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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tozadenant (SYN115) 60 mg BID
Placebo
Levodopa (L-dopa)
Tozadenant (SYN115) 120 mg BID
Tozadenant (SYN115) 180 mg BID
Tozadenant (SYN115) 240 mg BID
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

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 birth control
  • Able and willing to sign an IRB/IEC approved informed consent
  • Able and willing to understand study requirements, follow study instructions, attend all visits and undergo all planned tests.

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 of the investigator would make subject unsuitable for the study or prejudice safety and efficacy 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 any exposure 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Tozadenant (SYN115) 60 mg BID

Tozadenant (SYN115) 120 mg BID

Tozadenant (SYN115) 180 mg BID

Tozadenant (SYN115) 240 mg BID

Sugar Pill

Arm Description

Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.

Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.

Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.

Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.

White-coated, modified-oval placebo tablets.

Outcomes

Primary Outcome Measures

Assess efficacy of different doses of SYN115 for reducing the mean total hours of awake time per day spent in the off state

Secondary Outcome Measures

To assess the effect of SYN115 on dyskinesia
To assess the effect of SYN115 on UPDRS scores
To assess investigator and patient impressions of PD severity and change
To assess the effect of SYN115 on non motor symptoms of PD
To assess the safety and tolerability of SYN115
To assess the effects of SYN115 on daytime drowsiness, impulsive behavior, development of melanoma and suicidal ideation

Full Information

First Posted
January 24, 2011
Last Updated
January 14, 2019
Sponsor
Biotie Therapies Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01283594
Brief Title
Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off
Official Title
A Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of SYN115 as Adjunctive Therapy in Levodopa-treated Parkinson's Subjects With End of Dose Wearing Off
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (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
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.

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, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tozadenant (SYN115) 60 mg BID
Arm Type
Experimental
Arm Description
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Arm Title
Tozadenant (SYN115) 120 mg BID
Arm Type
Experimental
Arm Description
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Arm Title
Tozadenant (SYN115) 180 mg BID
Arm Type
Experimental
Arm Description
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Arm Title
Tozadenant (SYN115) 240 mg BID
Arm Type
Experimental
Arm Description
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
White-coated, modified-oval placebo tablets.
Intervention Type
Drug
Intervention Name(s)
Tozadenant (SYN115) 60 mg BID
Intervention Description
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. Total daily doses include 60 mg BID.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
White-coated, modified-oval placebo tablets.
Intervention Type
Drug
Intervention Name(s)
Levodopa (L-dopa)
Other Intervention Name(s)
L-dopa
Intervention Description
One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.
Intervention Type
Drug
Intervention Name(s)
Tozadenant (SYN115) 120 mg BID
Intervention Description
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. Total daily doses include 120 mg BID.
Intervention Type
Drug
Intervention Name(s)
Tozadenant (SYN115) 180 mg BID
Intervention Description
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. Total daily doses include 180 mg BID.
Intervention Type
Drug
Intervention Name(s)
Tozadenant (SYN115) 240 mg BID
Intervention Description
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. Total daily doses include 240 mg BID.
Primary Outcome Measure Information:
Title
Assess efficacy of different doses of SYN115 for reducing the mean total hours of awake time per day spent in the off state
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
To assess the effect of SYN115 on dyskinesia
Time Frame
12 weeks
Title
To assess the effect of SYN115 on UPDRS scores
Time Frame
12 weeks
Title
To assess investigator and patient impressions of PD severity and change
Time Frame
12 weeks
Title
To assess the effect of SYN115 on non motor symptoms of PD
Time Frame
12 weeks
Title
To assess the safety and tolerability of SYN115
Time Frame
12 weeks
Title
To assess the effects of SYN115 on daytime drowsiness, impulsive behavior, development of melanoma and suicidal ideation
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 birth control Able and willing to sign an IRB/IEC approved informed consent Able and willing to understand study requirements, follow study instructions, attend all visits and undergo all planned tests. 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 of the investigator would make subject unsuitable for the study or prejudice safety and efficacy 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 any exposure 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Bandak, MD
Organizational Affiliation
Biotie Therapies Inc.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ann Neale, RN
Organizational Affiliation
Biotie Therapies Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35005
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
City
Loma Linda
State/Province
California
ZIP/Postal Code
92318
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90001
Country
United States
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94016
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States
City
Manchester
State/Province
Connecticut
ZIP/Postal Code
06040
Country
United States
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06501
Country
United States
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33427
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32601
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33101
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33601
Country
United States
City
Weston
State/Province
Florida
ZIP/Postal Code
33326
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30301
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83701
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62629
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46077
Country
United States
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50047
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66012
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40502
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48302
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55111
Country
United States
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
41073
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44101
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43004
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43460
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74008
Country
United States
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18001
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19019
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75001
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77001
Country
United States
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24001
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201
Country
United States
City
Buenos Aires
Country
Argentina
City
Santa Fe
Country
Argentina
City
Edmonton
State/Province
Alberta
Country
Canada
City
Halifax
State/Province
Nova Scotia
Country
Canada
City
Ottawa
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Quebec City
State/Province
Quebec
Country
Canada
City
Santiago
Country
Chile
City
Valdivia
Country
Chile
City
Brasov
Country
Romania
City
Bucharest
Country
Romania
City
Constanta
Country
Romania
City
Timisoara
Country
Romania
City
Târgu-Mureş
Country
Romania
City
Dnipropetrovsk
Country
Ukraine
City
Donetsk
Country
Ukraine
City
Kiev
Country
Ukraine
City
Lviv
Country
Ukraine
City
Poltava
Country
Ukraine
City
Vinnytsia
Country
Ukraine
City
Zaporizhzhya
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
25008546
Citation
Hauser RA, Olanow CW, Kieburtz KD, Pourcher E, Docu-Axelerad A, Lew M, Kozyolkin O, Neale A, Resburg C, Meya U, Kenney C, Bandak S. Tozadenant (SYN115) in patients with Parkinson's disease who have motor fluctuations on levodopa: a phase 2b, double-blind, randomised trial. Lancet Neurol. 2014 Aug;13(8):767-76. doi: 10.1016/S1474-4422(14)70148-6. Epub 2014 Jul 6.
Results Reference
derived

Learn more about this trial

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

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