Study to Evaluate SYN115 in Parkinson's Disease - Full Text View

Sponsored by:	Synosia Therapeutics, Inc.
Information provided by:	Synosia Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00605553

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: SYN115	Phase II

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Nausea and Vomiting Parkinson's Disease

Drug Information available for: Levodopa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Synosia Therapeutics, 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 ]

Estimated Enrollment:	32
Study Start Date:	April 2008
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Active medication SYN115, either 60 mg or 20 mg followed by 1 wk washout	Drug: SYN115 60 mg BID or 20 mg BID
2: Placebo Comparator Crossover from arm 1 to arm 2 with one week washout. One of the arms is placebo control	Drug: Placebo 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605553

Locations

United States, Missouri
Washington University St. Louis	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Mary Creech 314-362-7651 maryc@npg.wustl.edu
Contact: Kevin Black, MD 1-314-362-2470 kevin@npg.wustl.edu
Principal Investigator: Kevin Black, MD

Sponsors and Collaborators

Synosia Therapeutics, 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 St. Louis

More Information

Responsible Party:	Synosia Therapeutics ( Steve Bandak, MB BS MRCP Chief Medical Officer )
Study ID Numbers:	SYN115-CL01
Study First Received:	January 15, 2008
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00605553
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Levodopa
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009