Clinical trial NCT00406029 (phase 2, status: completed)
Conditions: parkinson disease, movement disorders, central nervous system diseases, neurodegenerative diseases, brain diseases
ICD codes: G20, G47.61, G25.70, G25.9, H51.9, F98.4, G25.79, G25.89, G37.9, G37.3, G13.1, G09, G13.8, G37.8, G46.8, G94
Drugs: preladenant, preladenant, preladenant, preladenant, placebo, l-dopa, other parkinson's disease treatments
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, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, C[C@@](CC1=CC(O)=C(O)C=C1)(NN)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be 30 years of age, of either sex and of any race, with a diagnosis
             of moderate to severe idiopathic Parkinson's disease for at least 5 years.

          -  Women of childbearing potential must have a negative serum pregnancy test at Visit 2
             (Week -1). If participant is postmenopausal (not surgically induced), she must be
             postmenopausal by history for at least 2 years before study entry. If not, proper
             birth control must be used.

        Note: Acceptable methods of birth control include oral or injectable hormonal
        contraceptive, medically prescribed intrauterine device (IUD), and double-barrier method
        (eg, condom in combination with spermicide). Bilateral tubal ligation is an acceptable
        method of birth control for this study.

          -  Participants' clinical laboratory tests (complete blood count [CBC], blood
             chemistries, and urinalysis) must be within normal limits or clinically acceptable to
             the investigator/sponsor.

        Exclusion Criteria:

          -  Participants with any form of drug-induced or atypical parkinsonism, cognitive
             impairment (Mini-Mental State Examination [MMSE] score <=23), a history of Diagnostic
             and Statistical Manual of Mental Disorders IV (DSM IV) diagnosed major depression,
             unstable mild depression or psychosis, or participants taking tolcapone will be
             excluded. (Participants with mild depression who are well controlled on a stable dose
             of an antidepressant medication for at least 4 weeks before screening will be
             eligible.)

          -  All participants with a severe or ongoing unstable medical condition will be excluded
             including those with a history of poorly controlled diabetes, obesity associated with
             metabolic syndrome, uncontrolled hypertension, cerebrovascular disease, or any form of
             clinically significant cardiac disease, symptomatic orthostatic hypotension, renal
             failure, history of abnormal renal function, seizures, alcohol/drug dependence, or
             previous surgery for Parkinson's disease.

          -  Average daily consumption of more than two 4-oz (120 mL) glasses of wine or their
             equivalent.

          -  Because it is not known whether preladenant passes into breast milk and because the
             effects, if any, of preladenant on the developing human are unknown, women who are
             breastfeeding or who are considering breastfeeding are excluded from this trial.

          -  Participants with allergy/sensitivity to study drug or its excipients.

          -  Participants with any clinically significant condition or situation, other than the
             condition being studied that, in the opinion of the investigator, would interfere with
             the study evaluations or optimal participation in the study.

          -  Participants who have used any other investigational drugs within 30 days of
             Screening.

          -  Participants who are participating in any other clinical study.