Trial record 1 of 3 for: syn115

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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Biotie Therapies Inc.

ClinicalTrials.gov Identifier:

NCT01283594

First received: January 24, 2011

Last updated: February 14, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 24, 2011

Last Updated Date

February 14, 2013

Start Date ^ICMJE

March 2011

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Assess efficacy of different doses of SYN115 for reducing the mean total hours of awake time per day spent in the off state [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01283594 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess the effect of SYN115 on dyskinesia [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To assess the effect of SYN115 on UPDRS scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To assess investigator and patient impressions of PD severity and change [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To assess the effect of SYN115 on non motor symptoms of PD [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To assess the safety and tolerability of SYN115 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
To assess the effects of SYN115 on daytime drowsiness, impulsive behavior, development of melanoma and suicidal ideation [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

To assess the effect of SYN115 on dyskinesia [ Designated as safety issue: No ]
To assess the effect of SYN115 on UPDRS scores [ Designated as safety issue: No ]
To assess investigator and patient impressions of PD severity and change [ Designated as safety issue: No ]
To assess the effect of SYN115 on non motor symptoms of PD [ Designated as safety issue: No ]
To assess the safety and tolerability of SYN115 [ Designated as safety issue: Yes ]
To assess the effects of SYN115 on daytime drowsiness, impulsive behavior, development of melanoma and suicidal ideation [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Parkinson's Disease

Intervention ^ICMJE

Drug: Tozadenant (SYN115)

Study Arm (s)

Experimental: Tozadenant (SYN115) 60mg BID
Intervention: Drug: Tozadenant (SYN115)
Experimental: Tozadenant (SYN115) 120mg BID
Intervention: Drug: Tozadenant (SYN115)
Experimental: Tozadenant (SYN115) 180mg BID
Intervention: Drug: Tozadenant (SYN115)
Experimental: Tozadenant (SYN115) 240 mg BID
Intervention: Drug: Tozadenant (SYN115)
Placebo Comparator: Sugar Pill
Intervention: Drug: Tozadenant (SYN115)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

420

Completion Date

Not Provided

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Canada, Chile, Romania, Ukraine

Administrative Information

NCT Number ^ICMJE

NCT01283594

Other Study ID Numbers ^ICMJE

SYN115-CL02

Has Data Monitoring Committee

Responsible Party

Biotie Therapies Inc.

Study Sponsor ^ICMJE

Biotie Therapies Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:	Steve Bandak, MD	Biotie Therapies Inc.
Study Director:	Ann Neale, RN	Biotie Therapies Inc.

Information Provided By

Biotie Therapies Inc.

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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