Effects of Monoamine Reuptake Inhibitor NS2330 in Parkinson's Disease
Parkinson's Disease
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Clinical Trial, Dyskinesias, Levodopa Infusion, Parkinson's Disease
Eligibility Criteria
INCLUSION CRITERIA Male and Females are eligible for this study. Ages 18-75. Women must be at least one year post-menopausal or using an adequate contraceptive method for at least one month prior to and during participation in the study. All will carry the diagnosis of idiopathic Parkinson's disease based on the presence of a characteristic clinical history and neurologic findings. All will have relatively advanced disease with levodopa-associated motor response complications, including wearing-off fluctuations and peak-dose dyskinesias. EXCLUSION CRITERIA The presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk. Any clinically significant laboratory abnormalities including liver enzyme elevations more than twice the upper limit of normal, or neutropenia (wbc less than 4000). Patients with diphasic or end-of dose dyskinesias or disabling dystonia. Patients who are unable to be treated with levodopa/carbidopa alone or a single, relatively short-acting dopamine agonist. Patients with any form of Parkinsonism other than idiopathic PD or with a diagnosis of dementia or major psychiatric disorder. Individuals with mild to moderate depression will be sought for this study, unless their depressive disorder currently requires regular medical therapy. Patients who are on unacceptable prior/concomitant medications. Pregnant women Those who are not practicing effective birth control. Patients with prior bilateral neurosurgical intervention for the treatment of Parkinsonian symptoms, i.e. deep brain stimulation, pallidotomy, fetal tissue transplantation as well as patients at risk for symptomatic hypotension, cardiac arrhythmia, and/or myocardial ischemia secondary to intravenous levodopa challenge or NS2330 therapy. Patients who have taken an investigational drug within the last two months prior to randomization. Previous participation in any NS 2330 study.
Sites / Locations
- National Institute of Neurological Disorders and Stroke (NINDS)