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Parkinson's DiseasePhase 2/3NCT01283594

Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off

A Phase 2/3 study testing Tozadenant (SYN115) 60 mg BID, Levodopa (L-dopa) and Tozadenant (SYN115) 120 mg BID in people with Parkinson's Disease, run by Biotie Therapies Inc. at 61 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this research study is to test the effect of SYN115 compared to placebo (a "sugar pill" that looks like SYN115 but does not include active drug) on movement during the "on" and "off" states as well as other symptoms that some patients with Parkinson's disease experience. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Tozadenant (SYN115) 60 mg BID, Levodopa (L-dopa) and Tozadenant (SYN115) 120 mg BID
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
420 participants
Where
61 sitesin 6 countries
Study dates
Mar 2011to Oct 2012
Phase
Phase 2/3
Are there results?
None posted in the registry

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

  • Meet Parkinson's Disease (PD) diagnosis consistent with UK PD diagnostic criteria
  • Meet Hoehn and Yahr PD stage
  • Good response to levodopa
  • Stable regimen of anti-parkinson medications
  • Are able to complete a Parkinson's disease diary
  • If of childbearing potential(male and female), use an acceptable method of birth control
  • Able and willing to sign an IRB/IEC approved informed consent
  • Able and willing to understand study requirements, follow study instructions, attend all visits and undergo all planned tests.

Who cannot join

  • Secondary or atypical Parkinson's
  • Neurosurgical intervention for Parkinson's disease
  • Treatment with apomorphine
  • Treatment with anti-psychotic drugs
  • Other abnormal findings on physical or neuro exam or history that in the opinion of the investigator would make subject unsuitable for the study or prejudice safety and efficacy evaluation
  • MMSE less than 26
Show all 17Show fewer
  • Subjects with untreated or uncontrolled current episode of major depression
  • Receipt of any anti-psychotic drugs greater than 1 month in the past 5 years or any exposure in past year (except for quetiapine at doses <100mg per day)
  • Women pregnant or lactating
  • History of hepatitis, cholangitis
  • Untreated or uncontrolled hypothyroidism or hyperthyroidism
  • Drops in blood pressure requiring medication to maintain blood pressure
  • Any clinically significant out of range laboratory evaluations
  • Known sensitivity to the study medication or its components
  • Suicide ideation or type 4 or type 5 on the Columbia suicide severity rating scale
  • Finding of malignant melanoma on full body skin exam
  • Impulse disorder conditions

Trial locations and contacts

61 sites in 6 countries.

61 sites in 6 countries

United States40 sites

  • Study site

    Allentown, Pennsylvania, 18001

  • Study site

    Atlanta, Georgia, 30301

  • Study site

    Augusta, Georgia, 30901

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Birmingham, Alabama, 35005

  • Study site

    Boca Raton, Florida, 33427

  • Study site

    Boise, Idaho, 83701

  • Study site

    Charleston, South Carolina, 29401

  • Study site

    Cincinnati, Ohio, 41073

  • Study site

    Cleveland, Ohio, 44101

  • Study site

    Columbus, Ohio, 43004

  • Study site

    Commack, New York, 11725

  • Study site

    Dallas, Texas, 75001

  • Study site

    Denver, Colorado, 80014

  • Study site

    Des Moines, Iowa, 50047

  • Study site

    Durham, North Carolina, 27517

  • Study site

    Gainesville, Florida, 32601

  • Study site

    Houston, Texas, 77001

  • Study site

    Indianapolis, Indiana, 46077

  • Study site

    Kansas City, Kansas, 66012

  • Study site

    La Jolla, California, 92037

  • Study site

    Lexington, Kentucky, 40502

  • Study site

    Loma Linda, California, 92318

  • Study site

    Los Angeles, California, 90001

  • Study site

    Manchester, Connecticut, 06040

  • Study site

    Miami, Florida, 33101

  • Study site

    Milwaukee, Wisconsin, 53201

  • Study site

    Minneapolis, Minnesota, 55111

  • Study site

    New Haven, Connecticut, 06501

  • Study site

    New York, New York, 10001

  • Study site

    Oxnard, California, 93030

  • Study site

    Philadelphia, Pennsylvania, 19019

  • Study site

    Roanoke, Virginia, 24001

  • Study site

    San Francisco, California, 94016

  • Study site

    Springfield, Illinois, 62629

  • Study site

    Tampa, Florida, 33601

  • Study site

    Toledo, Ohio, 43460

  • Study site

    Tulsa, Oklahoma, 74008

  • Study site

    West Bloomfield, Michigan, 48302

  • Study site

    Weston, Florida, 33326

Other trials in United States

Ukraine7 sites

  • Study site

    Dnipropetrovsk

  • Study site

    Donetsk

  • Study site

    Kiev

  • Study site

    Lviv

  • Study site

    Poltava

  • Study site

    Vinnytsia

  • Study site

    Zaporizhzhya

Other trials in Ukraine

Canada5 sites

  • Study site

    Edmonton, Alberta

  • Study site

    Halifax, Nova Scotia

  • Study site

    Montreal, Quebec

  • Study site

    Ottawa, Ontario

  • Study site

    Québec, Quebec

Other trials in Canada

Romania5 sites

  • Study site

    Brasov

  • Study site

    Bucharest

  • Study site

    Constanța

  • Study site

    Târgu Mureş

  • Study site

    Timișoara

Other trials in Romania

Argentina2 sites

  • Study site

    Buenos Aires

  • Study site

    Santa Fe

Other trials in Argentina

Chile2 sites

  • Study site

    Santiago

  • Study site

    Valdivia

Other trials in Chile

About this study

Official title: A Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of SYN115 as Adjunctive Therapy in Levodopa-treated Parkinson's Subjects With End of Dose Wearing Off

