NCT00605553

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2008

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 31, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

1.1 years

First QC Date

January 15, 2008

Last Update Submit

August 3, 2017

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    Before treatment and at the end of each treatment period

Secondary Outcomes (3)

  • Pittsburgh side effect scale

    Before, after the first dose and end of each treatment period

  • VAS for overall well being, dizziness/light-headedness, nausea/vomiting, mood anxiety

    Before, after the first dose and end of each treatment period

  • Measurement of motor symptoms of Parkinson's disease and tapping speed

    Before, after the first dose and end of each treatment period

Study Arms (2)

1

EXPERIMENTAL

Active medication Tozadenant 20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID

Drug: Tozadenant

2

PLACEBO COMPARATOR

Crossover from arm 1 to arm 2 with one week washout. One of the arms is placebo control

Drug: Placebo

Interventions

PlaceboDRUG

Placebo oral capsules Placebo for 7 days

2
TozadenantDRUG

20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID

Also known as: A2a antagonist, SYN115
1

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

  • Black KJ, Campbell MC, Dickerson W, Creech ML, Koller JM, Chung SC, Bandak SI: A randomized, double-blind, placebo-controlled cross-over trial of the adenosine 2a antagonist SYN115 in Parkinson disease. Neurology 74(9): A317, 2010.

    RESULT

  • Black KJ, Koller JM, Campbell MC, Gusnard DA, Bandak SI. Quantification of indirect pathway inhibition by the adenosine A2a antagonist SYN115 in Parkinson disease. J Neurosci. 2010 Dec 1;30(48):16284-92. doi: 10.1523/JNEUROSCI.2590-10.2010.

    PMID: 21123574RESULT

MeSH Terms

Conditions

Parkinson Disease

Interventions

tozadenant

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Steve Bandak, MB BS MRCP

    Synosia Therapeutics

    STUDY CHAIR

  • Ann Neale, RN

    Synosia Therapeutics

    STUDY DIRECTOR

  • Uwe Meya, MD

    Synosia Therapeutics

    STUDY CHAIR

  • Kevin J Black, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2008

First Posted

January 31, 2008

Study Start

April 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

August 8, 2017

Record last verified: 2017-08

Locations

US(1)