We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01283594
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Biotie Therapies Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. This study will also look at whether or not patients with Parkinson's disease experience "side-effects" with SYN115.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Tozadenant (SYN115) 60 mg BID Drug: Placebo Drug: Levodopa (L-dopa) Drug: Tozadenant (SYN115) 120 mg BID Drug: Tozadenant (SYN115) 180 mg BID Drug: Tozadenant (SYN115) 240 mg BID Phase 2 Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : March 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Tozadenant (SYN115) 60 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
 Drug: Tozadenant (SYN115) 60 mg BID

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

Total daily doses include 60 mg BID.


Drug: Levodopa (L-dopa)
One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.
Other Name: L-dopa
Experimental: Tozadenant (SYN115) 120 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
 Drug: Levodopa (L-dopa)
One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.
Other Name: L-dopa

Drug: Tozadenant (SYN115) 120 mg BID

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

Total daily doses include 120 mg BID.
Experimental: Tozadenant (SYN115) 180 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
 Drug: Levodopa (L-dopa)
One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.
Other Name: L-dopa

Drug: Tozadenant (SYN115) 180 mg BID

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

Total daily doses include 180 mg BID.
Experimental: Tozadenant (SYN115) 240 mg BID
Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
 Drug: Levodopa (L-dopa)
One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.
Other Name: L-dopa

Drug: Tozadenant (SYN115) 240 mg BID

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

Total daily doses include 240 mg BID.
Placebo Comparator: Sugar Pill
White-coated, modified-oval placebo tablets.
 Drug: Placebo
White-coated, modified-oval placebo tablets.

Drug: Levodopa (L-dopa)
One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.
Other Name: L-dopa


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To assess the effect of SYN115 on dyskinesia [ Time Frame: 12 weeks ]
  2. To assess the effect of SYN115 on UPDRS scores [ Time Frame: 12 weeks ]
  3. To assess investigator and patient impressions of PD severity and change [ Time Frame: 12 weeks ]
  4. To assess the effect of SYN115 on non motor symptoms of PD [ Time Frame: 12 weeks ]
  5. To assess the safety and tolerability of SYN115 [ Time Frame: 12 weeks ]
  6. To assess the effects of SYN115 on daytime drowsiness, impulsive behavior, development of melanoma and suicidal ideation [ Time Frame: 12 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01283594


Locations
Show Show 61 study locations
Sponsors and Collaborators
Biotie Therapies Inc.
Investigators
Layout table for investigator information
Study Chair: Steve Bandak, MD Biotie Therapies Inc.
Study Director: Ann Neale, RN Biotie Therapies Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Biotie Therapies Inc.
ClinicalTrials.gov Identifier: NCT01283594    
Other Study ID Numbers: SYN115-CL02
First Posted: January 26, 2011    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: May 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
 Neurodegenerative Diseases
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs