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Idiopathic Parkinson's DiseasePhase 3TOZ-PDNCT02453386

Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients

A Phase 3 study testing tozadenant in people with Idiopathic Parkinson's Disease, run by Biotie Therapies Inc. at 71 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Idiopathic Parkinson's Disease
What is being tested?
tozadenant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
449 participants
Where
71 sitesin 7 countries
Study dates
Jul 2015to 12 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
  • 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

71 sites in 7 countries.

71 sites in 7 countries

United States40 sites

  • Study site

    Albany, New York, 12084

  • Study site

    Asheville, North Carolina, 28715

  • Study site

    Atlanta, Georgia, 30301

  • Study site

    Augusta, Georgia, 30805

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Birmingham, Alabama, 35005

  • Study site

    Boca Raton, Florida, 33428

  • Study site

    Boston, Massachusetts, 02101

  • Study site

    Burlington, Vermont, 05401

  • Study site

    Chicago, Illinois, 60007

  • Study site

    Cincinnati, Ohio, 41073

  • Study site

    Cleveland, Ohio, 44101

  • Study site

    Commack, New York, 11725

  • Study site

    Durham, North Carolina, 27517

  • Study site

    East Lansing, Michigan, 48808

  • Study site

    Englewood, Colorado, 80110

  • Study site

    Farmington Hills, Michigan, 48167

  • Study site

    Gainesville, Florida, 32601

  • Study site

    Houston, Texas, 77001

  • Study site

    Jacksonville, Florida, 32034

  • Study site

    Kansas City, Kansas, 66012

  • Study site

    Kirkland, Washington, 98033

  • Study site

    Lexington, Kentucky, 40502

  • Study site

    Loma Linda, California, 92318

  • Study site

    Los Angeles, California, 90001

  • Study site

    Nashville, Tennessee, 37011

  • Study site

    Oxnard, California, 93030

  • Study site

    Philadelphia, Pennsylvania, 19019

  • Study site

    Reseda, California, 91335

  • Study site

    Roanoke, Virginia, 24001

  • Study site

    Rochester, New York, 14602

  • Study site

    Sacramento, California, 914203

  • Study site

    St Louis, Missouri, 63101

  • Study site

    Sun City, Arizona, 85351

  • Study site

    Sunnyvale, California, 94043

  • Study site

    Tampa, Florida, 33601

  • Study site

    Toledo, Ohio, 43460

  • Study site

    Tulsa, Oklahoma, 74008

  • Study site

    Vernon, Connecticut, 06029

  • Study site

    West Bloomfield, Michigan, 48302

Other trials in United States

Italy9 sites

  • Study site

    Arcugnano

  • Study site

    Cassino

  • Study site

    Chieti

  • Study site

    Grosseto

  • Study site

    Pavia

  • Study site

    Pisa

  • Study site

    Rome

  • Study site

    Salerno

  • Study site

    Venice

Other trials in Italy

Germany6 sites

  • Study site

    Beelitz-Heilstätten

  • Study site

    Berlin

  • Study site

    Dresden

  • Study site

    Haag in Oberbayern

  • Study site

    Marburg

  • Study site

    Ulm

Other trials in Germany

Spain6 sites

  • Study site

    Barcelona

  • Study site

    Donostia / San Sebastian, Guipuzcoa

  • Study site

    Madrid

  • Study site

    Manresa, Barcelona

  • Study site

    Sant Cugat del Vallès, Barcelona

  • Study site

    Terrassa, Barcelona

Other trials in Spain

Czechia5 sites

  • Study site

    Brno

  • Study site

    Choceň

  • Study site

    Pardubice

  • Study site

    Prague

  • Study site

    Rychnov nad Kněžnou

Other trials in Czechia

Canada3 sites

  • Study site

    Edmonton, Alberta

  • Study site

    Ottawa, Ontario

  • Study site

    Toronto, Ontario

Other trials in Canada

Austria2 sites

  • Study site

    Innsbruck

  • Study site

    Vienna

Other trials in Austria

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study 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).

