Study to Evaluate SYN115 in Parkinson's Disease

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

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.


Condition Intervention Phase
Parkinson's Disease
Drug: Placebo
Drug: Tozadenant
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: April 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Active medication Tozadenant 20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID
Drug: Tozadenant
20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID
Other Names:
  • A2a antagonist
  • SYN115
Placebo Comparator: 2
Crossover from arm 1 to arm 2 with one week washout. One of the arms is placebo control
Drug: Placebo

Placebo oral capsules

Placebo for 7 days


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00605553

Locations
United States, Missouri
Washington University St. Louis
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
UCB, Inc.
Investigators
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
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00605553     History of Changes
Other Study ID Numbers: SYN115-CL01
Study First Received: January 15, 2008
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

ClinicalTrials.gov processed this record on August 28, 2014