Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease.

NCT03051607 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: TOZ-CL06
• Study Type: interventional
• Target: 66
• Locations: 3 countries
• Sites: 35

Brief Summary

Phase 3, international, multicenter, open-label 12 month safety study.

Conditions

Idiopathic Parkinson Disease

Keywords

Motor Fluctuations; Off time; On time; Dyskinesia

Outcome Measures

Primary Outcomes (1)

• To Evaluate the Safety and Tolerability of Tozadenant in Levodopa-treated PD Patients Experiencing Motor Fluctuations.

  The primary objective of this study was to evaluate the safety and tolerability of tozadenant in levodopa-treated Parkinson's Disease (PD) patients experiencing motor fluctuations, based on assessment of treatment-emergent adverse events (TEAEs), vital signs, electrocardiograms (ECGs), and clinical laboratory tests. A total of 66 patients were enrolled in 27 study centers across 6 countries: USA, United Kingdom, Italy, Canada, Spain and Hungary, and were included in the Safety Set (SS).

  Up to 28 Weeks including safety follow-up visit.

Secondary Outcomes (3)

• To Evaluate the Effects of Tozadenant on the Occurrences of Daytime Drowsiness by Using the Epworth Sleepiness Scale.

  Up to 28 Weeks including safety follow-up visit.

• To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.

  Up to 28 Weeks including safety follow-up visit.

• To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)

  Up to 28 Weeks including safety follow-up visit.

Study Arms (1)

Tozadenant

EXPERIMENTAL

120 mg twice daily. At Week 2 or thereafter doses of 60 mg BID and 120 mg BID will be permitted.

Drug: Tozadenant

Interventions

Tozadenant DRUG

1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted.

Also known as: SYN115

Tozadenant

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotie Therapies Inc.: lead
• Acorda Therapeutics: collaborator

Study Sites (35)

Barrow Neurology Clinics, St. Joseph's Hospital and Medical Center, Dignity Health

Phoenix, Arizona, 85013, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 77215, United States

Location

Collaborative Neuroscience Network, LLC

Long Beach, California, 90802, United States

Location

USC, Keck School of Medicine

Los Angeles, California, 90089, United States

Location

SC3 Research Group

Pasadena, California, 91105, United States

Location

JEM Research Institute

Atlantis, Florida, 33462, United States

Location

Aventura Neurologic Associates

Aventura, Florida, 33180, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

Neurology Associates, P.A.

Maitland, Florida, 32751, United States

Location

Neurology Associates of Ormond Beach

Ormond Beach, Florida, 32174, United States

Location

Parkinson's Disease Treatment Center of SW Florida

Port Charlotte, Florida, 33980, United States

Location

Infinity Clinical Research

Sunrise, Florida, 33513, United States

Location

Hawaii Pacific Neuroscience

Honolulu, Hawaii, 96817, United States

Location

Unity Point Health

Des Moines, Iowa, 10034, United States

Location

Unity Point Health

Des Moines, Iowa, 50312, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Kentucky, Department of Neurology

Lexington, Kentucky, 40536, United States

Location

Henry Ford West Bloomfield Hospital

Bloomfield Hills, Michigan, 48322, United States

Location

Struthers Parkinson's Center

Golden Valley, Minnesota, 55416, United States

Location

Struthers Parkinson's Center

Golden Valley, Minnesota, 55427, United States

Location

The Robert and John M. Bendheim Parkinson and Movement Disorders Center

New York, New York, 10029, United States

Location

Asheville Neurology Specialists, PA

Asheville, North Carolina, 28806, United States

Location

Raleigh Neurology Associates

Raleigh, North Carolina, 27607, United States

Location

Movement Disorders Clinic of Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

Abington Neurological Associates

Willow Grove, Pennsylvania, 27607, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Virginia, Department of Neurology

Charlottesville, Virginia, 98034, United States

Location

Booth Gardner Parkinson's Care Center

Kirkland, Washington, 98034, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

Location

University of Wisconsin - Madison

Madison, Wisconsin, 53706, United States

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

The Walton Centre NHS Foundation Trust, Neuroscience Research Center

Liverpool, England, L9 7U, United Kingdom

Location

Newcastle University Clinical Ageing Research Unit (CARU)

Newcastle upon Tyne, England, NE4 5PL, United Kingdom

Location

The Queen Elizabeth University Hospital Department of Neurology

Glasgow, Scottland, G51 4TF, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease; Dyskinesias

Interventions

tozadenant

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Christopher Kenney, Senior Vice President - Medical Affairs
• Organization: Acorda Therapeutics

ckenney@acorda.com

9143265775

Study Officials

• Christopher Kenney, MD

  Acorda Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 13, 2017
• Study Start: April 10, 2017
• Primary Completion: January 16, 2018
• Study Completion: January 16, 2018
• Last Updated: May 3, 2019
• Results First Posted: May 3, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); GB (3); US (31)