Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients
Status: | Terminated |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 30 - 80 |
Updated: | 4/5/2019 |
Start Date: | July 2015 |
End Date: | January 12, 2018 |
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose "Wearing-Off" (TOZ-PD)
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).
parallel-group, 3-arm safety and efficacy study (Part A) with an open-label phase (Part B).
During Part A, each patient will participate for up to 30 weeks, which includes a Screening
Period of 1 to ≤ 6 weeks, followed by a Baseline Visit and 24 weeks of double-blind
treatment:
- Screening Period: 1 - 6 weeks.
- Double-Blind Treatment Period: 24 weeks.
After completion of Part A, patients will continue in Part B for an additional 56 weeks:
- Open-Label Treatment Period: 52 weeks.
- Post-Treatment Safety Follow Up: 4 weeks.
Period of 1 to ≤ 6 weeks, followed by a Baseline Visit and 24 weeks of double-blind
treatment:
- Screening Period: 1 - 6 weeks.
- Double-Blind Treatment Period: 24 weeks.
After completion of Part A, patients will continue in Part B for an additional 56 weeks:
- Open-Label Treatment Period: 52 weeks.
- 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
- 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
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