Study to Evaluate SYN115 in Parkinson's Disease
This study has been completed.
Sponsor:
Biotie Therapies Inc.
Information provided by:
Biotie Therapies Inc.
ClinicalTrials.gov Identifier:
NCT00605553
First received: January 15, 2008
Last updated: December 3, 2009
Last verified: December 2009
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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 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 Biotie Therapies 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 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Active medication SYN115, either 60 mg or 20 mg followed by 1 wk washout
|
Drug: SYN115
60 mg BID or 20 mg BID
Other Name: A2a antagonist
|
|
Placebo Comparator: 2
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 | |
| St. Louis, Missouri, United States, 63110 | |
Sponsors and Collaborators
Biotie Therapies 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
No publications provided
| Responsible Party: | Steve Bandak, MB BS MRCP Chief Medical Officer, Synosia Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00605553 History of Changes |
| Other Study ID Numbers: | SYN115-CL01 |
| Study First Received: | January 15, 2008 |
| Last Updated: | December 3, 2009 |
| 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 May 23, 2013