Resumen

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.

Elegibilidad

Edad mínima: 30 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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
Finding of malignant melanoma on full body skin exam
Impulse disorder conditions

Intervenciones

drug

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.

drug

Placebo

White-coated, modified-oval placebo tablets.

drug

Levodopa (L-dopa)

One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.

drug

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.

drug

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.

drug

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.

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

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Tozadenant (SYN115) 60 mg BID

Placebo

Levodopa (L-dopa)

Tozadenant (SYN115) 120 mg BID

Tozadenant (SYN115) 180 mg BID

Tozadenant (SYN115) 240 mg BID

Ubicaciones

Patrocinadores