Study to Evaluate SYN115 in Parkinson's Disease

• ClinicalTrials.gov Identifier: NCT00605553
• Recruitment Status: Completed
• First Posted: January 31, 2008
• Last Update Posted: August 8, 2017
• Sponsor: Biotie Therapies Inc.
• Information provided by (Responsible Party): Biotie Therapies Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Parkinson's Disease	Drug: Placebo; Drug: Tozadenant	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: April 2008
• Actual Primary Completion Date: May 2009
• Actual Study Completion Date: May 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; Active medication Tozadenant 20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID	Drug: Tozadenant; 20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID; Other Names: A2a antagonist; SYN115
Placebo Comparator: 2; Crossover from arm 1 to arm 2 with one week washout. One of the arms is placebo control	Drug: Placebo; Placebo oral capsules Placebo for 7 days

Outcome Measures

Primary Outcome Measures :

1. 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. [ Time Frame: Before treatment and at the end of each treatment period ]

Secondary Outcome Measures :

1. Pittsburgh side effect scale [ Time Frame: Before, after the first dose and end of each treatment period ]
2. VAS for overall well being, dizziness/light-headedness, nausea/vomiting, mood anxiety [ Time Frame: Before, after the first dose and end of each treatment period ]
3. Measurement of motor symptoms of Parkinson's disease and tapping speed [ Time Frame: Before, after the first dose and end of each treatment period ]

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Missouri

Washington University St. Louis

Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

Biotie Therapies Inc.

Investigators

• Study Chair: Steve Bandak, MB BS MRCP; Synosia Therapeutics
• Study Director: Ann Neale, RN; Synosia Therapeutics
• Study Chair: Uwe Meya, MD; Synosia Therapeutics
• Principal Investigator: Kevin J Black, MD; Washington University School of Medicine

More Information

Publications of Results:

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.

• Responsible Party: Biotie Therapies Inc.
• ClinicalTrials.gov Identifier: NCT00605553
• Other Study ID Numbers: SYN115-CL01
• First Posted: January 31, 2008
• Last Update Posted: August 8, 2017
• Last Verified: August 2017

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases