
    new safety information
  
["idiopathic parkinson's disease"]
['tozadenant', 'placebo']

        Inclusion Criteria:

          -  Patient understands study requirements and has given his/her written informed consent
             on an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved
             consent form.

          -  Parkinson's disease diagnosis consistent with UK Parkinson's Disease Society Brain
             Bank Diagnostic criteria

          -  Minimum of 3 years since diagnosis.

          -  Meet Hoehn and Yahr PD stage

          -  Good response to levodopa

          -  Stable regimen of anti-PD medications

          -  Patients must have been taking a levodopa-containing anti-PD medication continuously
             for at least the previous 12 months

          -  Patient has documented a minimum amount of Off time.

          -  If of childbearing potential (male and female) must use an acceptable method of
             contraception

        Exclusion Criteria:

          -  Previous tozadenant study participation

          -  Current or recent participation in another study.

          -  Secondary or atypical parkinsonism

          -  Neurosurgical intervention for PD

          -  Patient is taking apomorphine, budipine, istradefylline, tolcapone, or DUOPA™/Duodopa®

          -  Treatment with excluded medications

          -  Untreated or uncontrolled hyperthyroidism or hypothyroidism

          -  Clinically significant out-of-range laboratory

          -  MMSE out of range

          -  Current episode of major depression (stable treatment for depression is permitted).

          -  Recent suicide attempt or suicidal ideation type 4 or type 5 of the Columbia-Suicide
             Severity Rating Scale (C-SSRS)

          -  Women lactating or pregnant

          -  Hypersensitivity to any components of tozadenant or excipients

          -  Abnormal findings on the physical or neurological examination, or medical history that
             would make the patient unsuitable for the study

          -  History of hepatitis or cholangitis
      