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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00605553 |
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Date of registration:
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15/01/2008 |
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Primary sponsor: |
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Public title:
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Study to Evaluate SYN115 in Parkinson's Disease
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Scientific title:
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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 |
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Date of first enrolment:
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April 2008 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00605553 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Ann Neale, RN |
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Address:
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Telephone:
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Email:
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Affiliation:
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Synosia Therapeutics |
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Name:
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Steve Bandak, MB BS MRCP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Synosia Therapeutics |
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Name:
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Uwe Meya, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Synosia Therapeutics |
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Name:
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Kevin J Black, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Washington University, St. Louis |
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Placebo
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Drug: SYN115
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Measurement of motor symptoms of Parkinson's disease and tapping speed
[Time Frame: Before, after the first dose and end of each treatment period]
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Pittsburgh side effect scale
[Time Frame: Before, after the first dose and end of each treatment period]
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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]
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Secondary ID(s)
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SYN115-CL01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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