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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)

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ClinicalTrials.gov Identifier: NCT02453386
Recruitment Status : Terminated (New Safety Information)
First Posted : May 25, 2015
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Biotie Therapies Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Idiopathic Parkinson's Disease Drug: tozadenant Drug: placebo Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 449 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : July 2015
Actual Primary Completion Date : January 12, 2018
Actual Study Completion Date : January 12, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

Arm Intervention/treatment
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.

Drug: tozadenant
Other Name: SYN115

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.

Drug: tozadenant
Other Name: SYN115

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.

Drug: placebo
Other Name: tozadenant placebo




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.


Other Outcome Measures:
  1. CGI-I [ Time Frame: Week 24 ]
    Clinical Global Impression - Improvement

  2. PGI-I [ Time Frame: Week 24 ]
    Patient Global Impression - Improvement

  3. UPDRS Part III [ Time Frame: Baseline to Week 24 ]
    United Parkinson's Disease Rating ScalePart III (motor subscale) total score

  4. CGI-S [ Time Frame: Baseline to Week 24 ]
    Clinical Global Impressions - severity of illness



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02453386


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Sponsors and Collaborators
Biotie Therapies Inc.
Investigators
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Study Director: Chris Kenney Biotie Inc.

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Responsible Party: Biotie Therapies Inc.
ClinicalTrials.gov Identifier: NCT02453386     History of Changes
Other Study ID Numbers: TOZ-CL05
First Posted: May 25, 2015    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: December 2017

Keywords provided by Biotie Therapies Inc.:
Motor fluctuations
Off time
On time
Dyskinesia

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs