Trial | NCT00605553  Report issue

Title

Study to Evaluate SYN115 in Parkinson's Disease
A Randomized, Double-blind, Placebo Controlled, Two-way Cross-over Study to Explore the Effects of 7 Days of Dosing With SYN115 20 mg p.o. BID or 60 mg p.o. BID on Clinical and fMRI Response to Intravenous Levodopa in Patients With Mild to Moderate Parkinson's Disease

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    tozadenant ...

  • Study Participants

    30
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 Started
Apr 30
2008
Primary Completion
May 31
2009
Study Completion
May 31
2009
Last Update
Aug 08
2017

Drug Placebo

Placebo oral capsules Placebo for 7 days

Drug Tozadenant

20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID

  • Other names: A2a antagonist, SYN115

1 Experimental

Active medication Tozadenant 20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID

2 Placebo Comparator

Crossover from arm 1 to arm 2 with one week washout. One of the arms is placebo control

Criteria 

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
No Results Posted