Study to Evaluate SYN115 in Parkinson's Disease
Completed · Phase 2 · Has a placebo group
Conditions studied: Parkinson's Disease
In brief
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.
Key facts
- Study ID
- NCT00605553
- Run by
- Biotie Therapies Inc.
- People needed
- 30
- Starts
- 2008-04-01
- Expected to finish
- 2009-05-01
- Last updated by the study team
- 2017-08-08
Who can join
Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Washington University St. Louis — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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