Idiopathic Parkinson DiseasePhase 3NCT03051607
Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease.
A Phase 3 study testing Tozadenant in people with Idiopathic Parkinson Disease, run by Biotie Therapies Inc. at 35 sites in 3 countries.
Trial summary
Phase 3, international, multicenter, open-label 12 month safety study. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Idiopathic Parkinson Disease
- What is being tested?
- Tozadenant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 35 sitesin 3 countries
- Study dates
- 10 Apr 2017to 16 Jan 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
35 sites in 3 countries.
35 sites in 3 countries
United States31 sites
Asheville Neurology Specialists, PA
Asheville, North Carolina, 28806
JEM Research Institute
Atlantis, Florida, 33462
Aventura Neurologic Associates
Aventura, Florida, 33180
Henry Ford West Bloomfield Hospital
Bloomfield Hills, Michigan, 48322
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
University of Virginia, Department of Neurology
Charlottesville, Virginia, 98034
Unity Point Health
Des Moines, Iowa, 10034
Unity Point Health
Des Moines, Iowa, 50312
Struthers Parkinson's Center
Golden Valley, Minnesota, 55416
Struthers Parkinson's Center
Golden Valley, Minnesota, 55427
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
Baylor College of Medicine
Houston, Texas, 77030
University of Kansas Medical Center
Kansas City, Kansas, 66160
Booth Gardner Parkinson's Care Center
Kirkland, Washington, 98034
University of Kentucky, Department of Neurology
Lexington, Kentucky, 40536
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 77215
Collaborative Neuroscience Network, LLC
Long Beach, California, 90802
USC, Keck School of Medicine
Los Angeles, California, 90089
University of Wisconsin-Madison
Madison, Wisconsin, 53705
University of Wisconsin - Madison
Madison, Wisconsin, 53706
Neurology Associates, P.A.
Maitland, Florida, 32751
The Robert and John M. Bendheim Parkinson and Movement Disorders Center
New York, New York, 10029
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174
SC3 Research Group
Pasadena, California, 91105
Barrow Neurology Clinics, St. Joseph's Hospital and Medical Center, Dignity Health
Phoenix, Arizona, 85013
Parkinson's Disease Treatment Center of SW Florida
Port Charlotte, Florida, 33980
Raleigh Neurology Associates
Raleigh, North Carolina, 27607
Premier Clinical Research
Spokane, Washington, 99202
Infinity Clinical Research
Sunrise, Florida, 33513
Movement Disorders Clinic of Oklahoma
Tulsa, Oklahoma, 74136
Abington Neurological Associates
Willow Grove, Pennsylvania, 27607
United Kingdom3 sites
The Queen Elizabeth University Hospital Department of Neurology
Glasgow, Scottland, G51 4TF
The Walton Centre NHS Foundation Trust, Neuroscience Research Center
Liverpool, England, L9 7U
Newcastle University Clinical Ageing Research Unit (CARU)
Newcastle upon Tyne, England, NE4 5PL
About this study
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"
Phase 3, international, multicenter, open-label 12 month safety study.
Read the detailed description
Each patient will participate for up to 52 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.
- Conditions
- Idiopathic Parkinson Disease
- Being tested
- Tozadenant
- Keywords
- Motor Fluctuations, Off time, On time, Dyskinesia
- Medical subject headings
- Parkinson Disease, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TozadenantDrug
Also called SYN115
1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted.
| Study group | Role | What they receive |
|---|---|---|
| Tozadenant | Experimental | 120 mg twice daily. At Week 2 or thereafter doses of 60 mg BID and 120 mg BID will be permitted. Receives: Drug: Tozadenant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a short questionnaire. Minimum range is 0 - Maximum range is 24. A score within the range 0-9 is considered to be normal while a score within the range of 10-24 would indicate that medical help should be solicited.
Measured: 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.
The Columbia Suicide Severity Rating Scale (C-SSRS) is a standardized suicidality rating system. The interview measures presence of suicidality and consists of 4 categories: suicidal ideation, intensity of ideation, suicidal behavior, and actual/potential lethality.
