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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 Pharma
ClinicalTrials.gov Identifier:
NCT01283594
First received: January 24, 2011
Last updated: May 2, 2014
Last verified: May 2014

January 24, 2011
May 2, 2014
March 2011
October 2012   (final data collection date for 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 ] [ Designated as safety issue: No ]
Assess efficacy of different doses of SYN115 for reducing the mean total hours of awake time per day spent in the off state [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01283594 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To assess the effect of SYN115 on dyskinesia [ Designated as safety issue: No ]
  • To assess the effect of SYN115 on UPDRS scores [ Designated as safety issue: No ]
  • To assess investigator and patient impressions of PD severity and change [ Designated as safety issue: No ]
  • To assess the effect of SYN115 on non motor symptoms of PD [ Designated as safety issue: No ]
  • To assess the safety and tolerability of SYN115 [ Designated as safety issue: Yes ]
  • To assess the effects of SYN115 on daytime drowsiness, impulsive behavior, development of melanoma and suicidal ideation [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
  • 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: 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
  • 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.

  • 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.

  • 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.

  • Experimental: Tozadenant (SYN115) 60 mg BID
    Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
    Interventions:
    • Drug: Tozadenant (SYN115) 60 mg BID
    • Drug: Levodopa (L-dopa)
  • Experimental: Tozadenant (SYN115) 120 mg BID
    Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
    Interventions:
    • Drug: Levodopa (L-dopa)
    • Drug: Tozadenant (SYN115) 120 mg BID
  • Experimental: Tozadenant (SYN115) 180 mg BID
    Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
    Interventions:
    • Drug: Levodopa (L-dopa)
    • Drug: Tozadenant (SYN115) 180 mg BID
  • Experimental: Tozadenant (SYN115) 240 mg BID
    Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
    Interventions:
    • Drug: Levodopa (L-dopa)
    • Drug: Tozadenant (SYN115) 240 mg BID
  • Placebo Comparator: Sugar Pill
    White-coated, modified-oval placebo tablets.
    Interventions:
    • Drug: Placebo
    • Drug: Levodopa (L-dopa)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
420
Not Provided
October 2012   (final data collection date for primary outcome measure)

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
Both
30 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Canada,   Chile,   Romania,   Ukraine
 
NCT01283594
SYN115-CL02
No
UCB Pharma
UCB Pharma
Not Provided
Study Chair: Steve Bandak, MD Biotie Therapies Inc.
Study Director: Ann Neale, RN Biotie Therapies Inc.
UCB Pharma
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP