Trial record 2 of 3 for:    syn115

Study to Evaluate SYN115 in Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00605553
First received: January 15, 2008
Last updated: May 2, 2014
Last verified: May 2014

January 15, 2008
May 2, 2014
April 2008
May 2009   (final data collection date for primary outcome measure)
This is an exploratory study to evaluate effects of SYN115 in patients with PD, as determined by clinical and fMRI evaluation. The results of this initial study will help determine the range to be used in subsequent studies. [ Time Frame: Before treatment and at the end of each treatment period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00605553 on ClinicalTrials.gov Archive Site
  • Pittsburgh side effect scale [ Time Frame: Before, after the first dose and end of each treatment period ] [ Designated as safety issue: No ]
  • VAS for overall well being, dizziness/light-headedness, nausea/vomiting, mood anxiety [ Time Frame: Before, after the first dose and end of each treatment period ] [ Designated as safety issue: No ]
  • Measurement of motor symptoms of Parkinson's disease and tapping speed [ Time Frame: Before, after the first dose and end of each treatment period ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate SYN115 in Parkinson's Disease
A Randomized, Double-blind, Placebo Controlled, Two-way Cross-over Study to Explore the Effects of 7 Days of Dosing With SYN115 20 mg p.o. BID or 60 mg p.o. BID on Clinical and fMRI Response to Intravenous Levodopa in Patients With Mild to Moderate Parkinson's Disease

This is an exploratory study to evaluate if SYN115 has an effect on Parkinson's disease as measured by clinical symptoms and brain images using magnetic resonance imaging (MRI) when a function test is administered.

This is a randomized, double-blind, placebo-controlled, two-way crossover study in which each patient will act as their own control. Each patient enrolled will receive both SYN115 (20 mg or 60 mg) and placebo separated by a minimum of one week washout between periods. An adaptive design will be used to determine if SYN115 elicits effects relevant to PD in the fewest number of patients by performing interim analyses in successive cohorts of patients receiving 60 or 20 mg.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
  • Drug: Placebo

    Placebo oral capsules

    Placebo for 7 days

  • Drug: Tozadenant
    20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID
    Other Names:
    • A2a antagonist
    • SYN115
  • Experimental: 1
    Active medication Tozadenant 20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID
    Intervention: Drug: Tozadenant
  • Placebo Comparator: 2
    Crossover from arm 1 to arm 2 with one week washout. One of the arms is placebo control
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of Parkinson's disease
  • Hoen and Yahr stage 1-3
  • On stable dose of anti-parkinsons treatment for 30 days prior to screening
  • Age 40 to 75 years
  • Sign an IRB approved informed consent
  • Men and women agree to use adequate birth control
  • ECG measurements are within normal limits
  • Able to understand study requirements

Exclusion Criteria:

  • Secondary Parkinson's (drug induced or post stroke)
  • Received treatment with other investigational drug 30 days prior to study entry
  • Using disallowed medications
  • Significant neurological illness other than Parkinson's
  • IQ less than 70 on IQ test
  • MMSE score < or = 23
  • History of psychosis or on anti-psychotic medication
  • Current serious medical illness
  • History of substance abuse
  • History of head injury with loss of consciousness
  • History of brain surgery
  • Contraindications to MRI like claustrophobia, metal implants or other implantable devices
  • Abnormal liver function tests and/or hepatitis or cholangitis
  • Gilberts disease
  • Pregnant or nursing
  • Known hypersensitivity to SYN115
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00605553
SYN115-CL01
No
UCB Pharma
UCB Pharma
Not Provided
Study Chair: Steve Bandak, MB BS MRCP Synosia Therapeutics
Study Director: Ann Neale, RN Synosia Therapeutics
Study Chair: Uwe Meya, MD Synosia Therapeutics
Principal Investigator: Kevin J Black, MD Washington University School of Medicine
UCB Pharma
May 2014

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