Status:
COMPLETED
Patient- and Caregiver-reported Symptoms and Outcomes With Levodopa/Carbidopa Intestinal Gel for the Treatment of Advanced Parkinson's Disease
Lead Sponsor:
AbbVie
Conditions:
Parkinson's Disease
Eligibility:
All Genders
18-99 years
Brief Summary
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 o...
Eligibility Criteria
Inclusion
- 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
- LCIG's contraindications included in the Summary of Product Characteristics (product label)
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT02289729
Start Date
October 1 2014
End Date
November 1 2016
Last Update
January 30 2019
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