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

Boehringer Ingelheim

Status and phase

Completed

Phase 4

Conditions

Parkinson Disease

Treatments

Drug: pramipexole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00321854

248.595

Details and patient eligibility

About

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

Enrollment

535 patients

Sex

All

Ages

30 to 79 years old

Volunteers

No 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;
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