A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose "Wearing-Off"
Status: | Terminated |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 30 - 80 |
Updated: | 1/21/2018 |
Start Date: | April 10, 2017 |
End Date: | January 16, 2018 |
Phase 3, international, multicenter, open-label 12 month safety study.
Each patient will participate for up to 62 weeks, which includes a Screening Period, followed
by a Baseline Visit and open-label treatment for 1 year with a safety Follow-up 4 weeks after
the last treatment.
- Screening Period: up to 6 weeks.
- Open-Label Treatment Period: 52 weeks (1 year)
- Post-Treatment Safety Follow Up: 4 weeks.
by a Baseline Visit and open-label treatment for 1 year with a safety Follow-up 4 weeks after
the last treatment.
- Screening Period: up to 6 weeks.
- Open-Label Treatment Period: 52 weeks (1 year)
- Post-Treatment Safety Follow Up: 4 weeks.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
29
sites
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
6701 Country Club Drive
Golden Valley, Minnesota 55427
Golden Valley, Minnesota 55427
888-993-5495

Principal Investigator: Martha Nance, MD
Phone: 952-993-5903
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1200 Moursund Street
Houston, Texas 77030
Houston, Texas 77030
(713) 798-4951

Phone: 713-798-3951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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529 West Markham Street
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
(501) 686-7000

Principal Investigator: Rohit Dhall, MD
Phone: 501-526-7665
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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8 Mirror Lake Dr # A
Ormond Beach, Florida 32174
Ormond Beach, Florida 32174
Phone: 386-676-6340
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6000 University Avenue
Des Moines, Iowa 50266
Des Moines, Iowa 50266
Principal Investigator: Lynn Struck, MD
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3901 Rainbow Blvd
Kansas City, Kansas 66160
Kansas City, Kansas 66160
(913) 588-5000

Phone: 913-588-0013
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Long Beach, California 90806
Principal Investigator: Omid Omidvar, MD
Phone: 844-909-3939
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Madison, Wisconsin 53706
(608) 263-2400

Principal Investigator: Kathleen Shannon, MD
Phone: 608-262-7115
University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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5 East 98th Street
New York, New York 10029
New York, New York 10029
Phone: 212-241-5607
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350 West Thomas Road
Phoenix, Arizona 85013
Phoenix, Arizona 85013
Phone: 602-406-3719
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7302 South Yale Avenue
Tulsa, Oklahoma 74136
Tulsa, Oklahoma 74136
Phone: 918-392-4530
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