EMD 128130 for the Treatment of Parkinson's Disease

Inclusion 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.