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Trial record 3 of 8 for:    syn115

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"

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ClinicalTrials.gov Identifier: NCT03051607
Recruitment Status : Terminated (New Safety Information)
First Posted : February 13, 2017
Last Update Posted : January 19, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Phase 3, international, multicenter, open-label 12 month safety study.

Condition or disease Intervention/treatment Phase
Idiopathic Parkinson Disease Drug: Tozadenant Phase 3

Detailed Description:

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Eligible patients will begin dosing with tozadenant at a dose of 120 mg twice daily. At Week 2 or thereafter, the investigator may adjust the patient's IMP dose as clinically indicated; doses of 60 mg BID and 120 mg BID will be permitted.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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"
Actual Study Start Date : April 10, 2017
Primary Completion Date : January 16, 2018
Study Completion Date : January 16, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Tozadenant
120 mg twice daily. At Week 2 or thereafter doses of 60 mg BID and 120 mg BID will be permitted.
Drug: Tozadenant
1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted.
Other Name: SYN115


Outcome Measures

Primary Outcome Measures :
  1. Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 12 months ]
    To evaluate the safety and tolerability of tozadenant in levodopa-treated Parkinson's Disease (PD) patients experiencing motor fluctuations, based on number subjects with TEAEs

  2. Vital Signs [ Time Frame: 12 months ]
    To evaluate the safety and tolerability of tozadenant in levodopa-treated PD patients experiencing motor fluctuations, based on changes in blood pressure and heart rate during treatment, including changes in orthostatic response

  3. Electrocardiograms (ECGs) [ Time Frame: 12 months ]
    To evaluate the safety and tolerability of tozadenant in levodopa-treated PD patients experiencing motor fluctuations, based on changes on ECG recordings of the RR, PR, QRS, QT and QTcF intervals.

  4. Clinical Laboratory Tests [ Time Frame: 12 months ]
    To evaluate the safety and tolerability of tozadenant in levodopa-treated PD patients experiencing motor fluctuations, based on changes in clinical chemistry, hematology and urine samples


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
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 (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
Contacts and Locations

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): NCT03051607


  Show 35 Study Locations
Sponsors and Collaborators
Biotie Therapies Inc.
Acorda Therapeutics
Investigators
Study Director: Antero Kallio Biotie Therapies Corp.
More Information

Responsible Party: Biotie Therapies Inc.
ClinicalTrials.gov Identifier: NCT03051607     History of Changes
Other Study ID Numbers: TOZ-CL06
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
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