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Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)

A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Examine the Efficacy and Safety of Early Pramipexole (PPX) Treatment Versus Delayed Pramipexole Treatment in Patients With New Onset Parkinson's Disease.

NCT00321854•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

This is a double blind, placebo-controlled clinical trial of 15 months duration designed to examine early Mirapex (pramipexole) treatment vs. delayed Mirapex (pramipexole) treatment in patients with new onset Parkinsons disease

Eligibility

Age

30 - 79 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation;
•Male or female patient with idiopathic Parkinson Disease (PD) confirmed by at least three of the following signs: resting tremor, bradykinesia, rigidity, and asymmetry (must have bradykinesia);
•Parkinsons disease newly diagnosed within the past 2 years;
•Patients with idiopathic PD characterized as Stage I-II by the Modified Hoehn and Yahr Scale who do not require PD medication and will not likely need PD medication for at least 6 months in the opinion of the investigator; Age 30 to 75 years at screening (Visit 1);
•Women of childbearing potential must have a negative serum Beta-HumanChorionGonadotropin (Beta-HCG) pregnancy test at the Screening (Baseline) visit unless surgically sterile or post-menopausal (last menstruation 12 months prior to signing Informed Consent). Women of childbearing potential must be using a medically accepted contraceptive method. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable, or injectable contraceptives, estrogen patch, and double barrier method (spermicide + diaphragm); and Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria

•Previous history of allergic response or complications with pramipexole (PPX) or its excipients;
•Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine) or metabolic disorders (e.g., Wilsons Disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy);
•The patient is currently on L-dopa, dopamine agonists or other PD medication at baseline;
•The patient has been on L-dopa, dopamine agonists or other PD medications for greater than 14 consecutive days prior to baseline;
•If on L-dopa, dopamine agonists or other PD medications prior to baseline, the patient stopped treatment less than 30 days prior to baseline;
•The patient has clinically significant abnormal laboratory values, and/or medical or psychiatric illness other than as seen in Parkinsons disease;
•The patient has a clinically significant deviation from normal in the physical examination other than as seen in Parkinsons disease;
•The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery);
•History of stereotactic brain surgery;
•Surgery within 6 months of randomization, which in the opinion of the investigator, would negatively impact the patients participation in the study;
+9 more criteria

Locations (99)

248.595.0122 Boehringer Ingelheim Investigational Site

Brimingham, Alabama, United States

248.595.0104 Boehringer Ingelheim Investigational Site

Scottsdale, Arizona, United States

248.595.0133 Boehringer Ingelheim Investigational Site

La Jolla, California, United States

248.595.0140 Boehringer Ingelheim Investigational Site

La Jolla, California, United States

248.595.0112 Boehringer Ingelheim Investigational Site

New Haven, Connecticut, United States

248.595.0113 Boehringer Ingelheim Investigational Site

Bradenton, Florida, United States

248.595.0105 Boehringer Ingelheim Investigational Site

Gainesville, Florida, United States

248.595.0119 Boehringer Ingelheim Investigational Site

Hollywood, Florida, United States

248.595.0124 Boehringer Ingelheim Investigational Site

Palm Beach Gardens, Florida, United States

248.595.0123 Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

Key Dates

Start Date

May 1, 2006

Primary Completion Date

April 1, 2009

Last Updated

May 16, 2014

Enrollment

535

ACTUAL participants

Conditions

Parkinson Disease

Interventions

pramipexole

DRUG

[18F]F-DOPA Imaging in Patients With Autonomic Failure

NCT04246437

Autonomic FailurePure Autonomic Failure+3 more

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RECRUITINGNA

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations