A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Phase to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose "Wearing-Off" (TOZ-PD)

  • STATUS
    Recruiting
  • sponsor
    Biotie Therapies Inc.
Updated on 23 November 2020

Summary

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Phase to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose "Wearing-Off" (TOZ-PD)

Description

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).

Protocol Number: TOZ-CL05

Detailed Description:

During Part A, each patient will participate for up to 30 weeks, which includes a Screening Period of 1 to ≤ 6 weeks, followed by a Baseline Visit and 24 weeks of double-blind treatment: •Screening Period: 1 - 6 weeks. •Double-Blind Treatment Period: 24 weeks. After completion of Part A, patients will continue in Part B for an additional 56 weeks: •Open-Label Treatment Period: 52 weeks. •Post-Treatment Safety Follow Up: 4 weeks.

Details
Clinical Study IdentifierTX141121
SponsorBiotie Therapies Inc.
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

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
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