| Criteria: |
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Inclusion Criteria:
- Subjects with a diagnosis of idiopathic PD for < 5 years will be selected.
- Each subject who is receiving amantadine and/or anticholinergics must have been on a
stable regimen of treatment for at least the 4 weeks immediately before Screening.
(Note: Subjects who are not taking any medications for PD are permitted to enroll in
this trial.)
- Each subject must have a UPDRS Part 3 score of >= 10, a Hoehn and Yahr Stage <= 3, be
>= 30 to <= 85 years of age, and have results of Screening clinical laboratory tests
drawn within 3 weeks prior to Randomization, clinically acceptable to the
investigator, and not within the parameters specified for exclusion (below).
- Each subject is either a male or
1. A female of reproductive potential who agrees or use a highly effective method
of birth control during the study; or
2. A female patient who is not of reproductive potential (ie, reached natural
menopause, 6 weeks post-surgical bilateral oophorectomy, hysterectomy, or
bilateral tubal ligation).
Exclusion Criteria:
- A subject must not have a form of drug induced or atypical parkinsonism, cognitive
impairment, bipolar disorder, untreated major depressive disorder, schizophrenia, or
other psychotic disorder; history of exposure to a known neurotoxin, or any
neurological features not consistent with the diagnosis of PD as assessed by the
investigator.
- A subject must not have a history of repeated strokes or head injuries, or a stroke
within 6 months of Screening; poorly controlled diabetes; abnormal renal function; or
a severe or ongoing unstable medical condition.
- A subject must not have failed to show a therapeutic response if a diagnostic
levodopa (L dopa) challenge had been done with a large test dose ( > 500 mg) of L
dopa (if malabsorption excluded).
- A subject must not have been treated with L dopa or dopamine agonists for other than
diagnostic purposes (within 30 days before Screening).
- A subject must not be at imminent risk of self-harm or harm to others.
- A subject must not have a systolic blood pressure (BP) >= 150 mm Hg OR diastolic BP
>= 100 mm Hg at Screening and at a BP recheck prior to study start.
- A subject must not have had any clinically significant cardiovascular event or
procedure for 6 months prior to Randomization, including, but not limited to,
myocardial infarction, angioplasty, unstable angina, or heart failure; and a subject
must not have heart failure staged New York Heart Association Class III or IV.
- A subject must not have an alanine aminotransferase (ALT) or aspartate amino
transferase (AST) > 3 x the upper limit of normal (ULN) or total bilirubin (T BIL) >
1.5 x ULN.
- A subject must not have a history of serologically confirmed hepatic dysfunction
(defined as viral infection [Hepatitis B or C; Epstein Barr virus {EBV};
cytomegalovirus {CMV}]) or a history of diagnosis of drug or alcohol induced hepatic
toxicity or frank hepatitis.
- A subject must not have a history within the past 5 years of a primary or recurrent
malignant disease with the exception of adequately treated basal cell or squamous
cell skin cancer, in situ cervical cancer, or in situ prostate cancer with a normal
prostate-specific antigen (PSA) post resection.
- A subject must not have received certain prespecified medications or ingested high
tyramine-containing aged cheeses (eg, Stilton) for a prespecified time window before
the trial, during the trial, and for 2 weeks after the trial.
- A subject must not have an average daily consumption of more than three 4 ounce
glasses (180 mL) of wine or the equivalent.
- A subject must not have a severe or ongoing unstable medical condition (eg, any form
of clinically significant cardiac disease, symptomatic orthostatic hypotension,
seizures, or alcohol/drug dependence).
- A subject must not have allergy/sensitivity to investigational product(s) or
its/their excipients.
- A female subject must not be breast-feeding, considering breast-feeding, pregnant or
intending to become pregnant.
- A subject must not have used preladenant ever, or any investigational drugs within 90
days immediately before Screening. |