Study to Evaluate SYN115 in Parkinson's Disease

Phase 2

Completed

Brief Summary: This is an exploratory study to evaluate if SYN115 has an effect on Parkinson's disease as measured by clinical symptoms and brain images using magnetic resonance imaging (MRI) when a function test is administered.

Detailed Description: This is a randomized, double-blind, placebo-controlled, two-way crossover study in which each patient will act as their own control. Each patient enrolled will receive both SYN115 (20 mg or 60 mg) and placebo separated by a minimum of one week washout between periods. An adaptive design will be used to determine if SYN115 elicits effects relevant to PD in the fewest number of patients by performing interim analyses in successive cohorts of patients receiving 60 or 20 mg.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Secondary Parkinson's (drug induced or post stroke)
Received treatment with other investigational drug 30 days prior to study entry
Using disallowed medications
Significant neurological illness other than Parkinson's
IQ less than 70 on IQ test
MMSE score < or = 23
History of psychosis or on anti-psychotic medication
Current serious medical illness
History of substance abuse
History of head injury with loss of consciousness
History of brain surgery
Contraindications to MRI like claustrophobia, metal implants or other implantable devices
Abnormal liver function tests and/or hepatitis or cholangitis
Gilberts disease
Pregnant or nursing
Known hypersensitivity to SYN115

Arm && Interventions

Group	Intervention	Description
2	Placebo	Crossover from arm 1 to arm 2 with one week washout. One of the arms is placebo control
1	Tozadenant	Active medication Tozadenant 20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID

Primary Outcome Measures

Name	Time	Method
This is an exploratory study to evaluate effects of SYN115 in patients with PD, as determined by clinical and fMRI evaluation. The results of this initial study will help determine the range to be used in subsequent studies.	Before treatment and at the end of each treatment period

Secondary Outcome Measures

Name	Time	Method
Pittsburgh side effect scale	Before, after the first dose and end of each treatment period
Measurement of motor symptoms of Parkinson's disease and tapping speed	Before, after the first dose and end of each treatment period
VAS for overall well being, dizziness/light-headedness, nausea/vomiting, mood anxiety	Before, after the first dose and end of each treatment period