Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off
A Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of SYN115 as Adjunctive Therapy in Levodopa-treated Parkinson's Subjects With End of Dose Wearing Off
1 other identifier
interventional
420
6 countries
61
Brief Summary
The purpose of this research study is to test the effect of SYN115 compared to placebo (a "sugar pill" that looks like SYN115 but does not include active drug) on movement during the "on" and "off" states as well as other symptoms that some patients with Parkinson's disease experience. This study will also look at whether or not patients with Parkinson's disease experience "side-effects" with SYN115.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2011
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2011
CompletedFirst Posted
Study publicly available on registry
January 26, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedJanuary 17, 2019
May 1, 2014
1.6 years
January 24, 2011
January 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Assess efficacy of different doses of SYN115 for reducing the mean total hours of awake time per day spent in the off state
12 weeks
Secondary Outcomes (6)
To assess the effect of SYN115 on dyskinesia
12 weeks
To assess the effect of SYN115 on UPDRS scores
12 weeks
To assess investigator and patient impressions of PD severity and change
12 weeks
To assess the effect of SYN115 on non motor symptoms of PD
12 weeks
To assess the safety and tolerability of SYN115
12 weeks
- +1 more secondary outcomes
Study Arms (5)
Tozadenant (SYN115) 60 mg BID
EXPERIMENTALTozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Tozadenant (SYN115) 120 mg BID
EXPERIMENTALTozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Tozadenant (SYN115) 180 mg BID
EXPERIMENTALTozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Tozadenant (SYN115) 240 mg BID
EXPERIMENTALTozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Sugar Pill
PLACEBO COMPARATORWhite-coated, modified-oval placebo tablets.
Interventions
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. Total daily doses include 60 mg BID.
One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. Total daily doses include 120 mg BID.
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. Total daily doses include 180 mg BID.
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. Total daily doses include 240 mg BID.
Eligibility Criteria
You may qualify if:
- Meet Parkinson's Disease (PD) diagnosis consistent with UK PD diagnostic 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.
You may not qualify if:
- Secondary or atypical Parkinson's
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (61)
Unknown Facility
Birmingham, Alabama, 35005, United States
Unknown Facility
La Jolla, California, 92037, United States
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Loma Linda, California, 92318, United States
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Los Angeles, California, 90001, United States
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Oxnard, California, 93030, United States
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San Francisco, California, 94016, United States
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Denver, Colorado, 80014, United States
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Manchester, Connecticut, 06040, United States
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New Haven, Connecticut, 06501, United States
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Boca Raton, Florida, 33427, United States
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Gainesville, Florida, 32601, United States
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Miami, Florida, 33101, United States
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Tampa, Florida, 33601, United States
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Weston, Florida, 33326, United States
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Atlanta, Georgia, 30301, United States
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Augusta, Georgia, 30901, United States
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Boise, Idaho, 83701, United States
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Springfield, Illinois, 62629, United States
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Indianapolis, Indiana, 46077, United States
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Des Moines, Iowa, 50047, United States
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Kansas City, Kansas, 66012, United States
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Lexington, Kentucky, 40502, United States
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Baltimore, Maryland, 21201, United States
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West Bloomfield, Michigan, 48302, United States
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Minneapolis, Minnesota, 55111, United States
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Commack, New York, 11725, United States
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New York, New York, 10001, United States
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Durham, North Carolina, 27517, United States
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Cincinnati, Ohio, 41073, United States
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Cleveland, Ohio, 44101, United States
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Columbus, Ohio, 43004, United States
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Toledo, Ohio, 43460, United States
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Tulsa, Oklahoma, 74008, United States
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Allentown, Pennsylvania, 18001, United States
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Philadelphia, Pennsylvania, 19019, United States
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Charleston, South Carolina, 29401, United States
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Dallas, Texas, 75001, United States
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Houston, Texas, 77001, United States
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Roanoke, Virginia, 24001, United States
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Milwaukee, Wisconsin, 53201, United States
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Buenos Aires, Argentina
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Santa Fe, Argentina
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Edmonton, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Ottawa, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Santiago, Chile
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Valdivia, Chile
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Brasov, Romania
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Bucharest, Romania
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Constanța, Romania
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Târgu Mureş, Romania
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Timișoara, Romania
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Kiev, Ukraine
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Lviv, Ukraine
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Poltava, Ukraine
Unknown Facility
Vinnytsia, Ukraine
Unknown Facility
Zaporizhzhya, Ukraine
Related Publications (1)
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.
PMID: 25008546DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Steve Bandak, MD
Biotie Therapies Inc.
- STUDY DIRECTOR
Ann Neale, RN
Biotie Therapies Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2011
First Posted
January 26, 2011
Study Start
March 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
January 17, 2019
Record last verified: 2014-05