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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo oral capsules Placebo for 7 days |
| |
| Tozadenant |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Bandak, MB BS MRCP | Synosia Therapeutics | Study Chair |
| Ann Neale, RN | Synosia Therapeutics | Study Director |
| Uwe Meya, MD | Synosia Therapeutics | Study Chair |
| Kevin J Black, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University St. Louis | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| 21123574 | Result | 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. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C000593256 | tozadenant |
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| Drug |
20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID |
|
|
| Measurement of motor symptoms of Parkinson's disease and tapping speed | Before, after the first dose and end of each treatment period |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |