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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
420
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. Total daily doses include 60 mg BID.
White-coated, modified-oval placebo tablets.
One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.
Assess efficacy of different doses of SYN115 for reducing the mean total hours of awake time per day spent in the off state
Time frame: 12 weeks
To assess the effect of SYN115 on dyskinesia
Time frame: 12 weeks
To assess the effect of SYN115 on UPDRS scores
Time frame: 12 weeks
To assess investigator and patient impressions of PD severity and change
Time frame: 12 weeks
To assess the effect of SYN115 on non motor symptoms of PD
Time frame: 12 weeks
To assess the safety and tolerability of SYN115
Time frame: 12 weeks
To assess the effects of SYN115 on daytime drowsiness, impulsive behavior, development of melanoma and suicidal ideation
Time frame: 12 weeks
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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.
Unnamed facility
Birmingham, Alabama, United States
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La Jolla, California, United States
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Loma Linda, California, United States
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Los Angeles, California, United States
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Oxnard, California, United States
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San Francisco, California, United States
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Denver, Colorado, United States
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Manchester, Connecticut, United States
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New Haven, Connecticut, United States
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Boca Raton, Florida, United States
...and 51 more locations