Clinical trial NCT01155466 (phase 3, status: completed)
Conditions: parkinson disease
ICD codes: G20
Drugs: preladenant 2 mg tablet, preladenant 5 mg tablet, preladenant 10 mg tablet, placebo to preladenant tablet, rasagiline 1 mg capsule, placebo to rasagiline capsule
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, 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, C#CCN[C@@H]1CCC2=CC=CC=C12
Eligibility criteria:

        Inclusion Criteria:

          -  Must have a diagnosis of moderate to severe idiopathic Parkinson's disease.

          -  Must have received prior therapy with L dopa for approximately 1 or more years
             immediately before Screening and must continue to have a beneficial clinical response
             to L dopa

          -  Must have been on a stable dopaminergic treatment regimen for at least the 5 weeks
             immediately before Randomization. Participants receiving other adjunctive treatments
             (eg, dopamine agonists, anticholinergics, entacapone) or taking only L dopa are
             permitted, provided the treatment regimen has been taken for at least 5 weeks prior to
             randomization

          -  Must be experiencing motor fluctuations with or without dyskinesias within the 4 weeks
             immediately before Screening, must be experiencing a minimum of 2 hours/day of "off"
             time, and have a Hoehn & Yahr stage between 2.5 and 4 when in the "on" state

          -  Must be capable of maintaining an accurate and complete symptom diary and to adhere to
             dose and visit schedules with or without the help of a caregiver

          -  Must have results of a physical examination and screening clinical laboratory tests
             clinically acceptable to the investigator

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

        Exclusion Criteria:

          -  Must not have a form of drug induced or atypical parkinsonism, a 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

          -  Must not have a history of repeated strokes or head injuries, or a stroke within 6
             months of Screening

          -  Must not have poorly-controlled diabetes or abnormal renal function

          -  Must not have had surgery for their PD

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

          -  Must not have sleep attacks or compulsive behavior that would interfere with the
             integrity of the trial or would pose a risk to the subject in participating in the
             trial

          -  Must not have a systolic blood pressure (BP) ≥150 mm Hg OR diastolic BP ≥95 mm Hg at
             Screening

          -  Must not have had any clinically significant cardiovascular event or procedure for 6
             months prior to study start, including, but not limited to, myocardial infarction,
             angioplasty, unstable angina, or heart failure; and 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 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

          -  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

          -  A female subject 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