Please select the eligibility criteria that correspond to the clinical trial below.
Title: 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.
Brief 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


Options:
A: Inclusion Criteria:

* Idiopathic PD treated with levodopa and experiencing motor fluctuations
* At least 21 years of age
* Male or female.

Exclusion Criteria:

* Cardiovascular disease, psychosis, extreme anxiety, dementia and other unstable medical conditions.
B: Inclusion Criteria:

* Men and women with idiopathic PD whose diagnosis is confirmed at screening, with at least two cardinal signs without any other known or suspected cause of parkinsonism. If tremor is not present, subjects must have unilateral onset and persistent asymmetry.
* Subjects with a diagnosis of early idiopathic PD of less than 1½ years duration from time of documented diagnosis.
* Subjects whose clinical condition at the time of enrollment does not require anti-PD treatment and will not require for the next 9 months.
* Willing and able to give informed consent.

Exclusion Criteria:

* Subjects younger than 30 or older than 80 years.
* Subjects with loss of postural reflexes.
* Subjects with UPDRS Tremor score of 3 or greater in any limb.
* Subjects with Hoehn \&Yahr Stage III or greater at screening.
* Subjects with freezing while walking.
* Subjects with any of the following features that tend to exclude PD as the cause of Parkinsonism:
* History of repeated strokes with stepwise progression of Parkinsonian features
* History of repeated head injury or history of definite encephalitis
* Sustained remission
* Supranuclear gaze palsy
* Cerebellar signs
* Early severe autonomic involvement
* Babinski's sign
* Presence of a cerebral tumour or communicating hydrocephalus
* MPTP exposure
* Oculogyric crises
* Subjects who have had previous use of rasagiline or selegiline
* Subjects having used other anti-PD medication basis at any time prior to baseline
* Subjects having used other anti-PD medication (including anticholinergics) for less than 3 weeks during the 3 month period prior to baseline. (not including a single L-Dopa dose as part of L-Dopa test)
* Subjects having used any other anti-PD medication (including anticholinergics) for less than 3 weeks prior to the 3 month period preceding baseline whose anti-PD medication is intentionally ceased in order for the subject to enter the study.
* Subjects who have a clinically significant or unstable medical or surgical condition that may preclude safe and complete participation
* Hypertensive subjects whose BP is not well controlled according to the medical record or as observed during the week of home BP recording prior to baseline
* Subjects diagnosed with melanoma based on the screening dermatologic examination, or with a history of melanoma. Subjects with suspicious lesions at baseline who do not undergo biopsy
* Subjects with significant cognitive impairment as defined by MMSE score \< 26
* Subjects with clinically significant psychiatric illness, including major depression \[Beck Depression Inventory (short form) ≥15
* Subjects with a history of alcohol or substance abuse within the past 2 years
* Subjects who have taken any experimental medications within 60 days prior to baseline
* Subjects who have used coenzyme Q10 (in daily doses \> 300 mg) within 120 days prior to baseline
* Subjects who have used sympathomimetics (including over-the-counter remedies - nasal or oral), dextromethorphan, pethidine or St. John's Wort within the 7 days prior to baseline
* Subjects who have used antidepressants within 42 days prior to baseline
* Subjects who have used ciprofloxacin, a potent CYP 1A2 inhibitor within 7 days prior to baseline
* Subjects who have used MAO inhibitors including reserpine or methyldopa within the three months prior to baseline, or treatment with an anti-emetic or antipsychotic medication with central dopamine antagonist activity within the six months prior to baseline
* Women who are not postmenopausal, surgically sterilized, or using adequate birth control \[oral birth control pills, IUD, or a long acting injectable form of contraception; barrier methods alone (i.e., condom) are not sufficient\]. Women of childbearing potential without a negative pregnancy test at screening. Nursing women
C: Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's Disease,
* Early stage of disease, Modified Hoehn \& Yahr up to stage III,
* UPDRS motor score (part III) 10 at baseline.

Exclusion Criteria:

* Diagnosis is unclear or a suspicion of other parkinsonian syndromes,
* Patients who have undergone surgery for the treatment of PD,
* Presence of dyskinesias,
* Motor fluctuations or loss of postural reflexes,
* Clinically significant abnormalities,
* Patients treated with L-dopa or dopamine agonists currently or in the past (for more than 3 months in total),
* Antipsychotic.
D: 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

Answer: D