Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients
NCT ID: NCT02453386
Last Updated: 2019-04-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
449 participants
INTERVENTIONAL
2015-07-31
2018-01-12
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Tozadenant 60 mg BID
During Part A, patients took two (2) tablets, one 60 mg tozadenant and one placebo, by mouth BID for a total of four (4) tablets per day.
Upon completion of Part A, all patients will begin dosing with open label tozadenant in Part B.
tozadenant
Tozadenant 120 mg BID
During Part A, patients took two (2) tablets of 60 mg tozadenant, by mouth BID for a total of four (4) tablets per day.
Upon completion of Part A, all patients will begin dosing with open label tozadenant in Part B.
tozadenant
Placebo BID
During Part A, patients took two (2) tablets of placebo, by mouth BID for a total of four (4) tablets per day.
Upon completion of Part A, all patients will begin dosing with open label tozadenant in Part B.
placebo
Interventions
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tozadenant
placebo
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
* 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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Biotie Therapies Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher Kenney, MD
Role: STUDY_DIRECTOR
Biotie Inc.
Locations
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Birmingham, Alabama, United States
Sun City, Arizona, United States
Loma Linda, California, United States
Los Angeles, California, United States
Oxnard, California, United States
Reseda, California, United States
Sacramento, California, United States
Sunnyvale, California, United States
Englewood, Colorado, United States
Vernon, Connecticut, United States
Boca Raton, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Lexington, Kentucky, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
East Lansing, Michigan, United States
Farmington Hills, Michigan, United States
West Bloomfield, Michigan, United States
St Louis, Missouri, United States
Albany, New York, United States
Commack, New York, United States
Rochester, New York, United States
Asheville, North Carolina, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Toledo, Ohio, United States
Tulsa, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Burlington, Vermont, United States
Roanoke, Virginia, United States
Kirkland, Washington, United States
Innsbruck, , Austria
Vienna, , Austria
Edmonton, Alberta, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Brno, , Czechia
Choceň, , Czechia
Pardubice, , Czechia
Prague, , Czechia
Rychnov nad Kněžnou, , Czechia
Beelitz-Heilstätten, , Germany
Berlin, , Germany
Dresden, , Germany
Haag in Oberbayern, , Germany
Marburg, , Germany
Ulm, , Germany
Arcugnano, , Italy
Cassino, , Italy
Chieti, , Italy
Grosseto, , Italy
Pavia, , Italy
Pisa, , Italy
Rome, , Italy
Salerno, , Italy
Venice, , Italy
Manresa, Barcelona, Spain
Sant Cugat del Vallès, Barcelona, Spain
Terrassa, Barcelona, Spain
Donostia / San Sebastian, Guipuzcoa, Spain
Barcelona, , Spain
Madrid, , Spain
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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2014-005630-60
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TOZ-CL05
Identifier Type: -
Identifier Source: org_study_id
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