Parkinson's Disease
Conditions
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.
Interventions
DRUGPlacebo
Placebo oral capsules Placebo for 7 days
DRUGTozadenant
20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID
Sponsors
Biotie Therapies Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Parkinson's disease * Hoen and Yahr stage 1-3 * On stable dose of anti-parkinsons treatment for 30 days prior to screening * Age 40 to 75 years * Sign an IRB approved informed consent * Men and women agree to use adequate birth control * ECG measurements are within normal limits * Able to understand study requirements
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Pittsburgh side effect scale | 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 |
| Measurement of motor symptoms of Parkinson's disease and tapping speed | Before, after the first dose and end of each treatment period |
Countries
United States
Outcome results
None listed