STRIDE
** This study is active but closed to open recruitment **A long-term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multicenter study to evaluate the effect of Stalevo in patients with Parkinson's disease requiring initiation of levodopa therapy.
The Parkinson's Disease and Movement Disorders Center of Albany Medical Center is participating in this multi-center clinical research trial sponsored by Novartis/Orion Pharma. This is a Phase IIJB3 clinical trial which will enroll approximately 740 patients at 70 investigative sites the United States and Europe. The primary objective of the study is to evaluate if Stalevo (carbidopa/levodopa/entacapone) is superior to carbidopa/levodopa in time to onset of dyskinesias in Parkinson's disease patients requiring initiation of levodopa treatment.
Design of the study: Patients who have Parkinson's disease and have been determined to require the initiation of levodopa therapy will be randomized to either Stalevo or levodopa in a blinded fashion. Neither subjects nor investigators will be aware of the treatment assignment during this study. Subjects will have a 50% chance of receiving either one of the treatment assignments. There will be a screening period of approximately one week to determine the patient's eligibility for this study. Patients will be assigned to their treatment at the baseline visit and then they will be followed approximately every two weeks during a dose titration phase, which lasts approximately two months and then will be seen approximately every three months thereafter during the maintenance phase of this study, which will last up to two to three years. At study visits there will be multiple measures of Parkinson's disease functioning as well as safety monitoring in the form of EKG, blood testing and questions regarding side effects. The dose of study medication will be increased during the study according to a predetermined schedule. During the maintenance phase there will be an option for additional carbidopa/levodopa to be added at the investigator's discretion for symptom control.
Cost to subject: None. Participation in this study is voluntary and the study participants will not be charged for the study drug or any aspect of the research study.
Inclusion criteria: (1) Age 30-70 years; (2) A diagnosis of Parkinson's disease for no more than five years prior to entering the study; (3) The need for levodopa therapy; (4) Dopamine agonists, MAO-B inhibitors and anticholinergic medications will be allowed but the dose must be stable for at least four weeks prior to study entry.
Exclusion criteria: (1) The presence of motor fluctuations including wearing off and drug induced dyskinesia; (2) Exposure to levodopa for more than 30 days or within eight weeks prior to study entry; (3) Previous or current use of COMT inhibitor, amantadine or memantine; (4) History of dementia, psychosis, epilepsy, major depression or active cancer; (5) A history of melanoma, narrow angle glaucoma or pheochromocytoma.
