Clinical trial NCT01227265 (phase 3, status: completed)
Conditions: parkinson disease, idiopathic parkinson disease, idiopathic parkinson's disease
ICD codes: G20, E20.0, I95.0, L50.1, D61.3, G24.2, G24.4, G60.3, G20
Drugs: preladenant, placebo
SMILES: COCCOC1=CC=C(C=C1)N1CCN(CCN2N=CC3=C2N=C(N)N2N=C(N=C32)C2=CC=CO2)CC1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Each participant must have a diagnosis of idiopathic Parkinson's disease.

          -  Each participant 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.

          -  Each participant 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 agonist, anticholinergics) are permitted to enroll
             in this trial. Participants taking only L-dopa are permitted to enroll in this trial.

          -  Each participant 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.

          -  Each participant, with or without the help of a caregiver, must be capable of
             maintaining an accurate and complete symptom diary and to adhere to dose and visit
             schedules.

          -  Each participant must 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 (below).

          -  All participants who are 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. A male participant must also not donate sperm within 2 weeks
             after the last dose of study drug.

        Exclusion Criteria:

          -  A participant 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 exposure to a known neurotoxin, or
             any neurological features not consistent with the diagnosis of PD as assessed by the
             investigator.

          -  A participant 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 participant must not have had surgery for their PD.

          -  A participant must not be at imminent risk of self-harm or harm to others.

          -  A participant must not have a systolic blood pressure (BP) ≥150 mm Hg OR diastolic BP
             ≥95 mm Hg at Screening and at 2 BP rechecks prior to study start.

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

          -  A participant must not have an alanine aminotransferase (ALT) or aspartate
             aminotransferase (AST) ≥3 x the upper limit of normal (ULN) or total bilirubin (T BIL)
             ≥1.5 x ULN.

          -  A participant must not have a history of 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.

          -  A participant 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 participant must not have received certain prespecified medications for a
             prespecified time window before the trial.

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

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

          -  A participant must not be breast-feeding, considering breast-feeding, pregnant, or
             intending to become pregnant.

          -  A participant must not have used preladenant ever, or any investigational drugs within
             90 days immediately before Screening.