EMD 128130 for the Treatment of Parkinson's Disease
Parkinson's Disease
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Dyskinesias, L-Dopa Infusion, Clinical Trial, Motor Function, Psychosis, Parkinson's Disease
Eligibility Criteria
Males and females between the ages of 30-80. Females must be either at least one year post-menopausal, or using an adequate contraceptive method for at least one month prior to and during participation in this study. Patients will carry the diagnosis of idiopathic Parkinson's disease based on the presence of a characteristic clinical history and neurologic findings. Patients will have relatively advanced disease with levodopa-associated motor response complications, including peak-dose dyskinesias and wearing-off fluctuations. Patients with the presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk will be excluded. Patients with clinically significant laboratory abnormalities including liver enzyme elevations more than two times the upper limit of normal will be excluded. Patients who are unable to be treated with levodopa/carbidopa alone or with a single, relatively short-acting dopamine agonist will be excluded. Patients with a form of parkinsonism other than idiopathic PD will be excluded. Patients with unacceptable prior/concomitant medications will be excluded. No pregnant women. Female and male patients must be practicing effective means of birth control. Patients with prior bilateral surgical intervention for the treatment of parkinsonian symptoms, i.e. deep brain stimulation, pallidotomy, fetal tissue transplantation will be excluded. Patients at risk for hypotension, cardiac arrhythmia, and/or myocardial ischemia secondary to intravenous levodopa challenge will not be eligible. Patients with cognitive impairment (MMSE less than 25) will not be eligible. Patients with subnormal serum cortisol responses to acute ACTH stimulation will be excluded.
Sites / Locations
- National Institute of Neurological Disorders and Stroke (NINDS)