Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease.

Exclusion Criteria

• •Previous tozadenant study participation
• •Current or recent participation in another study.
• •Secondary or atypical parkinsonism
• •Neurosurgical intervention for PD (except DBS if electrode placement has been performed over 12 months prior to screening)
• •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