Clinical trial NCT01155479 (phase 3, status: terminated)
Conditions: parkinson disease
ICD codes: G20
Drugs: preladenant 2 mg tablet, preladenant 5 mg tablet, preladenant 10 mg tablet, rasagiline 1 mg capsule, placebo for rasagiline 1 mg capsule, placebo for preladenant
SMILES: COCCOC1=CC=C(C=C1)N1CCN(CCN2N=CC3=C2N=C(N)N2N=C(N=C32)C2=CC=CO2)CC1, COCCOC1=CC=C(C=C1)N1CCN(CCN2N=CC3=C2N=C(N)N2N=C(N=C32)C2=CC=CO2)CC1, COCCOC1=CC=C(C=C1)N1CCN(CCN2N=CC3=C2N=C(N)N2N=C(N=C32)C2=CC=CO2)CC1, C#CCN[C@@H]1CCC2=CC=CC=C12, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    termininated for business reasons
  
Eligibility criteria:

        Inclusion Criteria:

          -  Has a diagnosis of idiopathic PD for < 5 years.

          -  If receiving amantadine and/or anticholinergics, must have been on a stable regimen of
             treatment for at least the 5 weeks immediately before Screening. (Note: Participants
             who are not taking any medications for PD are permitted to enroll in this trial.)

          -  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 5 weeks
             prior to randomization, clinically acceptable to the investigator, and not within the
             parameters specified for exclusion.

          -  If sexually active or plan to be sexually active, must agree to use a highly effective
             method of birth control while the participant is in the study and for 2 weeks after
             the last dose of study drug. A male participant must also not donate sperm during the
             trial and within 2 weeks after the last dose of study drug.

        Exclusion Criteria:

          -  Must not have a form of drug-induced or atypical Parkinsonism, cognitive impairment
             (ie, Montreal Cognitive Assessment [MoCA] score <22), 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.

          -  Must not have had surgery for PD.

          -  Must not have a history of repeated strokes with stepwise progression of Parkinsonism
             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.

          -  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), or failed to respond to an adequate previous treatment with dopaminergic
             therapy.

          -  Must not have been treated with L dopa or dopamine agonists for 30 days or more. A
             participant who has been treated with L-dopa or dopamine agonists for <30 days will be
             allowed to enter the study. These participants must stop taking dopaminergic
             medication 30 days prior to Randomization.

          -  Must not be at imminent risk of self-harm or harm to others.

          -  Must not have elevated blood pressure (BP) (systolic BP ≥150 mm Hg or diastolic BP ≥95
             mm Hg) that cannot be adequately controlled with antihypertensive medication, as
             demonstrated by 2 BP measurements meeting acceptable BP criterion at consecutive
             scheduled or unscheduled visits between Screening and Randomization (a 5-6 week
             period), one of which must be the Randomization visit.

          -  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 participant must not have heart
             failure staged New York Heart Association Class III or IV.

          -  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.

          -  Must not have active serologically-confirmed hepatic dysfunction (defined as viral
             infection [Hepatitis B, C, or E; Epstein-Barr virus (EBV)]; cytomegalovirus [CMV] or a
             history of diagnosis of drug- or alcohol-induced hepatic toxicity or frank hepatitis,
             or a history of diagnosis of drug- or alcohol-induced hepatic toxicity or frank
             hepatitis.)

          -  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.

          -  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.

          -  Must not have an average daily consumption of more than three 4 ounce glasses (118 mL)
             of wine or the equivalent.

          -  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.)

          -  Must not have allergy/sensitivity to investigational product(s) or its/their
             excipients.

          -  Must not be breast-feeding, considering breast-feeding, pregnant or intending to
             become pregnant.

          -  Must not have used preladenant ever, or any investigational drugs within 90 days
             immediately before screening.