Clinical Trial TitleINSIGHTS study: An open-label, randomized 26-week study comparing levodopa-carbidopa INteStInal gel (LCIG) THerapy to optimized medical treatment (OMT) on non-motor symptoms (NMS) in subjects with advanced Parkinson's disease.
Clinical Trial Protocol Description:
The purpose of this study is to find out how well the investigational drug known as levodopa carbidopa intestinal gel (LCIG) and its delivery system (through infusion) work to treat nonmotor symptoms (insomnia [inability to sleep], depression, anxiety) in patients with advanced Parkinson's disease compared to optimized medical treatment.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have Parkinson’s disease with non-motor symptoms.
- Are 30 years of age or older.
- Have Parkinson’s disease responsive to levodopa.
You will be excluded from the study if any of the following criteria apply to you:
- Have an unclear diagnosis of Parkinson’s disease (secondary parkinsonism).
- Have undergone neurosurgery for treatment of Parkinson’s disease.
- Have hypersensitivity to levodopa, carbidopa or radiopaque material.
This is a partial list of inclusion and exclusion criteria.