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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01283594
First received: January 24, 2011
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the effect of SYN115 on dyskinesia [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To assess the effect of SYN115 on UPDRS scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To assess investigator and patient impressions of PD severity and change [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To assess the effect of SYN115 on non motor symptoms of PD [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To assess the safety and tolerability of SYN115 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • To assess the effects of SYN115 on daytime drowsiness, impulsive behavior, development of melanoma and suicidal ideation [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 420
Study Start Date: March 2011
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283594

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States
United States, California
Chicago, California, United States
La Jolla, California, United States
Loma Linda, California, United States
Los Angeles, California, United States
Oxnard, California, United States
San Francisco, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Connecticut
Manchester, Connecticut, United States
New Haven, Connecticut, United States
United States, Florida
Boca Raton, Florida, United States
Gainsville, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Weston, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Augusta, Georgia, United States
United States, Idaho
Boise, Idaho, United States
United States, Illinois
Springfield, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Iowa
Des Moines, Iowa, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Michigan
West Bloomfield, Michigan, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, New York
Comack, New York, United States
New York, New York, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
United States, Oklahoma
Tulsa, Oklahoma, United States
United States, Pennsylvania
Allentown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
United States, Virginia
Roanoke, Virginia, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Argentina
Buenos Aires, Argentina
Santa Fe, Argentina
Canada, Alberta
Edmonton, Alberta, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Canada, Ontario
Ottawa, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Quebec City, Quebec, Canada
Chile
Santiago, Chile
Valdivia, Chile
Romania
Brasov, Romania
Bucharest, Romania
Constanta, Romania
Mures, Romania
Timisoara, Romania
Ukraine
Dnipropetrovsk, Ukraine
Donetsk, Ukraine
Kiev, Ukraine
Lviv, Ukraine
Poltava, Ukraine
Vinnytsia, Ukraine
Zaporizhzhya, Ukraine
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Chair: Steve Bandak, MD Biotie Therapies Inc.
Study Director: Ann Neale, RN Biotie Therapies Inc.
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01283594     History of Changes
Other Study ID Numbers: SYN115-CL02
Study First Received: January 24, 2011
Last Updated: May 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dihydroxyphenylalanine
Levodopa
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014