A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson´s DiseaseExperiencing End-of-Dose Wearing-Off (TOZ-PD)
- Conditions
- Parkinson´s DiseaseMedDRA version: 18.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-005630-60-ES
- Lead Sponsor
- Biotie Therapies Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 449
? 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 158
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 292
? 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method