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

AbbVie

Status: Completed

Conditions: Parkinson's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT02289729

P14-335

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

62 participants in 1 patient group

All Participants

Description:

Levodopa/carbidopa intestinal gel (LCIG) prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.