Clinical trial NCT00605553: Study to Evaluate SYN115 in Parkinson's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Lead sponsor: Biotie Therapies Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-31
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: Before treatment and at the end of each treatment period
Secondary outcomes:
measure: Pittsburgh side effect scale
timeFrame: Before, after the first dose and end of each treatment period
measure: VAS for overall well being, dizziness/light-headedness, nausea/vomiting, mood anxiety
timeFrame: Before, after the first dose and end of each treatment period
measure: Measurement of motor symptoms of Parkinson's disease and tapping speed
timeFrame: Before, after the first dose and end of each treatment period
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University St. Louis
state: Missouri
Study officials:
affiliation: Synosia Therapeutics
name: Steve Bandak, MB BS MRCP
role: STUDY_CHAIR
affiliation: Synosia Therapeutics
name: Ann Neale, RN
role: STUDY_DIRECTOR
affiliation: Synosia Therapeutics
name: Uwe Meya, MD
role: STUDY_CHAIR
affiliation: Washington University School of Medicine
name: Kevin J Black, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.