Patient- and Caregiver-reported Symptoms and Outcomes With Levodopa/Carbidopa Intestinal Gel for the Treatment of Advanced Parkinson's Disease

Study on Patient- and Caregiver-reported Symptoms and Outcomes With Levodopa/Carbidopa Intestinal Gel for the Treatment of Advanced Parkinson's Disease

Patient reported outcomes (PRO) have become an important endpoint assessed in clinical trials. It is important to understand the relationship between medication and patients' symptomatology, quality of life and well-being. We predict levodopa/carbidopa intestinal gel (LCIG; Duodopa) will significantly improve quality of life and emotional well-being compared to baseline in patients with advance Parkinson disease (APD) not well controlled with conventional treatment.

Inclusion Criteria:

• Patients with advanced levodopa-responsive Parkinson's disease, with at least, 2 hours "off" time or 2 hours of dyskinesia based on clinician's/investigator's medical judgment
• Patients with advanced Parkinson's disease with severe motor fluctuations and dyskinesia when combination of conventional PD treatments was unable to satisfactory control symptoms.
• Patients with advanced Parkinson's disease who meet the criteria for use of Levodopa/Carbidopa Intestinal Gel (LCIG) established in the summary of product characteristics, Spanish Neurology Society (SEN) guidelines, local/regional directories (CCAA) or site's protocols for use of LCIG in common clinical practice.
• The decision to treat with LCIG is made by the physician prior to any decision to approach the patient to participate in this study.
• Patients with a cognitive level enough to complete the questionnaires, confirmed by a Mini-mental state examination (MMSE) score of at least 26 points, according to the recommendation of the Movement Disorder Society (MDS) task force on dementia in Parkinson's Disease (PD)

Exclusion Criteria:

• LCIG's contraindications included in the Summary of Product Characteristics (product label)