Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2008-04-30
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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1
Active medication Tozadenant 20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID
Tozadenant
20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID
2
Crossover from arm 1 to arm 2 with one week washout. One of the arms is placebo control
Placebo
Placebo oral capsules
Placebo for 7 days
Interventions
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Placebo
Placebo oral capsules
Placebo for 7 days
Tozadenant
20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
75 Years
ALL
No
Sponsors
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Biotie Therapies Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Steve Bandak, MB BS MRCP
Role: STUDY_CHAIR
Synosia Therapeutics
Ann Neale, RN
Role: STUDY_DIRECTOR
Synosia Therapeutics
Uwe Meya, MD
Role: STUDY_CHAIR
Synosia Therapeutics
Kevin J Black, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University St. Louis
St Louis, Missouri, United States
Countries
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References
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Black KJ, Campbell MC, Dickerson W, Creech ML, Koller JM, Chung SC, Bandak SI: A randomized, double-blind, placebo-controlled cross-over trial of the adenosine 2a antagonist SYN115 in Parkinson disease. Neurology 74(9): A317, 2010.
Black KJ, Koller JM, Campbell MC, Gusnard DA, Bandak SI. Quantification of indirect pathway inhibition by the adenosine A2a antagonist SYN115 in Parkinson disease. J Neurosci. 2010 Dec 1;30(48):16284-92. doi: 10.1523/JNEUROSCI.2590-10.2010.
Other Identifiers
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SYN115-CL01
Identifier Type: -
Identifier Source: org_study_id
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