The purpose of this research study is to test the effect of SYN115 compared to placebo (a "sugar pill" that looks like SYN115 but does not include active drug) on movement during the "on" and "off" states as well as other symptoms that some patients with Parkinson's disease experience. This study will also look at whether or not patients with Parkinson's disease experience "side-effects" with SYN115.

Being tested
Tozadenant (SYN115) 60 mg BID, Placebo, Levodopa (L-dopa), Tozadenant (SYN115) 120 mg BID, Tozadenant (SYN115) 180 mg BID
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tozadenant (SYN115) 60 mg BIDDrug

    Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.

    Total daily doses include 60 mg BID.

  • PlaceboDrug

    White-coated, modified-oval placebo tablets.

  • Levodopa (L-dopa)Drug

    Also called L-dopa

    One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.

  • Tozadenant (SYN115) 120 mg BIDDrug

    Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.

    Total daily doses include 120 mg BID.

  • Tozadenant (SYN115) 180 mg BIDDrug

    Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.

    Total daily doses include 180 mg BID.

  • Tozadenant (SYN115) 240 mg BIDDrug

    Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.

    Total daily doses include 240 mg BID.

Study groups in NCT01283594
Study groupRoleWhat they receive
Tozadenant (SYN115) 60 mg BIDExperimentalTozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Receives: Drug: Tozadenant (SYN115) 60 mg BID; Drug: Levodopa (L-dopa)
Tozadenant (SYN115) 120 mg BIDExperimentalTozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Receives: Drug: Levodopa (L-dopa); Drug: Tozadenant (SYN115) 120 mg BID
Tozadenant (SYN115) 180 mg BIDExperimentalTozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Receives: Drug: Levodopa (L-dopa); Drug: Tozadenant (SYN115) 180 mg BID
Tozadenant (SYN115) 240 mg BIDExperimentalTozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Receives: Drug: Levodopa (L-dopa); Drug: Tozadenant (SYN115) 240 mg BID
Sugar PillPlacebo comparatorWhite-coated, modified-oval placebo tablets.
Receives: Drug: Placebo; Drug: Levodopa (L-dopa)

What is being measured

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

  1. Assess efficacy of different doses of SYN115 for reducing the mean total hours of awake time per day spent in the off state

    Measured: 12 weeks

Secondary outcomes (6)

  1. To assess the effect of SYN115 on dyskinesia

    Measured: 12 weeks

  2. To assess the effect of SYN115 on UPDRS scores

    Measured: 12 weeks

  3. To assess investigator and patient impressions of PD severity and change

    Measured: 12 weeks

  4. To assess the effect of SYN115 on non motor symptoms of PD

    Measured: 12 weeks

  5. To assess the safety and tolerability of SYN115

    Measured: 12 weeks

  6. To assess the effects of SYN115 on daytime drowsiness, impulsive behavior, development of melanoma and suicidal ideation

    Measured: 12 weeks

Timeline

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

  1. First posted26 Jan 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionOct 2012
  4. Study completionOct 2012

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
420 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01283594
Sponsor's protocol ID
SYN115-CL02
Status last verified
May 2014
First submitted
24 Jan 2011
Last updated
17 Jan 2019
Results posted
No
Data monitoring committee
No

Publications

  • Hauser RA, Olanow CW, Kieburtz KD, Pourcher E, Docu-Axelerad A, Lew M, Kozyolkin O, Neale A, Resburg C, Meya U, Kenney C, Bandak S. Tozadenant (SYN115) in patients with Parkinson's disease who have motor fluctuations on levodopa: a phase 2b, double-blind, randomised trial. Lancet Neurol. 2014 Aug;13(8):767-76. doi: 10.1016/S1474-4422(14)70148-6. Epub 2014 Jul 6.

    PubMed 25008546

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Tozadenant (SYN115) 60 mg BID, Levodopa (L-dopa) and Tozadenant (SYN115) 120 mg BID in people with Parkinson's Disease, run by Biotie Therapies Inc. at 61 sites in 6 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 8 inclusion and 17 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: finished, as of the sponsor's last update on 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, Ukraine, Canada, Romania, Argentina and 1 more country. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Assess efficacy of different doses of SYN115 for reducing the mean total hours of awake time per day spent in the off state (time frame: 12 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 NCT01283594, which also lists 1 linked publication.

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 17 Jan 2019.

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