Read the 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.
Being tested
tozadenant, placebo
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

  • placeboDrug

    Also called tozadenant placebo

Study groups in NCT02453386
Study groupRoleWhat they receive
Tozadenant 60 mg BIDExperimentalDuring Part A, patients took 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.
Receives: Drug: tozadenant
Tozadenant 120 mg BIDExperimentalDuring Part A, patients took 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.
Receives: Drug: tozadenant
Placebo BIDPlacebo comparatorDuring Part A, patients took 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.
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Week 24 in the Number of Hours Per Day Spent in OFF Time

    Awake time in OFF state (hr) is the average of maximum of 3 days diary. The primary efficacy endpoint was the change from baseline to Week 24 in OFF time, where OFF time in the Hauser Parkinson's Disease Home Diary (PD) was averaged over 3 days prior to the study visit. During Screening and through Part A of the study, the Hauser Parkinson's Disease Home Diary (PD) was completed on specified days directly preceding the scheduled study visits/assessments. Motor activity was recorded as OFF, ON (mobility improved), or asleep time. Patients were asked to record ON time according to dyskinesia categories "without dyskinesia", "with non troublesome dyskinesia" or "with troublesome dyskinesia". Patients (and/or caregivers) were trained to complete the PD diary to record their status at half hourly intervals as OFF, ON without dyskinesia, ON with non troublesome dyskinesia, ON with troublesome dyskinesia, or asleep.

    Measured: Baseline to 24 Weeks

Secondary outcomes (3)

  1. Change in Good ON Time From Baseline to Week 24

    The first key secondary efficacy endpoint was the change from baseline to Week 24 in good ON which was defined as ON without dyskinesia or ON with non-troublesome dyskinesia.

    Awake Time in Good ON State (hr) is the average of a maximum of 3 days diary. Patients were asked to record ON time according to dyskinesia categories "without dyskinesia", "with non troublesome dyskinesia" or "with troublesome dyskinesia" . Patients (and/or caregivers) were trained to complete the PD diary to record their status at half hourly intervals as OFF, ON without dyskinesia, ON with non troublesome dyskinesia, ON with troublesome dyskinesia, or asleep. For patients with missing baseline or baseline was measured post-dose, screening was used as baseline in the calculation of change from baseline.

    Measured: Baseline to 24 Weeks

  2. Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Activities of Daily Living (ADL) Subscale + Part III Motor Function

    The Unified Parkinson's Disease Rating Scale (UPDRS) is a scale to monitor Parkinson's Disease related disability and impairment. The scale itself has 4 components are titled; (1) nonmotor experiences of daily living (13 items), (2) motor experiences of daily living (13 items), (3) motor examination (18 items), and (4) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. In this outcome measure we are evaluating Part II and Part III.

    Part II: self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food Part III: clinician-scored monitored motor evaluation Range of score is 0 - 160: 0 meaning less impact and Higher score indicates greater impact of PD symptoms.

    Measured: Baseline to Week 24

  3. Change From Baseline to Week 24 in the ON State in Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl

    Change from Baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS) Parts III Motor Function (motor subscale) total scores. Each subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Range of score is 0 - 108. Higher scores indicate greater impact of PD symptoms. Unified Parkinson's Disease Rating Scale (UPDRS) in the ON state was measured at a time representative of the ON state in that patient, not in "best" ON. Unified Parkinson's Disease Rating Scale Part III in OFF was not evaluated.

    Measured: Baseline to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2015 (estimated)
  2. Study startJul 2015
  3. Primary completion12 Jan 2018
  4. Study completion12 Jan 2018

Why it stopped: New Safety Information

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
449 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02453386
Sponsor's protocol ID
TOZ-CL05
Other IDs
2014-005630-60, 2014
Acronym
TOZ-PD
Status last verified
Mar 2019
First submitted
21 May 2015
Last updated
3 Apr 2019
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tozadenant in people with Idiopathic Parkinson's Disease, run by Biotie Therapies Inc. at 71 sites in 7 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 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Italy, Germany, Spain, Czechia and 2 more countries. 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. Some participants in this study may receive a placebo. 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 26 Mar 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?

Change From Baseline to Week 24 in the Number of Hours Per Day Spent in OFF Time (time frame: Baseline to 24 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02453386.

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 Apr 2019.

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