Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: pramipexole
Intervention MeSH terms: Pramipexole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 535.0
Sex: All
Minimum age: 30 Years
Maximum age: 79 Years
Healthy volunteers: No

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