Clinical trial NCT02453386: Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Idiopathic Parkinson's Disease
Keywords: Motor fluctuations
Off time
On time
Dyskinesia
Lead sponsor: Biotie Therapies Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-25
Enrollment: 449
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

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
* 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

Primary outcomes:
measure: Change From Baseline to Week 24 in the Number of Hours Per Day Spent in OFF Time
timeFrame: Baseline to 24 Weeks
Secondary outcomes:
measure: Change in Good ON Time From Baseline to Week 24
timeFrame: Baseline to 24 Weeks
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Activities of Daily Living (ADL) Subscale + Part III Motor Function
timeFrame: Baseline to Week 24
measure: Change From Baseline to Week 24 in the ON State in Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl
timeFrame: Baseline to Week 24
Other outcomes:
measure: Global Assessments of Improvement: Clinical Global Impression of Improvement (CGI-I) Week 24
timeFrame: At Week 24
measure: Patient Global Impression of Improvement (PGI-I) Week 24
timeFrame: At Week 24
Locations:
city: Birmingham
country: United States
state: Alabama
city: Sun City
country: United States
state: Arizona
city: Loma Linda
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Oxnard
country: United States
state: California
city: Reseda
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Sunnyvale
country: United States
state: California
city: Englewood
country: United States
state: Colorado
city: Vernon
country: United States
state: Connecticut
city: Boca Raton
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Kansas City
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: East Lansing
country: United States
state: Michigan
city: Farmington Hills
country: United States
state: Michigan
city: West Bloomfield
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: Albany
country: United States
state: New York
city: Commack
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Roanoke
country: United States
state: Virginia
city: Kirkland
country: United States
state: Washington
city: Innsbruck
country: Austria
city: Vienna
country: Austria
city: Edmonton
country: Canada
state: Alberta
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Brno
country: Czechia
city: Chocen
country: Czechia
city: Pardubice
country: Czechia
city: Prague
country: Czechia
city: Rychnov nad Kneznou
country: Czechia
city: Beelitz-Heilstätten
country: Germany
city: Berlin
country: Germany
city: Dresden
country: Germany
city: Haag in Oberbayern
country: Germany
city: Marburg
country: Germany
city: Ulm
country: Germany
city: Arcugnano
country: Italy
city: Cassino
country: Italy
city: Chieti
country: Italy
city: Grosseto
country: Italy
city: Pavia
country: Italy
city: Pisa
country: Italy
city: Rome
country: Italy
city: Salerno
country: Italy
city: Venice
country: Italy
city: Manresa
country: Spain
state: Barcelona
city: Sant Cugat del Valles
country: Spain
state: Barcelona
city: Terrassa
country: Spain
state: Barcelona
city: San Sebastian
country: Spain
state: Guipuzcoa
city: Barcelona
country: Spain
city: Madrid
country: Spain
Study officials:
affiliation: Biotie Inc.
name: Christopher Kenney, MD
role: STUDY_DIRECTOR
References: