study of (mirapex) pramipexole for the early treatment of parkinsons disease (pd)

Conditions: Parkinson Disease

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 criteria:
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