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Completed

NCT Number: NCT01283594

Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat 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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tozadenant (SYN115) 60 mg BID

Drug

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

Total daily doses include 60 mg BID.

Placebo

Drug

White-coated, modified-oval placebo tablets.

Levodopa (L-dopa)

Drug

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

Other names: L-dopa

Tozadenant (SYN115) 120 mg BID

Drug

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

Total daily doses include 120 mg BID.

Tozadenant (SYN115) 180 mg BID

Drug

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

Total daily doses include 180 mg BID.

Tozadenant (SYN115) 240 mg BID

Drug

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

Total daily doses include 240 mg BID.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Biotie Therapies Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 26, 2011
Registry last updated
Jan 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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