Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off

Last updated: January 14, 2019
Sponsor: Biotie Therapies Inc.
Overall Status: Completed

Phase

2/3

Condition

Dyskinesias

Parkinson's Disease

Treatment

N/A

Clinical Study ID

NCT01283594
SYN115-CL02
  • Ages 30-80
  • All Genders

Study Summary

The purpose of this research study is to test the effect of SYN115 compared to placebo (a "sugar pill" that looks like SYN115 but does not include active drug) on movement during the "on" and "off" states as well as other symptoms that some patients with Parkinson's disease experience. This study will also look at whether or not patients with Parkinson's disease experience "side-effects" with SYN115.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meet Parkinson's Disease (PD) diagnosis consistent with UK PD diagnostic criteria

  • Meet Hoehn and Yahr PD stage

  • Good response to levodopa

  • Stable regimen of anti-parkinson medications

  • Are able to complete a Parkinson's disease diary

  • If of childbearing potential(male and female), use an acceptable method of birthcontrol

  • Able and willing to sign an IRB/IEC approved informed consent

  • Able and willing to understand study requirements, follow study instructions, attendall visits and undergo all planned tests.

Exclusion

Exclusion Criteria:

  • Secondary or atypical Parkinson's

  • Neurosurgical intervention for Parkinson's disease

  • Treatment with apomorphine

  • Treatment with anti-psychotic drugs

  • Other abnormal findings on physical or neuro exam or history that in the opinion ofthe investigator would make subject unsuitable for the study or prejudice safety andefficacy evaluation

  • MMSE less than 26

  • Subjects with untreated or uncontrolled current episode of major depression

  • Receipt of any anti-psychotic drugs greater than 1 month in the past 5 years or anyexposure in past year (except for quetiapine at doses <100mg per day)

  • Women pregnant or lactating

  • History of hepatitis, cholangitis

  • Untreated or uncontrolled hypothyroidism or hyperthyroidism

  • Drops in blood pressure requiring medication to maintain blood pressure

  • Any clinically significant out of range laboratory evaluations

  • Known sensitivity to the study medication or its components

  • Suicide ideation or type 4 or type 5 on the Columbia suicide severity rating scale

  • Finding of malignant melanoma on full body skin exam

  • Impulse disorder conditions

Study Design

Total Participants: 420
Study Start date:
March 01, 2011
Estimated Completion Date:
October 31, 2012

Connect with a study center

  • Buenos Aires,
    Argentina

    Site Not Available

  • Santa Fe,
    Argentina

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  • Edmonton, Alberta
    Canada

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  • Halifax, Nova Scotia
    Canada

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    London, Ontario
    Canada

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  • Ottawa, Ontario
    Canada

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  • Montreal, Quebec
    Canada

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  • Quebec City, Quebec
    Canada

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  • Santiago,
    Chile

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  • Valdivia,
    Chile

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  • Brasov,
    Romania

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  • Bucharest,
    Romania

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  • Constanta,
    Romania

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    Mures,
    Romania

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  • Timisoara,
    Romania

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  • Târgu-Mureş,
    Romania

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  • Dnipropetrovsk,
    Ukraine

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  • Donetsk,
    Ukraine

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  • Kiev,
    Ukraine

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  • Lviv,
    Ukraine

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  • Poltava,
    Ukraine

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  • Vinnytsia,
    Ukraine

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  • Zaporizhzhya,
    Ukraine

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  • Birmingham, Alabama 35005
    United States

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    Chicago, California
    United States

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  • La Jolla, California 92037
    United States

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  • Loma Linda, California 92318
    United States

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  • Los Angeles, California 90001
    United States

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  • Oxnard, California 93030
    United States

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  • San Francisco, California 94016
    United States

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  • Denver, Colorado 80014
    United States

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  • Manchester, Connecticut 06040
    United States

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  • New Haven, Connecticut 06501
    United States

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  • Boca Raton, Florida 33427
    United States

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  • Gainesville, Florida 32601
    United States

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    Gainsville, Florida
    United States

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  • Miami, Florida 33101
    United States

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  • Tampa, Florida 33601
    United States

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  • Weston, Florida 33326
    United States

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  • Atlanta, Georgia 30301
    United States

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  • Augusta, Georgia 30901
    United States

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  • Boise, Idaho 83701
    United States

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  • Springfield, Illinois 62629
    United States

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  • Indianapolis, Indiana 46077
    United States

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  • Des Moines, Iowa 50047
    United States

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  • Kansas City, Kansas 66012
    United States

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  • Lexington, Kentucky 40502
    United States

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  • Baltimore, Maryland 21201
    United States

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    Elkridge, Maryland
    United States

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  • West Bloomfield, Michigan 48302
    United States

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    West Bloomfield Township, Michigan
    United States

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  • Minneapolis, Minnesota 55111
    United States

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    New Brunswick, New Jersey
    United States

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    Comack, New York
    United States

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  • Commack, New York 11725
    United States

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  • New York, New York 10001
    United States

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  • Durham, North Carolina 27517
    United States

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  • Cincinnati, Ohio 41073
    United States

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  • Cleveland, Ohio 44101
    United States

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  • Columbus, Ohio 43004
    United States

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  • Toledo, Ohio 43460
    United States

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  • Tulsa, Oklahoma 74008
    United States

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  • Allentown, Pennsylvania 18001
    United States

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  • Philadelphia, Pennsylvania 19019
    United States

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  • Charleston, South Carolina 29401
    United States

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  • Dallas, Texas 75001
    United States

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  • Houston, Texas 77001
    United States

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  • Roanoke, Virginia 24001
    United States

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  • Milwaukee, Wisconsin 53201
    United States

    Site Not Available

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