Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off
NCT ID: NCT01283594
Last Updated: 2019-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
420 participants
INTERVENTIONAL
2011-03-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Tozadenant (SYN115) 60 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Tozadenant (SYN115) 60 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Total daily doses include 60 mg BID.
Levodopa (L-dopa)
One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.
Tozadenant (SYN115) 120 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Levodopa (L-dopa)
One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.
Tozadenant (SYN115) 120 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Total daily doses include 120 mg BID.
Tozadenant (SYN115) 180 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Levodopa (L-dopa)
One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.
Tozadenant (SYN115) 180 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Total daily doses include 180 mg BID.
Tozadenant (SYN115) 240 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Tozadenant (SYN115) 240 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Total daily doses include 240 mg BID.
Levodopa (L-dopa)
One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.
Sugar Pill
White-coated, modified-oval placebo tablets.
Placebo
White-coated, modified-oval placebo tablets.
Levodopa (L-dopa)
One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.
Interventions
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Tozadenant (SYN115) 240 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Total daily doses include 240 mg BID.
Tozadenant (SYN115) 60 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Total daily doses include 60 mg BID.
Placebo
White-coated, modified-oval placebo tablets.
Levodopa (L-dopa)
One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.
Tozadenant (SYN115) 120 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Total daily doses include 120 mg BID.
Tozadenant (SYN115) 180 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Total daily doses include 180 mg BID.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Meet Hoehn and Yahr PD stage
* Good response to levodopa
* Stable regimen of anti-parkinson medications
* Are able to complete a Parkinson's disease diary
* If of childbearing potential(male and female), use an acceptable method of birth control
* Able and willing to sign an IRB/IEC approved informed consent
* Able and willing to understand study requirements, follow study instructions, attend all visits and undergo all planned tests.
Exclusion Criteria
* Neurosurgical intervention for Parkinson's disease
* Treatment with apomorphine
* Treatment with anti-psychotic drugs
* Other abnormal findings on physical or neuro exam or history that in the opinion of the investigator would make subject unsuitable for the study or prejudice safety and efficacy evaluation
* MMSE less than 26
* Subjects with untreated or uncontrolled current episode of major depression
* Receipt of any anti-psychotic drugs greater than 1 month in the past 5 years or any exposure in past year (except for quetiapine at doses \<100mg per day)
* Women pregnant or lactating
* History of hepatitis, cholangitis
* Untreated or uncontrolled hypothyroidism or hyperthyroidism
* Drops in blood pressure requiring medication to maintain blood pressure
* Any clinically significant out of range laboratory evaluations
* Known sensitivity to the study medication or its components
* Suicide ideation or type 4 or type 5 on the Columbia suicide severity rating scale
* Finding of malignant melanoma on full body skin exam
* Impulse disorder conditions
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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Steve Bandak, MD
Role: STUDY_CHAIR
Biotie Therapies Inc.
Ann Neale, RN
Role: STUDY_DIRECTOR
Biotie Therapies Inc.
Locations
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Birmingham, Alabama, United States
La Jolla, California, United States
Loma Linda, California, United States
Los Angeles, California, United States
Oxnard, California, United States
San Francisco, California, United States
Denver, Colorado, United States
Manchester, Connecticut, United States
New Haven, Connecticut, United States
Boca Raton, Florida, United States
Gainesville, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Weston, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Boise, Idaho, United States
Springfield, Illinois, United States
Indianapolis, Indiana, United States
Des Moines, Iowa, United States
Kansas City, Kansas, United States
Lexington, Kentucky, United States
Baltimore, Maryland, United States
West Bloomfield, Michigan, United States
Minneapolis, Minnesota, United States
Commack, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
Tulsa, Oklahoma, United States
Allentown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Dallas, Texas, United States
Houston, Texas, United States
Roanoke, Virginia, United States
Milwaukee, Wisconsin, United States
Buenos Aires, , Argentina
Santa Fe, , Argentina
Edmonton, Alberta, Canada
Halifax, Nova Scotia, Canada
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Santiago, , Chile
Valdivia, , Chile
Brasov, , Romania
Bucharest, , Romania
Constanța, , Romania
Târgu Mureş, , Romania
Timișoara, , Romania
Dnipropetrovsk, , Ukraine
Donetsk, , Ukraine
Kiev, , Ukraine
Lviv, , Ukraine
Poltava, , Ukraine
Vinnytsia, , Ukraine
Zaporizhzhya, , Ukraine
Countries
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References
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Hauser RA, Olanow CW, Kieburtz KD, Pourcher E, Docu-Axelerad A, Lew M, Kozyolkin O, Neale A, Resburg C, Meya U, Kenney C, Bandak S. Tozadenant (SYN115) in patients with Parkinson's disease who have motor fluctuations on levodopa: a phase 2b, double-blind, randomised trial. Lancet Neurol. 2014 Aug;13(8):767-76. doi: 10.1016/S1474-4422(14)70148-6. Epub 2014 Jul 6.
Other Identifiers
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SYN115-CL02
Identifier Type: -
Identifier Source: org_study_id
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