Suicidal Ideation - A series of 1 -5 questions with 5 types of ideation of increasing severity. Score of Yes = 1, No= 0. A positive answer to question 4 (active suicidal ideation with some intent to act) or 5 (active suicidal ideation with specific plan and intent) indicates that the individual has some intent to act on suicidal thoughts and will need further evaluation.
Suicidal Behavior - Different types of suicidal behavior are scored (Yes=1, No=0) and identify the occurrence of actual, interrupted, or aborted attempts; preparatory behaviors; and suicide. The total number of each type of suicidal behavior show the density of suicide, (more behaviors represent a higher degree of risk).
Measured: 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)
The Minnesota Impulsive Disorders Interview (MIDI) 8 is a global instrument that includes questions for compulsive gambling, buying, and sexual behavior (as well as other disorders not reported to occur in PD).
The mMIDI consists of 5 modules: compulsive buying, compulsive gambling, compulsive eating, hypersexuality and punding.
Positive Answer: Any answer other than "no" on any question is considered a "yes"/positive answer.
Negative Module: A module is considered negative if the patient's answer to a gateway (initial) question is "no" or if a patient answers "yes" to a gateway question and "no" to all of the remaining answers after the gateway question in that module.
Positive Module: A module is considered positive if a patient gives a positive answer (No = 0, rarely = 1, occasionally = 2, frequently = 3) to any question after the gateway (initial) question in one or more of the 5 modules.
Measured: Up to 28 Weeks including safety follow-up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start10 Apr 2017
- Primary completion16 Jan 2018
- Study completion16 Jan 2018
Why it stopped: New Safety Information
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotie Therapies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Acorda Therapeutics
- Responsible party
- Sponsor
- Investigators
- Christopher Kenney, MD, Study director, Acorda Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051607
- Sponsor's protocol ID
- TOZ-CL06
- Status last verified
- Apr 2019
- First submitted
- 9 Feb 2017
- Last updated
- 3 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT03051607
- Acronym / sponsor ID
- TOZ-CL06
- Conditions
- Idiopathic Parkinson Disease
- Keywords
- Motor Fluctuations, Off time, On time, Dyskinesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New Safety Information
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Biotie Therapies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Acorda Therapeutics
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 16 Jan 2018 (actual)
- Study completion
- 16 Jan 2018 (actual)
- First posted
- 13 Feb 2017 (actual)
- Results
- Posted 3 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 3, international, multicenter, open-label 12 month safety study.
Detailed description
Each patient will participate for up to 52 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tozadenant | Experimental | Drug: Tozadenant120 mg twice daily. At Week 2 or thereafter doses of 60 mg BID and 120 mg BID will be permitted. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TozadenantAlso: SYN1151 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted. | Drug | Tozadenant |
Primary outcome
To Evaluate the Safety and Tolerability of Tozadenant in Levodopa-treated PD Patients Experiencing Motor Fluctuations.
Time frame: Up to 28 Weeks including safety follow-up visit.
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).
3 secondary outcomes
To Evaluate the Effects of Tozadenant on the Occurrences of Daytime Drowsiness by Using the Epworth Sleepiness Scale.
Time frame: 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.
Time frame: 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)
Time frame: Up to 28 Weeks including safety follow-up visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Parkinson Disease
Not yet recruitingObservational study
Longitudinal Observation of Neurodegeneration in Parkinson's Disease Using Molecular Imaging and Blood Biomarkers
Idiopathic Parkinson Disease
Not yet recruiting
Non-invasive Vagus Nerve Stimulation for Parkinson's Disease
Idiopathic Parkinson Disease
RecruitingPhase 2
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Parkinson Disease, Parkinson
Recruiting
MediPD: An Online Mediterranean Diet Program for People Living With Parkinson's Disease
Parkinson Disease, Idiopathic
Recruiting
Ginger-PD: Ginger as a Modifier of Ghrelin Levels and Gut Function in Parkinson's Disease
REM Sleep Behavior Disorder, Parkinson s Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Kenney, MD study director
Acorda Therapeutics
35 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tozadenant in people with Idiopathic Parkinson Disease, run by Biotie Therapies Inc. at 35 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, United Kingdom, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Evaluate the Safety and Tolerability of Tozadenant in Levodopa-treated PD Patients Experiencing Motor Fluctuations. (time frame: Up to 28 Weeks including safety follow-up visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.