Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients

• Status: Terminated
• Trial end date: 2018-01-12
• Target enrollment: 0
• Participant gender: All

Summary

Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 3-arm safety and efficacy study (Part A) with an open-label phase (Part B).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biotie Therapies Inc.
• Treatments: Levodopa

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

• 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