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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283594
• Other study ID #: SYN115-CL02
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 2011
• Est. completion date: October 2012

Study information

• Verified date: May 2014
• Source: Biotie Therapies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Tozadenant (SYN115) 60 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. Total daily doses include 60 mg BID.
• Placebo
White-coated, modified-oval placebo tablets.
• Levodopa (L-dopa)
One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.
• Tozadenant (SYN115) 120 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. Total daily doses include 120 mg BID.
• Tozadenant (SYN115) 180 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. Total daily doses include 180 mg BID.
• Tozadenant (SYN115) 240 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths. Total daily doses include 240 mg BID.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biotie Therapies Inc.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess efficacy of different doses of SYN115 for reducing the mean total hours of awake time per day spent in the off state		12 weeks
Secondary	To assess the effect of SYN115 on dyskinesia		12 weeks
Secondary	To assess the effect of SYN115 on UPDRS scores		12 weeks
Secondary	To assess investigator and patient impressions of PD severity and change		12 weeks
Secondary	To assess the effect of SYN115 on non motor symptoms of PD		12 weeks
Secondary	To assess the safety and tolerability of SYN115		12 weeks
Secondary	To assess the effects of SYN115 on daytime drowsiness, impulsive behavior, development of melanoma and suicidal ideation		12 weeks