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Trial record 1 of 1 for:    NCT00605553
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Study to Evaluate SYN115 in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00605553
Recruitment Status : Completed
First Posted : January 31, 2008
Last Update Posted : August 8, 2017
Information provided by (Responsible Party):
Biotie Therapies Inc.

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.

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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

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

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 ]

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00605553

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United States, Missouri
Washington University St. Louis
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Biotie Therapies Inc.
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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
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.

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Responsible Party: Biotie Therapies Inc. Identifier: NCT00605553    
Other Study ID Numbers: SYN115-CL01
First Posted: January 31, 2008    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases