JP-1730 to Treat Parkinson's Disease
Parkinson Disease
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring JP 1730, Dyskinesias, Levodopa Infusion, Apomorphine Infusion, Clinical Trial, Parkinson Disease, PD
Eligibility Criteria
INCLUSION CRITERIA: Patients who meet all of the following inclusion criteria at Day 0 will be eligible to participate in the study: Patient is between the ages of 30 and 80; Patient has an intact oral mucosa; Patient has been diagnosed with idiopathic Parkinson's disease based on the presence of a characteristic clinical history and neurologic findings; Patient has relatively advanced disease with levodopa-associated motor response complications, including peak-dose dyskinesias and wearing-off fluctuations; Patient is willing to adhere to protocol requirements as evidenced by written, informed consent. EXCLUSION CRITERIA: Patients meeting any of the following exclusion criteria either at Day 0 or during the study will not be enrolled or will be immediately excluded from the study, as appropriate: Patient has a history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk, including bronchospasm or lung disease, clinically significant cardiac arrhythmias and/or myocardial ischemia; baseline bundle branch block or QTc greater than 480 msec; Patient has clinically significant laboratory abnormalities including liver enzyme elevation greater than twice the upper limit of normal; Patient is unable to be treated with levodopa/carbidopa alone or with a single, relatively short-acting dopamine agonist, such as pramipaxole or ropinirole; Patient is taking a prohibited concomitant medication; Patient has not been using an adequate contraceptive method for the last 30 days, or is not at least one year post-menopausal (if female); Patient is pregnant or breastfeeding; Patient is implanted with bilateral deep brain stimulators; Patient has prior bilateral pallidotomy or other ablative surgeries for treatment of PD; Patient has cognitive impairment (MMSE less than 25); Patients with known history of chronic adrenal pituitary insufficiency, pituitary insufficiency, or clinically significant laboratory abnormalities suggestive of adrenal insufficiency, such as an elevated ACTH level; Patient has an obvious oral mucosa abnormality; Patient has participated in a clinical study with an investigational drug within the last 30 days; Patient has a condition (such as active drug or alcohol abuse) that, in the opinion of the investigators, would interfere with compliance or safety; Patient is unwilling to sign an informed consent or to comply with protocol requirements.
Sites / Locations
- National Institute of Neurological Disorders and Stroke (NINDS)