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
- PHASE4
- INTERVENTIONAL
Last updated: 2014-05-16
Purpose of Trial
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
This study is for people with
Parkinson Disease
Interventions being studied
pramipexole
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;
* 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
ELIGIBILITY
Gender: ALL
Age: 30+
Healthy Volunteers: No
32 Locations
Brimingham
248.595.0122 Boehringer Ingelheim Investigational Site
Alabama, United States
Scottsdale
248.595.0104 Boehringer Ingelheim Investigational Site
Arizona, United States
La Jolla
248.595.0133 Boehringer Ingelheim Investigational Site
California, United States
La Jolla
248.595.0140 Boehringer Ingelheim Investigational Site
California, United States
New Haven
248.595.0112 Boehringer Ingelheim Investigational Site
Connecticut, United States
Bradenton
248.595.0113 Boehringer Ingelheim Investigational Site
Florida, United States
Gainesville
248.595.0105 Boehringer Ingelheim Investigational Site
Florida, United States
Hollywood
248.595.0119 Boehringer Ingelheim Investigational Site
Florida, United States
Palm Beach Gardens
248.595.0124 Boehringer Ingelheim Investigational Site
Florida, United States
Panama City
248.595.0123 Boehringer Ingelheim Investigational Site
Florida, United States
South Miami
248.595.0109 Boehringer Ingelheim Investigational Site
Florida, United States
St. Petersburg
248.595.0115 Boehringer Ingelheim Investigational Site
Florida, United States
Tampa
248.595.0106 Boehringer Ingelheim Investigational Site
Florida, United States
Atlanta
248.595.0103 Boehringer Ingelheim Investigational Site
Georgia, United States
Augusta
248.595.0127 Boehringer Ingelheim Investigational Site
Georgia, United States
Columbus
248.595.0137 Boehringer Ingelheim Investigational Site
Georgia, United States
Chicago
248.595.0101 Boehringer Ingelheim Investigational Site
Illinois, United States
Elk Grove Village
248.595.0111 Boehringer Ingelheim Investigational Site
Illinois, United States
Scarbourough
248.595.0131 Boehringer Ingelheim Investigational Site
Maine, United States
Baltimore
248.595.0134 Boehringer Ingelheim Investigational Site
Maryland, United States
Worcester
248.595.0141 Boehringer Ingelheim Investigational Site
Massachusetts, United States
Traverse City
248.595.0102 Boehringer Ingelheim Investigational Site
Michigan, United States
New York
248.595.0129 Boehringer Ingelheim Investigational Site
New York, United States
Raleigh
248.595.0139 Boehringer Ingelheim Investigational Site
North Carolina, United States
Winston Salem
248.595.0136 Boehringer Ingelheim Investigational Site
North Carolina, United States
Cleveland
248.595.0120 Boehringer Ingelheim Investigational Site
Ohio, United States
Dayton
248.595.0107 Boehringer Ingelheim Investigational Site
Ohio, United States
Tulsa
248.595.0118 Boehringer Ingelheim Investigational Site
Oklahoma, United States
Warwick
248.595.0114 Boehringer Ingelheim Investigational Site
Rhode Island, United States
Memphis
248.595.0116 Boehringer Ingelheim Investigational Site
Tennessee, United States
Houston
248.595.0108 Boehringer Ingelheim Investigational Site
Texas, United States
Kirkland
248.595.0121 Boehringer Ingelheim Investigational Site
Washington, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov