Study to Evaluate SYN115 in Parkinson's Disease

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605553
• Other study ID #: SYN115-CL01
• Status: Completed
• Phase: Phase 2
• First received: January 15, 2008
• Last updated: August 3, 2017
• Start date: April 2008
• Est. completion date: May 2009

Study information

• Verified date: August 2017
• Source: Biotie Therapies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Washington University St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Biotie Therapies Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Pittsburgh side effect scale		Before, after the first dose and end of each treatment period
Secondary	VAS for overall well being, dizziness/light-headedness, nausea/vomiting, mood anxiety		Before, after the first dose and end of each treatment period
Secondary	Measurement of motor symptoms of Parkinson's disease and tapping speed		Before, after the first dose and end of each treatment period