A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson’s Subjects Receiving Optimized Treatments with Parkinson Medicinal Products

Study Number: 
S187.3.002
Topic: 
Parkinson's Disease - Fluctuators
Pricipal Investigator: 
Alberto J Espay
Ongoing: 
Ongoing
Place: 
Medical Arts Building
Overview: 

The objective of this study is to demonstrate the superiority of levodopa-carbidopa intestinal gel over treatment with optimized oral levodopa-carbidopa during 12 weeks. Extension protocols will be available for patients to continue treatment.

Qualifications: 

Subjects with PD are eligible to participate if they meet the following criteria: levodopa-responsive with identifiable “on response” and severe motor fluctuations in spite of optimized treatment, >30 years of age, minimum “off” time 3 hrs per day, MMSE > 24. Subjects must not have other Parkinsonian syndromes and must not have undergone surgery for treatment of PD.

Contact: 

For more information, please contact Michele Janszen, at michele.janszen@uc.edu or (513) 558-0125.