Clinical trial NCT01294800 (phase 2, status: completed)
Conditions: parkinson's disease
ICD codes: G20
Drugs: preladenant, placebo tablet to match preladenant
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:

          -  Must have a diagnosis of idiopathic PD based on the United Kingdom Parkinson's Disease
             Society Brain Bank Criteria, judged to be moderate to severe

          -  Must have received prior therapy with L-dopa for more than 1 year before Screening

          -  Must have been on a stable, optimal dopaminergic treatment regimen, defined as maximum

        therapeutic effect achieved with available anti-Parkinsonian treatment, for at least the 4
        weeks immediately before randomization

          -  If receiving one or more of the following adjunctive treatments: amantadine,
             anticholinergics, catechol-O-methyltransferase inhibitors, dopa decarboxylase
             inhibitors, dopamine agonists, entacapone, L-dopa, must have been on a stable regimen
             of treatment for at least the 4 weeks immediately before randomization

          -  Hoehn and Yahr stage must be ≥ 2.5 and ≤ 4 following optimum titration of treatment
             medications at Screening

          -  Must be experiencing motor fluctuations with or without dyskinesias following optimum
             titration of

        treatment medications and within the 4 weeks immediately before Screening

        - Must be experiencing a minimum of 2 hours/day of "off" time as estimated by the
        investigator

        and supported by the symptom diary (Daily Diary) at the Diary Training Visit

        - With or without the help of a caregiver, must be capable of maintaining an accurate and

        complete symptom diary (Daily Diary) as assessed at the Diary Training Visit

        - Must have results of Screening clinical laboratory tests (complete blood count [CBC],
        blood

        chemistries, and urinalysis) within normal limits or clinically acceptable to the
        investigator at Screening

        - Must have results of a physical examination within normal limits or clinically acceptable
        limits

        to the investigator

          -  Must be able to adhere to dose and visit schedules

          -  Females of child-bearing potential must have a negative serum pregnancy test (human
             chorionic

        gonadotropin [hCG]) at Screening and must agree to use a medically accepted method of
        contraception while receiving protocol-specified medication and for 2 weeks after stopping
        the medication

        Exclusion Criteria:

          -  Must not have a form of drug-induced or atypical parkinsonism, cognitive impairment,
             bipolar disorder, schizophrenia, or other psychotic disorder

          -  Must not have had surgery for PD

          -  Must not have an untreated major depressive disorder meeting Diagnostic and
             Statistical Manual

        of Mental Disorders IV Text Revision (DSM-IV-TR) criteria

        - Must not be at imminent risk of self-harm or harm to others, in the investigator's
        opinion based on

        clinical interview

          -  Must not have participated in any studies using preladenant

          -  Must not have allergy/sensitivity to preladenant or any of its excipients

          -  Must not have used any investigational drugs or participated in any other clinical
             trial within 90 days of Screening