A Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of SYN115 as Adjunctive Therapy in Levodopa-treated Parkinson's Subjects With End of Dose Wearing Off
DescriptionThe purpose of this research study is to test the effect of SYN115 compared to placebo (a "sugar pill" that looks like SYN115 but does not include active drug) on movement during the "on" and "off" states as well as other symptoms that some patients with Parkinson's disease experience. This study will also look at whether or not patients with Parkinson's disease experience "side-effects" with SYN115.
PhasePhase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.
Inclusion and Exclusion Criteria
- Meet Parkinson's Disease (PD) diagnosis consistent with UK PD diagnostic criteria
- Meet Hoehn and Yahr PD stage
- Good response to levodopa
- Stable regimen of anti-parkinson medications
- Are able to complete a Parkinson's disease diary
- If of childbearing potential(male and female), use an acceptable method of birth control
- Able and willing to sign an IRB/IEC approved informed consent
- Able and willing to understand study requirements, follow study instructions, attend all visits and undergo all planned tests.
- Secondary or atypical Parkinson's
- Neurosurgical intervention for Parkinson's disease
- Treatment with apomorphine
- Treatment with anti-psychotic drugs
- Other abnormal findings on physical or neuro exam or history that in the opinion of the investigator would make subject unsuitable for the study or prejudice safety and efficacy evaluation
- MMSE less than 26
- Subjects with untreated or uncontrolled current episode of major depression
- Receipt of any anti-psychotic drugs greater than 1 month in the past 5 years or any exposure in past year (except for quetiapine at doses <100mg per day)
- Women pregnant or lactating
- History of hepatitis, cholangitis
- Untreated or uncontrolled hypothyroidism or hyperthyroidism
- Drops in blood pressure requiring medication to maintain blood pressure
- Any clinically significant out of range laboratory evaluations
- Known sensitivity to the study medication or its components
- Suicide ideation or type 4 or type 5 on the Columbia suicide severity rating scale
- Finding of malignant melanoma on full body skin exam
- Impulse disorder conditions
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.