Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease.
NCT ID: NCT03051607
Last Updated: 2019-05-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
66 participants
INTERVENTIONAL
2017-04-10
2018-01-16
Brief Summary
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Detailed Description
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* Screening Period: up to 6 weeks.
* Open-Label Treatment Period: 52 weeks (1 year)
* Post-Treatment Safety Follow Up: 4 weeks.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tozadenant
120 mg twice daily. At Week 2 or thereafter doses of 60 mg BID and 120 mg BID will be permitted.
Tozadenant
1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted.
Interventions
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Tozadenant
1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
80 Years
ALL
No
Sponsors
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Acorda Therapeutics
INDUSTRY
Biotie Therapies Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher Kenney, MD
Role: STUDY_DIRECTOR
Acorda Therapeutics
Locations
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Barrow Neurology Clinics, St. Joseph's Hospital and Medical Center, Dignity Health
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Collaborative Neuroscience Network, LLC
Long Beach, California, United States
USC, Keck School of Medicine
Los Angeles, California, United States
SC3 Research Group
Pasadena, California, United States
JEM Research Institute
Atlantis, Florida, United States
Aventura Neurologic Associates
Aventura, Florida, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
Neurology Associates, P.A.
Maitland, Florida, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, United States
Parkinson's Disease Treatment Center of SW Florida
Port Charlotte, Florida, United States
Infinity Clinical Research
Sunrise, Florida, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
Unity Point Health
Des Moines, Iowa, United States
Unity Point Health
Des Moines, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky, Department of Neurology
Lexington, Kentucky, United States
Henry Ford West Bloomfield Hospital
Bloomfield Hills, Michigan, United States
Struthers Parkinson's Center
Golden Valley, Minnesota, United States
Struthers Parkinson's Center
Golden Valley, Minnesota, United States
The Robert and John M. Bendheim Parkinson and Movement Disorders Center
New York, New York, United States
Asheville Neurology Specialists, PA
Asheville, North Carolina, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
Movement Disorders Clinic of Oklahoma
Tulsa, Oklahoma, United States
Abington Neurological Associates
Willow Grove, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
University of Virginia, Department of Neurology
Charlottesville, Virginia, United States
Booth Gardner Parkinson's Care Center
Kirkland, Washington, United States
Premier Clinical Research
Spokane, Washington, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
University of Wisconsin - Madison
Madison, Wisconsin, United States
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
The Walton Centre NHS Foundation Trust, Neuroscience Research Center
Liverpool, England, United Kingdom
Newcastle University Clinical Ageing Research Unit (CARU)
Newcastle upon Tyne, England, United Kingdom
The Queen Elizabeth University Hospital Department of Neurology
Glasgow, Scottland, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TOZ-CL06
Identifier Type: -
Identifier Source: org_study_id
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