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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tozadenant (SYN115) 60 mg BID | Experimental | Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. |
|
| Tozadenant (SYN115) 120 mg BID | Experimental | Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. |
|
| Tozadenant (SYN115) 180 mg BID | Experimental | Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. |
|
| Tozadenant (SYN115) 240 mg BID | Experimental | Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. |
|
| Sugar Pill | Placebo Comparator | White-coated, modified-oval placebo tablets. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tozadenant (SYN115) 60 mg BID | Drug | Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. Total daily doses include 60 mg BID. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Bandak, MD | Biotie Therapies Inc. | Study Chair |
| Ann Neale, RN | Biotie Therapies Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35005 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25008546 | Derived | 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. |
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| Placebo | Drug | White-coated, modified-oval placebo tablets. |
|
| Levodopa (L-dopa) | Drug | One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration. |
|
|
| Tozadenant (SYN115) 120 mg BID | Drug | 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 | Drug | 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 | Drug | Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. Total daily doses include 240 mg BID. |
|
| 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 |
| To assess the effects of SYN115 on daytime drowsiness, impulsive behavior, development of melanoma and suicidal ideation | 12 weeks |
| La Jolla |
| California |
| 92037 |
| United States |
| Loma Linda | California | 92318 | United States |
| Los Angeles | California | 90001 | United States |
| Oxnard | California | 93030 | United States |
| San Francisco | California | 94016 | United States |
| Denver | Colorado | 80014 | United States |
| Manchester | Connecticut | 06040 | United States |
| New Haven | Connecticut | 06501 | United States |
| Boca Raton | Florida | 33427 | United States |
| Gainesville | Florida | 32601 | United States |
| Miami | Florida | 33101 | United States |
| Tampa | Florida | 33601 | United States |
| Weston | Florida | 33326 | United States |
| Atlanta | Georgia | 30301 | United States |
| Augusta | Georgia | 30901 | United States |
| Boise | Idaho | 83701 | United States |
| Springfield | Illinois | 62629 | United States |
| Indianapolis | Indiana | 46077 | United States |
| Des Moines | Iowa | 50047 | United States |
| Kansas City | Kansas | 66012 | United States |
| Lexington | Kentucky | 40502 | United States |
| Baltimore | Maryland | 21201 | United States |
| West Bloomfield | Michigan | 48302 | United States |
| Minneapolis | Minnesota | 55111 | United States |
| Commack | New York | 11725 | United States |
| New York | New York | 10001 | United States |
| Durham | North Carolina | 27517 | United States |
| Cincinnati | Ohio | 41073 | United States |
| Cleveland | Ohio | 44101 | United States |
| Columbus | Ohio | 43004 | United States |
| Toledo | Ohio | 43460 | United States |
| Tulsa | Oklahoma | 74008 | United States |
| Allentown | Pennsylvania | 18001 | United States |
| Philadelphia | Pennsylvania | 19019 | United States |
| Charleston | South Carolina | 29401 | United States |
| Dallas | Texas | 75001 | United States |
| Houston | Texas | 77001 | United States |
| Roanoke | Virginia | 24001 | United States |
| Milwaukee | Wisconsin | 53201 | 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 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| C000593256 | tozadenant |
| C494814 | BID protein, human |
| D007980 | Levodopa |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |
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