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

Completed · Phase 4

Conditions studied: Parkinson Disease

In brief

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

Key facts

Study ID

NCT00321854

Run by

Boehringer Ingelheim

People needed

535

Starts

2006-05-01

Last updated by the study team

2014-05-16

Who can join

Age: 30 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;
• History of active epilepsy (i.e., occurrence of a seizure) within the past year;
• Symptomatic orthostatic hypotension prior to randomization;
• Malignant melanoma or history of previously treated malignant melanoma;
• Patients who have received any of the following drugs (all time periods are calculated from randomization): Amantadine;
• Electroconvulsive therapy during 180 days preceding the screening visit (Visit 1);
• Patients who are currently pregnant or planning pregnancy during the study, or lactating;
• Participation in other investigational drug studies or use of other investigational drugs within the previous 30 days prior to randomization;
• History of psychosis;
• A diagnosis of dementia

Where it is running

• 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
• 248.595.0109 Boehringer Ingelheim Investigational Site — South Miami, Florida, United States
• 248.595.0115 Boehringer Ingelheim Investigational Site — St. Petersburg, Florida, United States
• 248.595.0106 Boehringer Ingelheim Investigational Site — Tampa, Florida, United States
• 248.595.0103 Boehringer Ingelheim Investigational Site — Atlanta, Georgia, United States
• 248.595.0127 Boehringer Ingelheim Investigational Site — Augusta, Georgia, United States
• 248.595.0137 Boehringer Ingelheim Investigational Site — Columbus, Georgia, United States
• 248.595.0101 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
• 248.595.0111 Boehringer Ingelheim Investigational Site — Elk Grove Village, Illinois, United States
• 248.595.0131 Boehringer Ingelheim Investigational Site — Scarbourough, Maine, United States
• 248.595.0134 Boehringer Ingelheim Investigational Site — Baltimore, Maryland, United States
• 248.595.0141 Boehringer Ingelheim Investigational Site — Worcester, Massachusetts, United States
• 248.595.0102 Boehringer Ingelheim Investigational Site — Traverse City, Michigan, United States
• 248.595.0129 Boehringer Ingelheim Investigational Site — New York, New York, United States
• 248.595.0139 Boehringer Ingelheim Investigational Site — Raleigh, North Carolina, United States
• 248.595.0136 Boehringer Ingelheim Investigational Site — Winston-Salem, North Carolina, United States
• 248.595.0122 Boehringer Ingelheim Investigational Site — Brimingham, Alabama, United States

Full record on ClinicalTrials.gov

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