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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Idiopathic Parkinson's Disease

In brief

Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 3-arm safety and efficacy study (Part A) with an open-label phase (Part B).

Key facts

Study ID

NCT02453386

Run by

Biotie Therapies Inc.

People needed

449

Starts

2015-07-01

Expected to finish

2018-01-12

Last updated by the study team

2019-04-03

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient understands study requirements and has given his/her written informed consent on an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved consent form.
• Parkinson's disease diagnosis consistent with UK Parkinson's Disease Society Brain Bank Diagnostic criteria
• Minimum of 3 years since diagnosis.
• Meet Hoehn and Yahr PD stage
• Good response to levodopa
• Stable regimen of anti-PD medications
• Patients must have been taking a levodopa-containing anti-PD medication continuously for at least the previous 12 months
• Patient has documented a minimum amount of Off time.
• If of childbearing potential (male and female) must use an acceptable method of contraception

You may not qualify if…

• Previous tozadenant study participation
• Current or recent participation in another study.
• Secondary or atypical parkinsonism
• Neurosurgical intervention for PD
• Patient is taking apomorphine, budipine, istradefylline, tolcapone, or DUOPA™/Duodopa®
• Treatment with excluded medications
• Untreated or uncontrolled hyperthyroidism or hypothyroidism
• Clinically significant out-of-range laboratory
• MMSE out of range
• Current episode of major depression (stable treatment for depression is permitted).
• Recent suicide attempt or suicidal ideation type 4 or type 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS)
• Women lactating or pregnant
• Hypersensitivity to any components of tozadenant or excipients
• Abnormal findings on the physical or neurological examination, or medical history that would make the patient unsuitable for the study
• History of hepatitis or cholangitis

Where it is running

• Study site — Sun City, Arizona, United States
• Study site — Loma Linda, California, United States
• Study site — Los Angeles, California, United States
• Study site — Oxnard, California, United States
• Study site — Reseda, California, United States
• Study site — Sacramento, California, United States
• Study site — Sunnyvale, California, United States
• Study site — Englewood, Colorado, United States
• Study site — Vernon, Connecticut, United States
• Study site — Boca Raton, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Augusta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Kansas City, Kansas, United States
• Study site — Lexington, Kentucky, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — East Lansing, Michigan, United States
• Study site — Farmington Hills, Michigan, United States
• Study site — West Bloomfield, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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