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

Stopped early · Phase 3

Conditions studied: Idiopathic Parkinson Disease

In brief

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

Key facts

Study ID

NCT03051607

Run by

Biotie Therapies Inc.

People needed

66

Starts

2017-04-10

Expected to finish

2018-01-16

Last updated by the study team

2019-05-03

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 (except DBS if electrode placement has been performed over 12 months prior to screening)
• 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

• Barrow Neurology Clinics, St. Joseph's Hospital and Medical Center, Dignity Health — Phoenix, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Collaborative Neuroscience Network, LLC — Long Beach, California, United States
• USC, Keck School of Medicine — Los Angeles, California, United States
• SC3 Research Group — Pasadena, California, United States
• JEM Research Institute — Atlantis, Florida, United States
• Aventura Neurologic Associates — Aventura, Florida, United States
• Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States
• Neurology Associates, P.A. — Maitland, Florida, United States
• Neurology Associates of Ormond Beach — Ormond Beach, Florida, United States
• Parkinson's Disease Treatment Center of SW Florida — Port Charlotte, Florida, United States
• Infinity Clinical Research — Sunrise, Florida, United States
• Hawaii Pacific Neuroscience — Honolulu, Hawaii, United States
• Unity Point Health — Des Moines, Iowa, United States
• Unity Point Health — Des Moines, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Kentucky, Department of Neurology — Lexington, Kentucky, United States
• Henry Ford West Bloomfield Hospital — Bloomfield Hills, Michigan, United States
• Struthers Parkinson's Center — Golden Valley, Minnesota, United States
• Struthers Parkinson's Center — Golden Valley, Minnesota, United States
• The Robert and John M. Bendheim Parkinson and Movement Disorders Center — New York, New York, United States
• Asheville Neurology Specialists, PA — Asheville, North Carolina, United States
• Raleigh Neurology Associates — Raleigh, North Carolina, United States
• Movement Disorders Clinic of Oklahoma — Tulsa, Oklahoma, United States
• Abington Neurological Associates — Willow Grove, Pennsylvania, United States

Full record on ClinicalTrials.gov

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