Dyskinesia in Parkinson's Disease (Study P04501)
Condition: Parkinson Disease; Movement Disorders; Central Nervous System Diseases; Neurodegenerative Diseases; Brain Diseases
MeSH terms: Parkinson Disease; Nervous System Diseases; Dyskinesias; Movement Disorders; Neurodegenerative Diseases; Brain Diseases; Central Nervous System Diseases
Intervention: Preladenant; Preladenant; Preladenant; Preladenant; Placebo; L-dopa; Other Parkinson's Disease treatments
Intervention description: 1 mg BID capsules; 2 mg BID capsules; 5 mg BID capsules; 10 mg BID capsules; BID capsules; Participants must receive L-dopa as part of their usual ongoing treatment for Parkinson's Disease. L-dopa is often administered concomitantly with a dopa decarboxylase inhibitor (e.g., carbidopa).; Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the catechol-O-methyl transferase (COMT) inhibitor entacapone.
Intervention MeSH terms: Levodopa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 253.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to assess the efficacy and safety of a range of doses of SCH
      420814 (preladenant) when used together with a stable dose of L-dopa/dopa decarboxylase
      inhibitor to treat Parkinson's disease. In this study, we will be comparing 3 doses (1 mg, 2
      mg, and 5 mg taken twice a day) of preladenant with placebo (sugar pill). Following an
      Interim Analysis (temporary hold for new enrollment-ongoing subjects will continue on
      treatment) to review drug safety, a new dose group of 10 mg (taken twice a day) may be added.

      Approximately 160 participants will be randomized in this study in approximately 22 study
      centers worldwide for the first part of this study. Following the Interim Analysis, 40 new
      participants may be added, for a total of 200 participants. The study is double blind, which
      means neither you nor your study doctor will know whether you are receiving the study
      medication or placebo.
    

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.