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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Pramipexole

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