- no treatment

**Name:** No intervention.

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** 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 Outcomes

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

* Those not enrolled in the CALM-PD study.

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Available 301 subjects enrolled in CALM-PD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Rochester

**Country:** United States

**Facility:** University of Rochester

**State:** New York

**Zip:** 14620

### References Module

#### References

**Citation:** 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:** 19433655

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020734

- Term: Parkinsonian Disorders

- ID: D000001480

- Term: Basal Ganglia Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009069

- Term: Movement Disorders

- ID: D000080874

- Term: Synucleinopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M13213

- Name: Parkinson Disease

- Relevance: HIGH

- As Found: Parkinson's Disease

- ID: M22494

- Name: Parkinsonian Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M25603

- Name: Ganglion Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M16358

- Name: Synovial Cyst

- Relevance: LOW

- As Found: Unknown

- ID: M4774

- Name: Basal Ganglia Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12029

- Name: Movement Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M2217

- Name: Synucleinopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010300

- Term: Parkinson Disease

### Intervention Browse Module - Browse Branches

- Abbrev: AnDyAg

- Name: Anti-Dyskinesia Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1813

- Name: Pramipexole

- Relevance: LOW

- As Found: Unknown

- ID: M3373

- Name: Dexpramipexole

- Relevance: LOW

- As Found: Unknown

- ID: M10982

- Name: Levodopa

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
