Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease.
Condition: Idiopathic Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: Tozadenant
Intervention description: 1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Eligible patients will begin dosing with tozadenant at a dose of 120 mg twice daily. At Week 2 or thereafter, the investigator may adjust the patient's IMP dose as clinically indicated; doses of 60 mg BID and 120 mg BID will be permitted.
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Motor Fluctuations; Off time; On time; Dyskinesia

Summary:

      Phase 3, international, multicenter, open-label 12 month safety study.
    

Eligibility criteria:

        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 (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