Clinical trial NCT03051607: Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease.
Official title: A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose "Wearing-Off"
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Idiopathic Parkinson Disease
Keywords: Motor Fluctuations
Off time
On time
Dyskinesia
Lead sponsor: Biotie Therapies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Acorda Therapeutics
First posted: 2017-02-13
Enrollment: 66
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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

Detailed description: Each patient will participate for up to 52 weeks, which includes a Screening Period, followed by a Baseline Visit and open-label treatment for 1 year with a safety Follow-up 4 weeks after the last treatment.

* Screening Period: up to 6 weeks.
* Open-Label Treatment Period: 52 weeks (1 year)
* 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 (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

Primary outcomes:
measure: To Evaluate the Safety and Tolerability of Tozadenant in Levodopa-treated PD Patients Experiencing Motor Fluctuations.
timeFrame: Up to 28 Weeks including safety follow-up visit.
Secondary outcomes:
measure: To Evaluate the Effects of Tozadenant on the Occurrences of Daytime Drowsiness by Using the Epworth Sleepiness Scale.
timeFrame: Up to 28 Weeks including safety follow-up visit.
measure: To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
timeFrame: Up to 28 Weeks including safety follow-up visit.
measure: To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
timeFrame: Up to 28 Weeks including safety follow-up visit.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurology Clinics, St. Joseph's Hospital and Medical Center, Dignity Health
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: Los Angeles
country: United States
facility: USC, Keck School of Medicine
state: California
city: Pasadena
country: United States
facility: SC3 Research Group
state: California
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Aventura
country: United States
facility: Aventura Neurologic Associates
state: Florida
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: Maitland
country: United States
facility: Neurology Associates, P.A.
state: Florida
city: Ormond Beach
country: United States
facility: Neurology Associates of Ormond Beach
state: Florida
city: Port Charlotte
country: United States
facility: Parkinson's Disease Treatment Center of SW Florida
state: Florida
city: Sunrise
country: United States
facility: Infinity Clinical Research
state: Florida
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience
state: Hawaii
city: Des Moines
country: United States
facility: Unity Point Health
state: Iowa
city: Des Moines
country: United States
facility: Unity Point Health
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky, Department of Neurology
state: Kentucky
city: Bloomfield Hills
country: United States
facility: Henry Ford West Bloomfield Hospital
state: Michigan
city: Golden Valley
country: United States
facility: Struthers Parkinson's Center
state: Minnesota
city: Golden Valley
country: United States
facility: Struthers Parkinson's Center
state: Minnesota
city: New York
country: United States
facility: The Robert and John M. Bendheim Parkinson and Movement Disorders Center
state: New York
city: Asheville
country: United States
facility: Asheville Neurology Specialists, PA
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Tulsa
country: United States
facility: Movement Disorders Clinic of Oklahoma
state: Oklahoma
city: Willow Grove
country: United States
facility: Abington Neurological Associates
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia, Department of Neurology
state: Virginia
city: Kirkland
country: United States
facility: Booth Gardner Parkinson's Care Center
state: Washington
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
city: Liverpool
country: United Kingdom
facility: The Walton Centre NHS Foundation Trust, Neuroscience Research Center
state: England
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle University Clinical Ageing Research Unit (CARU)
state: England
city: Glasgow
country: United Kingdom
facility: The Queen Elizabeth University Hospital Department of Neurology
state: Scottland
Study officials:
affiliation: Acorda Therapeutics
name: Christopher Kenney, MD
role: STUDY_DIRECTOR
References: