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Study to Evaluate SYN115 in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Tozadenant
Sponsored by
Biotie Therapies Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University St. Louis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pittsburgh side effect scale
VAS for overall well being, dizziness/light-headedness, nausea/vomiting, mood anxiety
Measurement of motor symptoms of Parkinson's disease and tapping speed

Full Information

First Posted
January 15, 2008
Last Updated
August 3, 2017
Sponsor
Biotie Therapies Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00605553
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotie Therapies Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Active medication Tozadenant 20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Crossover from arm 1 to arm 2 with one week washout. One of the arms is placebo control
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral capsules Placebo for 7 days
Intervention Type
Drug
Intervention Name(s)
Tozadenant
Other Intervention Name(s)
A2a antagonist, SYN115
Intervention Description
20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Pittsburgh side effect scale
Time Frame
Before, after the first dose and end of each treatment period
Title
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
Title
Measurement of motor symptoms of Parkinson's disease and tapping speed
Time Frame
Before, after the first dose and end of each treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Bandak, MB BS MRCP
Organizational Affiliation
Synosia Therapeutics
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ann Neale, RN
Organizational Affiliation
Synosia Therapeutics
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Uwe Meya, MD
Organizational Affiliation
Synosia Therapeutics
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kevin J Black, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
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.
Results Reference
result
PubMed Identifier
21123574
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.
Results Reference
result

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Study to Evaluate SYN115 in Parkinson's Disease

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