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Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients Using Levodopa (TOZ-PD)

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by Biotie Therapies Inc.
Sponsor:
Information provided by (Responsible Party):
Biotie Therapies Inc.
ClinicalTrials.gov Identifier:
NCT02453386
First received: May 21, 2015
Last updated: December 16, 2016
Last verified: December 2016
May 21, 2015
December 16, 2016
July 2015
December 2017   (Final data collection date for primary outcome measure)
Number of hours per day spent in the OFF state [ Time Frame: Baseline to Week 24 ]
Assessed by patient-completed PD diaries and averaged over 3 consecutive days
Same as current
Complete list of historical versions of study NCT02453386 on ClinicalTrials.gov Archive Site
  • Number of hours per day spent in ON time without dyskinesia and ON time with non troublesome dyskinesia. [ Time Frame: Baseline to Week 24 ]
    Assessed by patient-completed PD diaries and averaged over 3 consecutive days
  • UPDRS Part II + Part III [ Time Frame: Baseline to Week 24 ]
    United Parkinson's Disease Rating Scale Parts II (ADL subscale) + III (motor subscale) total scores.
Same as current
  • CGI-I [ Time Frame: Week 24 ]
    Clinical Global Impression - Improvement
  • PGI-I [ Time Frame: Week 24 ]
    Patient Global Impression - Improvement
  • UPDRS Part III [ Time Frame: Baseline to Week 24 ]
    United Parkinson's Disease Rating ScalePart III (motor subscale) total score
  • CGI-S [ Time Frame: Baseline to Week 24 ]
    Clinical Global Impressions - severity of illness
Same as current
 
Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients Using Levodopa
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Phase 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).

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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Idiopathic Parkinson's Disease
  • Drug: tozadenant
    Other Name: SYN115
  • Drug: placebo
    Other Name: tozadenant placebo
  • Experimental: Tozadenant 60 mg BID

    During Part A, patients will take two (2) tablets, one 60 mg tozadenant and one placebo, by mouth BID for a total of four (4) tablets per day.

    Upon completion of Part A, all patients will begin dosing with open label tozadenant in Part B.

    Intervention: Drug: tozadenant
  • Experimental: Tozadenant 120 mg BID

    During Part A, patients will take two (2) tablets of 60 mg tozadenant, by mouth BID for a total of four (4) tablets per day.

    Upon completion of Part A, all patients will begin dosing with open label tozadenant in Part B.

    Intervention: Drug: tozadenant
  • Placebo Comparator: Placebo BID

    During Part A, patients will take two (2) tablets of placebo, by mouth BID for a total of four (4) tablets per day.

    Upon completion of Part A, all patients will begin dosing with open label tozadenant in Part B.

    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
Not Provided
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years to 80 Years   (Adult, Senior)
No
Contact: Chris Kenney, MD christopher.kenney@biotie.com
Austria,   Canada,   Czech Republic,   Germany,   Italy,   Spain,   United States
 
 
NCT02453386
TOZ-CL05
Yes
Not Provided
Not Provided
Biotie Therapies Inc.
Biotie Therapies Inc.
Not Provided
Not Provided
Biotie Therapies Inc.
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP