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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Placebo oral capsules Placebo for 7 days
20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID
Washington University St. Louis
St Louis, Missouri, United States
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.
Time frame: Before treatment and at the end of each treatment period
Pittsburgh side effect scale
Time frame: Before, after the first dose and end of each treatment period
VAS for overall well being, dizziness/light-headedness, nausea/vomiting, mood anxiety
Time frame: Before, after the first dose and end of each treatment period
Measurement of motor symptoms of Parkinson's disease and tapping speed
Time frame: Before, after the first dose and end of each treatment period
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