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Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease.

NCT03051607 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2019-05-03

Study results available
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Summary

Phase 3, international, multicenter, open-label 12 month safety study.

Conditions

  • Idiopathic Parkinson Disease

Interventions

DRUG

Tozadenant

1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted.

Sponsors & Collaborators

  • Acorda Therapeutics

    collaborator INDUSTRY

  • Biotie Therapies Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher Kenney, MD · Acorda Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-04-10
Primary Completion
2018-01-16
Completion
2018-01-16
FDA Drug
Yes

Countries

  • United States
  • Canada
  • United Kingdom

Study Locations

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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 NCT03051607 on ClinicalTrials.gov