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

NCT01283594 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2019-01-17

No results posted yet for this 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.

Conditions

Interventions

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.

DRUG

Placebo

White-coated, modified-oval placebo tablets.

DRUG

Levodopa (L-dopa)

One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.

DRUG

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.

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Biotie Therapies Inc.

    lead INDUSTRY

Principal Investigators

  • Steve Bandak, MD · Biotie Therapies Inc.

  • Ann Neale, RN · Biotie Therapies Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States
  • Argentina
  • Canada
  • Chile
  • Romania
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01283594 on ClinicalTrials.gov